TriActive Dental Implant System

K261392 · Paragon Implant Mfg., LLC · DZE · Sep 17, 2026 · Dental

Device Facts

• Record ID: K261392
• Device Name: TriActive Dental Implant System
• Applicant: Paragon Implant Mfg., LLC
• Product Code: DZE · Dental
• Decision Date: Sep 17, 2026
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

TriActive implants are two-piece implants for one- or two-stage surgical procedures. These implants are indicated for use in partially or fully edentulous upper and lower jaws in support of single- or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework. TriActive Implants can be indicated for immediate function when initial implant stability has been achieved and with appropriate occlusal loading. Short (<8.5mmL) TriActive Implants: Indicated for single tooth (mandibular and maxillary central and lateral incisors), multiple tooth replacements or denture stabilization. Narrow (<3.7mmD) TriActive Implants are indicated for single tooth replacement of mandibular central and lateral incisors, and maxillary lateral incisors, or splinted to other dental implants for multi-unit fixed or removable partial prostheses, or for denture stabilization. The TriActive Abutment System is intended for use with TriActive dental implants in the maxillary and/or mandibular arches to provide support for crowns, bridges, or overdentures for edentulous or partially edentulous patients, using traditional crown & bridge techniques. All digitally designed custom abutments for use with DESS Bases or Blanks are to be sent to a Terrats Medical SL validated milling center for manufacture. The TriActive Implant bodies are indicated for compatibility with the following abutments systems: - Ti-base Abutments manufactured by Terrats Medical SL., platform NP and RP, Straight, max 0 degrees o Active Hex - Ti-blank Abutments manufactured by Terrats Medical SL., platform NP and RP, Straight, max 0 degrees o Active Hex - CoCr Base Abutments manufactured by Terrats Medical SL., platform NP and RP, Straight, max 0 degrees o Active Hex - CoCr Blank Abutments manufactured by Terrats Medical SL., platform NP and RP, Straight, max 0 degrees o Active Hex - Angled Multi-Unit Abutments manufactured by Terrats Medical SL., platform NP and RP, Angled, max 30 degrees o Active Hex - Stock Straight Abutments manufactured by Terrats Medical SL., platform NP and RP, Straight, max 0 degrees o Active Hex - Locator Abutments manufactured by Terrats Medical SL., platform NP and RP, Straight, max 0 degrees o Active Hex

Device Story

TriActive Dental Implant System comprises root-form endosseous implants, abutments, and prosthetic components for anchoring tooth replacements in edentulous/partially edentulous patients. Implants feature titanium alloy (Ti-6Al-4V ELI) construction; tapered, triple-lead, reverse-buttress thread profile; and microtextured surface-roughened finish. Coronal section includes machined, anodized collar (gold/rose gold). Implants placed surgically in jawbone; one- or two-stage procedures. System includes compatibility with specific Terrats Medical SL (DESS) abutments. Clinicians use system to restore esthetics and chewing function. Output is stable foundation for crowns, bridges, or overdentures. Benefits include restoration of oral function and patient esthetics.

Clinical Evidence

No clinical data included. Substantial equivalence supported by non-clinical bench testing: chemical characterization, biocompatibility (ISO 10993/7405), sterilization validation (ISO 11137-2/17665), fatigue testing (ISO 14801), insertion/seating torque, axial pull-out, and MRI safety (ASTM F2052/F2119/F2182/F2213).

Technological Characteristics

Materials: Titanium alloy (Ti-6Al-4V ELI) per ASTM F136-13. Design: Threaded root-form, triple-lead reverse-buttress threads, conical connection with internal hex. Surface: Anodized collar, blasted microtextured body. Sterilization: Gamma irradiation (sterile components) or steam sterilization (non-sterile components). Dimensions: 3.25mm-5.5mm diameter, 7mm-15mm length.

Indications for Use

Indicated for partially or fully edentulous upper/lower jaws; single or multiple-unit restorations; terminal or intermediate abutment support for fixed bridgework. Immediate function indicated with sufficient stability. Short (<8.5mmL) implants for single tooth (incisors), multiple tooth, or denture stabilization. Narrow (<3.7mmD) implants for single tooth (incisors) or splinted multi-unit/denture stabilization.

Regulatory Classification

Identification

An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.

Special Controls

*Classification.* (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2) *Classification.* Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use; (ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads; (iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system; (iv) The device must be demonstrated to be biocompatible; (v) Sterility testing must demonstrate the sterility of the device; (vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment; (vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians; (viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and (ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.

Predicate Devices

• GEN5 and GEN5+ Dental Implant System (K251938)

Reference Devices

• NobelActive (K142260)
• Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants (K192221)
• InterActive/SwishPlus2 Implant System (K130572)
• TiUltra Implants and Xeal Abutments (K202344)
• DESS Dental Smart Solutions (K170588)
• DESS Dental Smart Solutions (K173908)
• DESS Dental Smart Solutions (K191986)
• DESS Dental Smart Solutions (K203464)
• DESS Dental Smart Solutions (K212628)
• DESS Dental Smart Solutions (K233316)
• DESS Dental Smart Solutions (K240208)
• DESS Dental Smart Solutions (K252384)

Submission Summary (Full Text)

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FDA

U.S. FOOD & DRUG

ADMINISTRATION

Paragon Implant Mfg., LLC

Renee Bennett

Regulatory Affairs Manager

27030 Malibu Hills Rd.

Calabasas, California 91301

September 17, 2026

Re: K261392

Trade/Device Name: TriActive Dental Implant System

Regulation Number: 21 CFR 872.3640

Regulation Name: Endosseous Dental Implant

Regulatory Class: Class II

Product Code: DZE, NHA

Dated: September 14, 2026

Received: September 15, 2026

Dear Renee Bennett:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

U.S. Food & Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993

www.fda.gov

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K261392 - Renee Bennett

Page 2

Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

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K261392 - Renee Bennett

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For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

ANDREW I. STEEN
-S

Andrew I. Steen

Assistant Director

DHT1B: Division of Dental and ENT Devices

OHT1: Office of Ophthalmic, Anesthesia,

Respiratory, ENT, and Dental Devices

Office of Product Evaluation and Quality

Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

# Indications for Use

Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2023

See PRA Statement below.

510(k) Number (if known)

K261392

Device Name

TriActive Dental Implant System

# Indications for Use (Describe)

TriActive implants are two-piece implants for one- or two-stage surgical procedures. These implants are indicated for use in partially or fully edentulous upper and lower jaws in support of single- or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.

TriActive Implants can be indicated for immediate function when initial implant stability has been achieved and with appropriate occlusal loading.

Short (<8.5mmL) TriActive Implants: Indicated for single tooth (mandibular and maxillary central and lateral incisors), multiple tooth replacements or denture stabilization.

Narrow (<3.7mmD) TriActive Implants are indicated for single tooth replacement of mandibular central and lateral incisors, and maxillary lateral incisors, or splinted to other dental implants for multi-unit fixed or removable partial prostheses, or for denture stabilization.

The TriActive Abutment System is intended for use with TriActive dental implants in the maxillary and/or mandibular arches to provide support for crowns, bridges, or overdentures for edentulous or partially edentulous patients, using traditional crown & bridge techniques.

All digitally designed custom abutments for use with DESS Bases or Blanks are to be sent to a Terrats Medical SL validated milling center for manufacture.

The TriActive Implant bodies are indicated for compatibility with the following abutments systems:

- Ti-base Abutments manufactured by Terrats Medical SL., platform NP and RP, Straight, max 0 degrees
o Active Hex
- Ti-blank Abutments manufactured by Terrats Medical SL., platform NP and RP, Straight, max 0 degrees
o Active Hex
- CoCr Base Abutments manufactured by Terrats Medical SL., platform NP and RP, Straight, max 0 degrees
o Active Hex
- CoCr Blank Abutments manufactured by Terrats Medical SL., platform NP and RP, Straight, max 0 degrees
o Active Hex
- Angled Multi-Unit Abutments manufactured by Terrats Medical SL., platform NP and RP, Angled, max 30 degrees
o Active Hex
- Stock Straight Abutments manufactured by Terrats Medical SL., platform NP and RP, Straight, max 0 degrees
o Active Hex
- Locator Abutments manufactured by Terrats Medical SL., platform NP and RP, Straight, max 0 degrees
o Active Hex

Type of Use (Select one or both, as applicable)

☑

Prescription Use (Part 21 CFR 801 Subpart D)

☐

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

FORM FDA 3881 (6/20)

Page 1 of 2

PSC Publishing Services [phone]

EF

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This section applies only to requirements of the Paperwork Reduction Act of 1995.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services

Food and Drug Administration

Office of Chief Information Officer

Paperwork Reduction Act (PRA) Staff

[e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (6/20)

Page 2 of 2

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510(k) Summary

TriActive Dental Implant System

K261392

Page 1 of 25

### 510(k) Summary

### Paragon Implant Mfg., LLC

### TriActive Dental Implant System

### September 16, 2026

### Submitter

Paragon Implant Mfg., LLC

27030 Malibu Hills Road

Calabasas Hills, CA 91301, U.S.A.

Telephone: [phone]

### Official Contact

Renee Bennett, Manager of Regulatory Affairs

Paragon Implant Mfg., LLC

27030 Malibu Hills Road

Calabasas Hills, CA 91301

Telephone: [phone] ext. 218

Email: [e-mail]

### Device Name and Classification

Name of Device

TriActive Dental Implant System

Common or Usual Name

Endosseous dental implant

Regulation Number

21 CFR § 872.3640

Regulation Name

Implant, Endosseous, Root-Form

Regulatory Class

Class II

Product Code(s)

DZE; NHA

Legally Marketed Predicate Device(s)

Primary Predicate Device (DZE - Implants)

K251938 (GEN5 and GEN5+ Dental Implant System),
Paragon Implant Mfg, LLC

Reference Device (DZE - Implants)

K142260 (NobelActive), NobelActive AB

K192221 (Legacy2, Legacy3, Legacy4, simplyLegacy2,
simplyLegacy3 dental implants; Legacy2, Legacy3, Legacy4
fixture-mounts), Implant Direct Sybron Manufacturing,
LLC

K130572 (InterActive/SwishPlus2 Implant System),
Implant Direct Sybron Manufacturing, LLC

K202344 (TiUltra Implants and Xeal Abutments),
NobelActive AB

Primary Predicate Device (NHA - Abutments)

K251938 (GEN5 and GEN5+ Dental Implant System),
Paragon Implant Mfg, LLC

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510(k) Summary

TriActive Dental Implant System

K261392

Page 2 of 25

Reference Devices (NHA – Abutments)

K170588 (DESS Dental Smart Solutions),
Terrats Medical SL

K173908 (DESS Dental Smart Solutions),
Terrats Medical SL

K191986 (DESS Dental Smart Solutions),
Terrats Medical SL

K203464 (DESS Dental Smart Solutions),
Terrats Medical SL

K212628 (DESS Dental Smart Solutions),
Terrats Medical SL

K233316 (DESS Dental Smart Solutions),
Terrats Medical SL

K240208 (DESS Dental Smart Solutions),
Terrats Medical SL

K252384 (DESS Dental Smart Solutions),
Terrats Medical SL

## INDICATIONS FOR USE STATEMENT

TriActive implants are two-piece implants for one- or two-stage surgical procedures. These implants are indicated for use in partially or fully edentulous upper and lower jaws in support of single- or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.

TriActive Implants can be indicated for immediate function when initial implant stability has been achieved and with appropriate occlusal loading.

Short (<8.5mmL) TriActive Implants: Indicated for single tooth (mandibular and maxillary central and lateral incisors), multiple tooth replacements or denture stabilization.

Narrow (<3.7mmD) TriActive Implants are indicated for single tooth replacement of mandibular central and lateral incisors, and maxillary lateral incisors, or splinted to other dental implants for multi-unit fixed or removable partial prostheses, or for denture stabilization.

The TriActive Abutment System is intended for use with TriActive dental implants in the maxillary and/or mandibular arches to provide support for crowns, bridges, or overdentures for edentulous or partially edentulous patients, using traditional crown & bridge techniques.

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510(k) Summary

TriActive Dental Implant System

K261392

Page 3 of 25

All digitally designed custom abutments for use with DESS Bases or Blanks are to be sent to a Terrats Medical SL validated milling center for manufacture.

The TriActive Implant bodies are indicated for compatibility with the following abutments systems:

- Ti-base Abutments manufactured by Terrats Medical SL., platform NP and RP, Straight, max 0 degrees
- Active Hex
- Ti-blank Abutments manufactured by Terrats Medical SL., platform NP and RP, Straight, max 0 degrees
- Active Hex
- CoCr Base Abutments manufactured by Terrats Medical SL., platform NP and RP, Straight, max 0 degrees
- Active Hex
- CoCr Blank Abutments manufactured by Terrats Medical SL., platform NP and RP, Straight, max 0 degrees
- Active Hex
- Angled Multi-Unit Abutments manufactured by Terrats Medical SL., platform NP and RP, Angled, max 30 degrees
- Active Hex
- Stock Straight Abutments manufactured by Terrats Medical SL., platform NP and RP, Straight, max 0 degrees
- Active Hex
- Locator Abutments manufactured by Terrats Medical SL., platform NP and RP, Straight, max 0 degrees
- Active Hex

## SUBJECT DEVICE DESCRIPTION

The TriActive Dental Implant System consists of a root form endosseous dental implant, endosseous dental implant abutments, and various other prosthetic/restorative components (medical devices) to plan, implant, and support restorations for edentulous patients.

TriActive dental implants are two-piece endosseous dental implants intended to be surgically placed in the upper or lower jawbone for anchoring or supporting tooth replacements to restore patient esthetics and chewing function. TriActive implants are for one- or two-stage surgical procedures. These implants are indicated for use in partially or fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework. All TriActive Implants are indicated for bone-level placement. With some exceptions, most TriActive Implants are indicated for 1mm supra-crestal placement in bone.

TriActive implants are available as narrow diameter (<3.7mmD) and standard diameter (3.7mmD to 5.5mmD) with lengths ranging from 7mm to 15mm.

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510(k) Summary

TriActive Dental Implant System

K261392

Page 4 of 25

The TriActive Implants are manufactured from titanium alloy (Ti-6Al-4V ELI) complying with standard ASTM F136-13 - Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant.

The TriActive Implants are composed of an upper and lower section. With the exception of the 5.5mm diameter implant, the upper (coronal) section is characterized by its cylindrical, grooved profile and machined, anodized surface finish. The coronal section of the 5.5mm diameter TriActive implant also possesses a grooved and machined anodized surface finish but possesses a back-taper. Narrow TriActive Implants (<3.7mmD) are anodized rose gold, while the remaining diameters are anodized gold. The lower section of the TriActive Implant is characterized by its tapered, triple-lead, reverse-buttress threading profile, and a surface-roughened finish. Narrow diameter TriActive Implants are designed with one clockwise cutting groove for insertion and one counterclockwise cutting groove for withdrawal. The standard diameter implants are designed with two clockwise cutting grooves and one counterclockwise cutting flute.

The narrow diameter TriActive implants possess a 3.0mm platform conical connection, a 2.3mm internal hex, and M1.6 internal threading. The standard diameter implants possess a 3.4mm platform conical connection with a 2.7mm internal hex, and M2.0 internal threading.

The TriActive Implants are anodized as a gold or rose gold color with a portion of the Implant going through a surface treatment (blasting) to create a microtextured surface roughness.

These implants (and the devices included in the packaging) are sold sterile.

Standard Length (>7mmL) and Regular (≥3.7mmD) TriActive Implants can be placed up to 1mm supra-crestal at the discretion of the clinician.

The various devices included in the TriActive Implant System (such as Endosseous dental implant abutments, cover screws, fixation screw, etc.) and various other prosthetic/restorative components used to plan, implant, and support restorations for fully and partially edentulous patients are offered in compatible platform dimensions to enable a complete dental restoration.

The Cover Screws, Abutments, and fixations screws are all manufactured from titanium alloy (Ti-6Al-4V ELI) complying with standard ASTM F136-13 - Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant).

TriActive Implants are surgically compatible with NobelActive drills using the surgical protocol provided in the labeling.

All TriActive implant diameters and lengths fitted with Extender Healing Abutments are prosthetically compatible with corresponding TriActive Healing and Prosthetic Components.

TriActive Implants are designed to be prosthetically compatible with DESS (Terrats Medical SL) clone NobelActive Conical Connection Abutments including Straight Ti and CoCr Base Abutments, Straight Ti and

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510(k) Summary

TriActive Dental Implant System

K261392

Page 5 of 25

CoCr Blank Abutments, Angled Multi-Unit Abutments, and stock Straight Abutments (DESS Dental Smart Solutions: K170588, K173908, K191986, K203464, K212628, K233316, K240208, K252384).

| 510(k) Clearance # | Reference Device: K170588 DESS Dental Smart Solutions Terrats Medical SL | Reference Device: K173908 DESS Dental Smart Solutions Terrats Medical SL | Reference Device: K191986 DESS Dental Smart Solutions Terrats Medical SL | Reference Device: K203464 DESS Dental Smart Solutions Terrats Medical SL | Reference Device: K212628 DESS Dental Smart Solutions Terrats Medical SL | Reference Device: K233316 DESS Dental Smart Solutions Terrats Medical SL | Reference Device: K240208 DESS Dental Smart Solutions Terrats Medical SL | Reference Device: K252384 DESS Dental Smart Solutions Terrats Medical SL |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Device Names | Abutments (Healing, Temporary, Straight, TiBase, Pre- milled Blank, DESS LOC, Multi-Unit) | Abutments (Aurum Base, CoCr Pre-milled Blank, CoCr Abutment) | Abutments (Multi-Unit Angled, TiBase, TiBlank) | Abutments (TiBase, C- Base) | Abutments (Healing, Straight Multi-Unit, DESSLoc, Ti-Bases, Ti-Blanks) | Abutments (Healing, Temporary, Multi-Unit Straight, Multi-Unit Angled) | Abutments (Ti-Base, Pre-Milled Blank, Healing, Temporary) | Abutments (Pre-Milled Blank, Multi-Unit Straight, Multi-Unit Angled) |

Standard Length (≥8.5mmL) TriActive Implants are prosthetically compatible with DESS® (Terrats Medical SL) NobelActive Conical Connection Abutments and implant drivers (NP and RP Conical Connection Implant Drivers).

Short (<8.5mmL) TriActive Implants are not prosthetically compatible with DESS® (Terrats Medical SL) NobelActive Conical Connection Abutments and can only be restored with TriActive extender healing and restorative components. Short TriActive Implants are compatible with DESS® (Terrats Medical SL) implant drivers (NP and RP Conical Connection Implant Drivers).

TriActive implants fitted with Extender Healing Abutments are not prosthetically compatible with Paragon Implant GEN5+ extender-level Healing and Restorative Components.

Standard configuration Extender Multi-unit Abutments are compatible with Paragon Implant, GEN5 Standard MUA Copings (for M1.4 threaded connections).

Low-Profile configuration Extender Multi-unit Abutments are compatible with Paragon Implant, GEN5 Low-Profile MUA Copings (for 1-72 UNF threaded connections).

### PERFORMANCE DATA

Non-clinical data submitted to demonstrate substantial equivalence included:

- Chemical characterization and biocompatibility validations per ISO 10993 and ISO 7405 has been leveraged from the K251938 (GEN5 and GEN5+ Dental Implant System) submission, as the subject devices have identical materials and manufacturing.
- Sterilization validation for all devices sold sterile per ANSI/AAMI/ISO 11137-2.
- Cleaning and sterilization validations for all devices sold non-sterile per ISO 17664-1, AAMI TIR12, and ISO17665.
- Fatigue (Dynamic Load) testing following ISO 14801 and Class II FDA Special Controls Guidance for worst-case dental implant system configurations containing angled abutments.

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510(k) Summary

TriActive Dental Implant System

K261392

Page 6 of 25

- Insertion/Seating Torque and axial pull-out load testing for validation of use of the NobelActive surgical drills.
- Simulation and Physical MRI validations per ASTM F2052, ASTM F2119, ASTM F2182, and ASTM F2213. It was determined that the subject devices are not a new worst case compared to K251938 (GEN5 and GEN5+ Dental Implant System) for behavior in the MR environment.
- Accelerated aging per ASTM F1980-21 Because the packaging is a vial with a cap, determination of shelf-life by means of conventional package integrity testing after aging is not applicable. Therefore, shelf-life of the sterile barrier was determined by membrane filtration sterility testing of the interior of the vial according to ISO 11737-2 after accelerated aging according to ASTM F1980.
- No clinical data was included in this submission.

## EQUIVALENCE TO MARKETED DEVICES

The proposed TriActive Dental Implant System consists of root-form Endosseous dental implants, Endosseous dental implant abutments, and various other prosthetic/restorative components (medical devices) to plan, implant, and support restorations for edentulous patients.

The Indications for Use of the subject device is similar to the primary predicate (K251938). The subject device considers short implants to be <8.5mmL while the primary predicate (K251938) considers short implants to be <9mmL. The subject device includes an indication for narrow implants while the primary predicate (K251938) does not. The subject device includes compatibility claims which the primary predicate (K251938) does not.

The threaded root form implants are manufactured from the identical raw material (Ti-6Al-4V ELI per complying with standard ASTM F136-13) that undergo the identical manufacturing process as the reference device (K251938). Both the proposed and reference device (K251938) are anodized and blasted with a soluble blast media to create a microtextured surface roughness below the bone level region of the Implant.

The conical connection of the proposed implants has similar angulation as the predicate device ( K251938). The implant-abutment conical connection is identical to that of the predicate devices (K251938). The proposed Implant diameters correspond to the various diameters offered by the predicate devices (K142260).

The proposed implants have a machined anodized collar, with the anodized portion being substantially equivalent to the reference device (K251938), length, surface roughness and surface thickness. The blasted portion of the proposed device has the identical surface roughness as that of the reference device (K251938).

The proposed implants have triple-lead reverse buttress threads while the predicate device (K251938) has double-lead reverse buttress threads. The lower tapered portion of the proposed device has one forward and one reverse cutting flute (NP 3.0mm) or two forward and one reverse (RP 3.4mm) while the predicate device (K251938) has double forward cutting flutes.

{11}

510(k) Summary

TriActive Dental Implant System

K261392

Page 7 of 25

The body diameters of the proposed implants are within the same range to those body diameters of the predicate devices (K251938 and K130572). TriActive Implants are offered at body diameters of 3.25mm, 3.7mm, 4.3mm, 4.9mm, and 5.5mm.

The lengths of the proposed implants are similar to those of the predicate device (K251938). TriActive Implants are within the same range offered at 7mm, 8.5mm, 10mm, 11.5mm, 13mm, and 15mm length diameters.

The platforms of the proposed implants are similar to the predicate device (K251938). TriActive Implants are offered at 3.0mm and 3.4mm platforms.

The additional devices provided inside the implant packaging differ from the proposed device and predicate device (K251938).

Both the proposed implants and the reference devices (K251938, K192221 and K130572) are packaged in a vial and cap with labels. The Implants, Healing Abutments, and Cover Screws of the proposed and predicate/reference devices (K142260, K251938, K192221, K130572, and K202344) are single-use and delivered sterile (gamma irradiated) while all other components are single-use and delivered non-sterile and sterilized by the end user via steam sterilization per the Instructions for Use (IFU).

The proposed healing abutments and cover screws in the subject submission and the reference submission (K251938) have a similar general design, intended use, connection type, sterilization, sterilization method, SAL, usage, materials, collar heights, post heights, and finish. They have similar range of diameters, screw sizes, and platform ranges.

The proposed extender abutments in the subject submission and the reference submission (K215938) have a similar general design, intended use, connection type, sterilization, sterilization methods, SAL, usage, materials, platform sizes, and finish. They have similar diameter ranges, screw sizes, and post heights.

The proposed Extender NizLoc Abutments and predicate DESSLoc® Abutments (K170588) have a similar general design, intended use, sterilization, sterilization method, SAL, usage, materials, and screw size. They have similar diameters, connection types, platform size range, and collar height range. They have a different finish.

Table 1. Substantial Equivalence Comparison in Tabular Format outlines the Intended Use and Technological Characteristics of the subject devices, the predicate, and each reference device.

## CONCLUSION

The subject devices, the primary predicate devices, and the reference devices have the identical intended use, have similar technological characteristics, and are made of similar materials. The subject devices and the predicate/reference devices encompass la similar range of physical dimensions, are packaged in similar materials, and are sterilized using similar methods. The data included in this submission demonstrates substantial equivalence to the predicate devices listed above.

Table 1. Substantial Equivalence Comparison in Tabular Format

{12}

510(k) Summary
TriActive Dental Implant System
K261392

Page 8 of 25

# **SUBSTANTIAL EQUIVALENCE COMPARISON IN TABULAR FORMAT**

| Characteristic | Proposed Device: (K261392) TriActive Dental Implant System, Paragon Implant Mfg, LLC | Primary Device: (K251938) GEN5^{TM} and GEN5+^{TM} Dental Implant System, Paragon Implant Mfg, LLC | Reference Predicate Device: (K142260) NobelActive^{®}, NobelActive AB | Reference Device: (K192221) Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants; Legacy2, Legacy3, Legacy4 fixture- mounts, Implant Direct Sybron Manufacturing, LLC | Reference Device: (K130572) InterActive/SwishPlus2 Implant System, Implant Direct Sybron Manufacturing, LLC | Reference Device: (K202344) TiUltra Implants and Xea1 Abutments, NobelActive AB |
| --- | --- | --- | --- | --- | --- | --- |
| Design / Image | | | | | | |
| Regulation Number | 21 C.F.R. § 872.3640 (Endosseous dental implants) | 21 C.F.R. § 872.3640 (Endosseous dental implants) | 21 C.F.R. § 872.3640 (Endosseous dental implants) | 21 C.F.R. § 872.3640 (Endosseous dental implants) | 21 C.F.R. § 872.3640 (Endosseous dental implants) | 21 C.F.R. § 872.3640 (Endosseous dental implants) |
| Classification | Class II | Class II | Class II | Class II | Class II | Class II |
| Primary Product Code | DZE | DZE | DZE | DZE | DZE | DZE |
| Materials | Titanium 6AL-4V ELI | Titanium 6AL-4V ELI | CP Titanium | Titanium 6AL4V ELI | Titanium 6AL-4V ELI | CP Titanium |
| Reason for Predicate / Reference | N/A | - Indications for Use - General Design - Conical Connection - Internal hex - Body Diameters - Implant Lengths - Platform - Collar design, anodized machined endosseous collar with horizontal grooves | - General Design - Body Diameter Dimension - Conical Connection - Implant Length - Platform - Screw - Sterilization - Usage | - Thread Shape - Available Surface Area Comparison - Bone-to-Implant Contact Comparison | - Body Diameter Dimensions - Thread Shape - Conical Connection | - Anodized collar - Body Diameter Dimensions - Conical Connection |

{13}

510(k) Summary

TriActive Dental Implant System

K261392

Page 9 of 25

| Characteristic | Proposed Device: (K261392) TriActive Dental Implant System, Paragon Implant Mfg, LLC | Primary Device: (K251938) GEN5™ and GEN5+™ Dental Implant System, Paragon Implant Mfg, LLC | Reference Predicate Device: (K142260) NobelActive®, NobelActive AB | Reference Device: (K192221) Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants; Legacy2, Legacy3, Legacy4 fixture- mounts, Implant Direct Sybron Manufacturing, LLC | Reference Device: (K130572) InterActive/SwishPlus2 Implant System, Implant Direct Sybron Manufacturing, LLC | Reference Device: (K202344) TiUltra Implants and XeaI Abutments, NobelActive AB |
| --- | --- | --- | --- | --- | --- | --- |
| | | • Cleanliness • Biocompatibility • Sterilization • Usage | | | | |
| General Design | Threaded Root form implant | Threaded Root form implant | Threaded Root form implant | Threaded Root form implant | Threaded groove, root form endosteal implant | Threaded Root form implant |
| Indications for Use | TriActive implants are two- piece implants for one- or two-stage surgical procedures. These implants are indicated for use in partially or fully edentulous upper and lower jaws in support of single- or multiple- unit restorations and terminal or intermediate abutment support for fixed bridgework. TriActive Implants can be indicated for immediate function when initial implant stability has been achieved and with appropriate occlusal loading. Short (<8.5mmL) TriActive Implants: Indicated for single tooth (mandibular and maxillary central and lateral incisors), multiple tooth replacements or denture stabilization. | GEN5 and GEN5 Implants: GEN5 and GEN5+ implants are two-piece implants for one-stage or two-stage surgical procedures. These implants are intended for use in partially or fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework. Implants can be indicated for immediate function when initial implant stability has been achieved and with appropriate occlusal loading. | NobelActive® implants are endosseous implants intended to be surgically placed in the upper or lower jawbone for anchoring or supporting tooth replacements to restore patient esthetics and chewing function. NobelActive® implants are indicated for single or multiple unit restorations in splinted or non- splinted applications. This can be achieved by a 2- stage or 1-stage surgical technique in combination with immediate, early or delayed loading protocols, recognizing sufficient primary stability | Legacy2, simplyLegacy2, Legacy3, simplyLegacy3, and Legacy4 dental implants are two-piece implants for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework. Implants can be indicated for immediate loading when good primary stability has been achieved and with appropriate occlusal loading. | Implant System consists of two-piece implants for one-stage or two- stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework. Implants can be indicated for immediate loading when good primary stability has been achieved and with appropriate occlusal loading. | NobelActive TiUltra implants are endosseous implants intended to be surgically placed in the upper or lower jaw bone for anchoring or supporting tooth replacements to restore patient esthetics and chewing function. NobelActive TiUltra implants are indicated for single or multiple unit restorations in splinted or non- splinted applications. This |

{14}

510(k) Summary

TriActive Dental Implant System

K261392

Page 10 of 25

| Characteristic | Proposed Device: (K261392) TriActive Dental Implant System, Paragon Implant Mfg, LLC | Primary Device: (K251938) GEN5™ and GEN5+™ Dental Implant System, Paragon Implant Mfg, LLC | Reference Predicate Device: (K142260) NobelActive®, NobelActive AB | Reference Device: (K192221) Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants; Legacy2, Legacy3, Legacy4 fixture- mounts, Implant Direct Sybron Manufacturing, LLC | Reference Device: (K130572) InterActive/SwishPlus2 Implant System, Implant Direct Sybron Manufacturing, LLC | Reference Device: (K202344) TiUltra Implants and Xea1 Abutments, NobelActive AB |
| --- | --- | --- | --- | --- | --- | --- |
| | Narrow (<3.7mmD) TriActive Implants are indicated for single tooth replacement of mandibular central and lateral incisors, and maxillary lateral incisors, or splinted to other dental implants for multi-unit fixed or removable partial prostheses, or for denture stabilization. The TriActive Abutment System is intended for use with TriActive dental implants in the maxillary and/or mandibular arches to provide support for crowns, bridges, or overdentures for edentulous or partially edentulous patients, using traditional crown & bridge techniques. All digitally designed custom abutments for use with DESS Bases or Blanks are to be sent to a Terrats Medical SL validated milling center for manufacture. | Short (<9mmL) Implants: Indicated for single tooth (mandibular and maxillary central and lateral incisors), multiple tooth replacements or denture stabilization. GEN5 and GEN5+ Abutment System: The GEN5 and GEN5+ Abutment System is intended for use with dental implants in the maxillary and/or mandibular arches to provide support for crowns, bridges, or overdentures for edentulous or partially edentulous patients, using traditional crown & bridge techniques. | and appropriate occlusal loading for the selected technique. NobelActive® 3.0 implants are intended to replace a lateral incisor in the maxilla and/or a central or lateral incisor in the mandible. NobelActive® 3.0 implants are indicated for single unit restorations only. | • Narrow (3.2mmD) implants: Indicated for single-tooth replacement (mandibular central and lateral incisors; maxillary lateral incisors), multiple-tooth replacements or denture stabilization. • Short (<10mm) 3.7mm implants: Indicated for single-tooth (mandibular and maxillary central and lateral incisors), multiple tooth replacements or denture stabilization. The Legacy 2, Legacy3, and Legacy4 fixture mounts are intended for use with the corresponding dental implants (Legacy2, Legacy3, and Legacy4, respectively). The fixture-mounts can function as an abutment. As an | • Narrow Diameter (3.2, 3.3mm) Implants: Indicated for single-tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors. Also indicated for multiple tooth replacements or denture stabilization. • Compatibility: InterActive & SwishActive implants are prosthetically compatible with InterActive 3.0 and 3.4mm abutments and Nobel Biocare conical connection NobelActive™ NP (Narrow Platform – 3.0mm diameter) and NobelActive™ RP (Regular Platform – 3.4mm diameter) titanium abutments. InterActive 3.0 and 3.4mm abutments are | can be achieved by a 2-stage or 1-stage surgical technique in combination with immediate, early or delayed loading protocols, recognizing sufficient primary stability and appropriate occlusal loading for the selected technique. NobelActive TiUltra 3.0 implants are intended to replace a lateral incisor in the maxilla and/or a central or lateral incisor in the mandible. NobelActive TiUltra 3.0 implants are indicated for single-unit restorations only. |

{15}

510(k) Summary

TriActive Dental Implant System

K261392

Page 11 of 25

| Characteristic | Proposed Device: (K261392) TriActive Dental Implant System, Paragon Implant Mfg, LLC | Primary Device: (K251938) GEN5™ and GEN5+™ Dental Implant System, Paragon Implant Mfg, LLC | Reference Predicate Device: (K142260) NobelActive®, NobelActive AB | Reference Device: (K192221) Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants; Legacy2, Legacy3, Legacy4 fixture- mounts, Implant Direct Sybron Manufacturing, LLC | Reference Device: (K130572) InterActive/SwishPlus2 Implant System, Implant Direct Sybron Manufacturing, LLC | Reference Device: (K202344) TiUltra Implants and XeaI Abutments, NobelActive AB |
| --- | --- | --- | --- | --- | --- | --- |
| | The TriActive Implant bodies are indicated for compatibility with the following abutments systems: • Ti-base Abutments manufactured by Terrats Medical SL., platform NP and RP, Straight, max 0 degrees ○ Active Hex • Ti-blank Abutments manufactured by Terrats Medical SL., platform NP and RP, Straight, max 0 degrees ○ Active Hex • CoCr Base Abutments manufactured by Terrats Medical SL., platform NP and RP, Straight, max 0 degrees ○ Active Hex • CoCr Blank Abutments manufactured by Terrats Medical SL., | | | abutment, fixture-mounts are intended for use with dental implants in the maxillary and/or mandibular arches to provide support for crowns or bridges for edentulous or partially edentulous patients. • Fixture-mounts as an abutment for narrow (3.2mmD) implants: Indicated for single-tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors. • Fixture-mounts as an abutment for short (8mm) 3.7mmD implants: Not intended for tooth replacement of canines, pre-molars or molars. Legacy2, simplyLegacy2, Legacy3, simplyLegacy3, and Legacy4 implants are compatible with Legacy | prosthetically compatible with Nobel Biocare conical connection NobelActive™ NP (Narrow Platform–3.0mm diameter) and NobelActive™ RP (Regular Platform – 3.4mm diameter) (3.5-5.0mmD, 8.5-18mm Length) implants. | |

{16}

510(k) Summary
TriActive Dental Implant System
K261392

Page 12 of 25

| Characteristic | Proposed Device: (K261392) TriActive Dental Implant System, Paragon Implant Mfg, LLC | Primary Device: (K251938) GEN5^{TM} and GEN5+^{TM} Dental Implant System, Paragon Implant Mfg, LLC | Reference Predicate Device: (K142260) NobelActive^{®}, NobelActive AB | Reference Device: (K192221) Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants; Legacy2, Legacy3, Legacy4 fixture- mounts, Implant Direct Sybron Manufacturing, LLC | Reference Device: (K130572) InterActive/SwishPlus2 Implant System, Implant Direct Sybron Manufacturing, LLC | Reference Device: (K202344) TiUltra Implants and Xeal Abutments, NobelActive AB |
| --- | --- | --- | --- | --- | --- | --- |
| | platform NP and RP, Straight, max 0 degrees ○ Active Hex • Angled Multi-Unit Abutments manufactured by Terrats Medical SL., platform NP and RP, Angled, max 30 degrees ○ Active Hex • Stock Straight Abutments manufactured by Terrats Medical SL., platform NP and RP, Straight, max 0 degrees ○ Active Hex • Locator Abutments manufactured by Terrats Medical SL., platform NP and RP, Straight, max 0 degrees ○ Active Hex | | | abutments (3.0mm, 3.5mm, 4.5mm, 5.7mm platform). | | |
| **Body Diameters** | 3.25mm, 3.7mm, 4.3mm, 4.9mm, 5.5mm | 3.7mm, 4.2mm, 4.7mm, 5.2mm, 5.7mm | 3.0mm, 3.5mm, 4.3mm, 5.0mm, 5.5mm | 3.2mm, 3.7mm, 4.2mm, 4.7mm, 5.2mm, 5.7mm, 7.0mm | 3.2mm; 3.7mm; 4.3mm; 5.0mm | 3.0mm, 3.5mm, 4.3mm, 5.0mm, 5.5mm |

{17}

510(k) Summary

TriActive Dental Implant System

K261392

Page 13 of 25

| Characteristic | Proposed Device: (K261392) TriActive Dental Implant System, Paragon Implant Mfg, LLC | Primary Device: (K251938) GEN5^{TM} and GEN5+^{TM} Dental Implant System, Paragon Implant Mfg, LLC | Reference Predicate Device: (K142260) NobelActive^{®}, NobelActive AB | Reference Device: (K192221) Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants; Legacy2, Legacy3, Legacy4 fixture- mounts, Implant Direct Sybron Manufacturing, LLC | Reference Device: (K130572) InterActive/SwishPlus2 Implant System, Implant Direct Sybron Manufacturing, LLC | Reference Device: (K202344) TiUltra Implants and Xea1 Abutments, NobelActive AB |
| --- | --- | --- | --- | --- | --- | --- |
| **Implant Lengths** | Ø3.25mm: 8.5mm, 10mm, 11.5mm, 13mm, 15mm Ø3.7mm, Ø4.3mm, Ø4.9mm, Ø5.5mm: 7mm, 8.5mm, 10mm, 11.5mm, 13mm, 15mm | Ø3.7mm; Ø4.2mm; Ø4.7mm; Ø5.2mm; Ø5.7mm: 7mm, 9mm, 11mm, 12.5mm, and 14mm | Ø3.0mm: 10mm, 11.5mm, 13mm, 15mm Ø3.5mm, Ø4.3mm, Ø5.0mm: 8.5mm, 10mm, 11.5mm, 13mm, 15mm, 18mm Ø5.5mm: 7mm, 8.5mm, 10mm, 11.5mm, 13mm, 15mm | Ø3.2mm: 3.0mm Ø3.7mm, Ø4.2mm, Ø4.7mm, Ø5.2mm, Ø5.7mm: 8mm, 10mm, 11.5mm, 13mm, 16mm Ø7.0mm: 8mm, 10mm, 11.5mm, 13mm | Ø3.2mm: 8mm; 10mm, 11.5mm, 13mm, 16mm Ø3.7mm; Ø4.3mm; Ø5.0mm: 6mm; 8mm; 10mm, 11.5mm, 13mm, 16mm | Ø3.0mm: 10mm, 11.5mm, 13mm, 15mm Ø3.5mm; Ø4.3mm; Ø5.0mm: 8.5mm, 10mm, 11.5mm, 13mm, 15mm, 18mm Ø5.5mm: 7mm, 8.5mm, 10mm, 11.5mm, 13mm, 15mm |
| **Implant Platform** | Ø3.25mm: 3.0mm Ø3.7mm, Ø4.3mm, Ø4.9mm, Ø5.5mm: 3.4mm | Ø3.7mm, Ø4.2mm: 3.5mm Ø4.7mm, Ø5.2mm, Ø5.7mm: 4.5mm | Ø3.0mm: 3.0mm Ø3.5mm: 3.5mm (NP) Ø4.3mm, Ø5.0mm: 3.9mm (RP) Ø5.5mm: 5.1mm (WP) | Ø3.2mm: 3.0mm Ø3.7mm, Ø4.2mm: 3.5mm Ø4.7mm, Ø5.2mm: 4.5mm Ø5.7mm, Ø7.0mm: 5.7mm | Ø3.2mm, Ø3.7mm: 3.0mm Ø 4.3mm; Ø 5.0mm: 3.4mm | Ø3.0mm: 3.0mm Ø3.5mm: NP (3.5mm) Ø4.3mm; 5.0mm: RP (3.9mm) Ø5.5mm: WP (5.1mm) |
| **Thread Design** | Triple-lead, reverse- buttress threads | Double-lead, reverse buttress threads | Double lead V-threads | Quadruple-lead micro- threads, buttress threads | Micro-grooves and micro-threads, Double | Double lead V- threads |

{18}

510(k) Summary

TriActive Dental Implant System

K261392

Page 14 of 25

| Characteristic | Proposed Device: (K261392) TriActive Dental Implant System, Paragon Implant Mfg, LLC | Primary Device: (K251938) GEN5™ and GEN5+™ Dental Implant System, Paragon Implant Mfg, LLC | Reference Predicate Device: (K142260) NobelActive®, NobelActive AB | Reference Device: (K192221) Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants; Legacy2, Legacy3, Legacy4 fixture- mounts, Implant Direct Sybron Manufacturing, LLC | Reference Device: (K130572) InterActive/SwishPlus2 Implant System, Implant Direct Sybron Manufacturing, LLC | Reference Device: (K202344) TiUltra Implants and Xeal Abutments, NobelActive AB |
| --- | --- | --- | --- | --- | --- | --- |
| | | | | | (2) lead reverse- buttress threads | |
| **Cutting Flutes** | NP (3.0mm): One forward and one reverse RP (3.4mm): Two forward and one reverse | Double (2) Forward | Double (2) Reverse | Double (2) Forward | Triple (3) Forward | Double (2) Reverse |
| **Connection Type** | Conical Connection with an Internal Hex | Internal hex | Internal Hex | Internal hex | Conical Internal Hex | Internal conical connection with hex interface |
| **Screw Size** | M1.6 and M2.0 | 1-72 UNF 2A | M1.6 and M2.0 | M1.6 and 1-72 UNF 2A | M1.6 | M1.6 and M2.0 |
| **Implant Assembly** | TriActive Implant is supplied with friction-fit Implant Carrier | GEN5 Implant Supplied with friction-fit Carrier; GEN5+ Implant: Supplied with pre-attached Implant Healing Abutment, Carrier and screw. | Implant is held in a titanium vial. The WP Implant comes with a co-packed Cover Screw. | Implant is assembled with one-piece (Legacy2, 3) or two-piece (Legacy4) fixture-mount. simplyLegacy2, 3: No carrier or fixture-mount. | Implant is assembled with a fixture-mount | Implant is held in a titanium vial. The WP Implant comes with a co- packed Cover Screw. |
| **Sterilization** | Implants, Extender Healing Abutments, Extender Cover Screws, and Cover Screws are supplied sterile; Provided sterile All other devices are supplied non-sterile. | Implants, Healing Abutments, and Cover Screws supplied sterile; Provided sterile All other devices supplied non-sterile. Devices steam sterilized (when | Provided sterile | Supplied sterile; fixture- mounts sterilized by end user when used as abutments. | Provided sterile | Provided sterile |

{19}

510(k) Summary

TriActive Dental Implant System

K261392

Page 15 of 25

| Characteristic | Proposed Device: (K261392) TriActive Dental Implant System, Paragon Implant Mfg, LLC | Primary Device: (K251938) GEN5™ and GEN5+™ Dental Implant System, Paragon Implant Mfg, LLC | Reference Predicate Device: (K142260) NobelActive®, NobelActive AB | Reference Device: (K192221) Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants; Legacy2, Legacy3, Legacy4 fixture- mounts, Implant Direct Sybron Manufacturing, LLC | Reference Device: (K130572) InterActive/SwishPlus2 Implant System, Implant Direct Sybron Manufacturing, LLC | Reference Device: (K202344) TiUltra Implants and Xeal Abutments, NobelActive AB |
| --- | --- | --- | --- | --- | --- | --- |
| | Devices steam sterilized (when applicable) by end user as per Instructions for Use (IFU) | applicable) by end user as per Instructions for Use (IFU) | | | | |
| **Sterilization Method** | Gamma Irradiation | Gamma Irradiation | Gamma Irradiation | Gamma Irradiation | Gamma Irradiation | Gamma Radiation |
| **SAL** | 10^{-6} | 10^{-6} | 10^{-6} | 10^{-6} | 10^{-6} | 10^{-6} |
| **Usage** | Single-patient, single-use | Single-patient, single-use | Single-patient, single-use | Single-patient, single-use | Single-patient, single-use | Single-patient, single-use |
| **Surface** | Resorbable Blast Media, 2.0mm machined, grooved, anodized section only at coronal end | Resorbable Blast Media, 2.0mm machined, grooved, anodized section only at coronal end | TiUnite® | SBM implant: HA blasted HA implant: HA blasted/HA coated | Soluble Blasted Media surface with roughness between 1.5µm and 2.3µm | TiUltra™ (Anodic oxidation) |

{20}

510(k) Summary

TriActive Dental Implant System

K261392

Page 16 of 25

# **ABUTMENTS AND OTHER PROSTHETIC COMPONENTS:**

| | Extender Straight Abutments | Implant Cover Screws | Extender Cover Screws | Extender NizLoc Abutments | Extender Angled Screw Channel (ASC) Abutments | Extender Temporary Abutments | Extender Healing Abutments | Extender Multi-Unit Abutment (MUA) Screws |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Device Image | | | | | | | | |

# **Extender Healing Abutments & Cover Screws:**

| Characteristic | Subject Device: K261392 TriActive Dental Implant System Paragon Implant Mfg, LLC | Predicate Device: K251938 GEN5™ and GEN5+™ Dental Implant System Paragon Implant Mfg, LLC |
| --- | --- | --- |
| **Device** | Extender Healing Abutments & Cover Screws | Extender Healing Abutments & Cover Screws |
| **Regulation Number** | 21 C.F.R. § 872.3630 (Endosseous dental implant abutment) | 21 C.F.R. § 872.3630 (Endosseous dental implant abutment) |
| **Classification** | Class II | Class II |
| **Primary Product Code** | NHA | NHA |
| **Reason for Predicate/Reference** | N/A | - Similar General Design - Identical Intended Use - Similar Range Diameters: Subject smallest is 3.2mm while predicate is 3.7mm. Subject largest is 5.5mm while predicate is 5.7mm. - Similar Connection Type - Identical Sterilization, Sterilization Method, and SAL - Identical Usage - Identical Materials - Similar Screw Size: Subject is M1.6 or M2.0 while predicate is 1-72 UNF. - Similar Range Platform: Subject smallest is 3.0mm while predicate is 3.5mm. Subject largest is 3.4mm while predicate is 5.7mm. - Similar Collar height - Similar Post height - Identical finish |

{21}

510(k) Summary

TriActive Dental Implant System

K261392

Page 17 of 25

| Characteristic | Subject Device: K261392 TriActive Dental Implant System Paragon Implant Mfg, LLC | Predicate Device: K251938 GEN5™ and GEN5+™ Dental Implant System Paragon Implant Mfg, LLC |
| --- | --- | --- |
| Device | Extender Healing Abutments & Cover Screws | Extender Healing Abutments & Cover Screws |
| Indications for Use | TriActive implants are two-piece implants for one- or two-stage surgical procedures. These implants are indicated for use in partially or fully edentulous upper and lower jaws in support of single- or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework. TriActive Implants can be indicated for immediate function when initial implant stability has been achieved and with appropriate occlusal loading. Short (<8.5mmL) TriActive Implants: Indicated for single tooth (mandibular and maxillary central and lateral incisors), multiple tooth replacements or denture stabilization. Narrow (<3.7mmD) TriActive Implants are indicated for single tooth replacement of mandibular central and lateral incisors, and maxillary lateral incisors, or splinted to other dental implants for multi-unit fixed or removable partial prostheses, or for denture stabilization. The TriActive Abutment System is intended for use with TriActive dental implants in the maxillary and/or mandibular arches to provide support for crowns, bridges, or overdentures for edentulous or partially edentulous patients, using traditional crown & bridge techniques. All digitally designed custom abutments for use with DESS Bases or Blanks are to be sent to a Terrats Medical SL validated milling center for manufacture. The TriActive Implant bodies are indicated for compatibility with the following abutments systems: • Ti-base Abutments manufactured by Terrats Medical SL., platform NP and RP, Straight, max 0 degrees ○ Active Hex | The GEN5 and GEN5+ Abutment System is intended for use with dental implants in the maxillary and/or mandibular arches to provide support for crowns, bridges, or overdentures for edentulous or partially edentulous patients, using traditional crown & bridge techniques. |

{22}

510(k) Summary

TriActive Dental Implant System

K261392

Page 18 of 25

| Characteristic | Subject Device: K261392 TriActive Dental Implant System Paragon Implant Mfg, LLC | Predicate Device: K251938 GEN5™ and GEN5+™ Dental Implant System Paragon Implant Mfg, LLC |
| --- | --- | --- |
| Device | Extender Healing Abutments & Cover Screws | Extender Healing Abutments & Cover Screws |
| | - Ti-blank Abutments manufactured by Terrats Medical SL., platform NP and RP, Straight, max 0 degrees - Active Hex - CoCr Base Abutments manufactured by Terrats Medical SL., platform NP and RP, Straight, max 0 degrees - Active Hex - CoCr Blank Abutments manufactured by Terrats Medical SL., platform NP and RP, Straight, max 0 degrees - Active Hex - Angled Multi-Unit Abutments manufactured by Terrats Medical SL., platform NP and RP, Angled, max 30 degrees - Active Hex - Stock Straight Abutments manufactured by Terrats Medical SL., platform NP and RP, Straight, max 0 degrees - Active Hex - Locator Abutments manufactured by Terrats Medical SL., platform NP and RP, Straight, max 0 degrees - Active Hex | |
| Material | Titanium 6AL-4V ELI | Titanium 6AL-4V ELI |
| Connection | Internal Hex | Internal Hex |
| Prosthesis Attachment | Screw -or cement retained | Screw -or cement retained |
| Restoration | Single or multi-unit | Single or multi-unit |
| Sterilization | Supplied sterile; Provided sterile | Supplied sterile; Provided sterile |
| Sterilization Method | Gamma Irradiation | Gamma Irradiation |
| SAL | 10^{-6} | 10^{-6} |
| Abutment Material | Titanium 6AL-4V ELI | Titanium 6AL-4V ELI |
| Screw Material | Titanium 6AL-4V ELI | Titanium 6AL-4V ELI |

{23}

510(k) Summary

TriActive Dental Implant System

K261392

Page 19 of 25

| Characteristic | Subject Device: K261392 TriActive Dental Implant System Paragon Implant Mfg, LLC | Predicate Device: K251938 GEN5™ and GEN5+™ Dental Implant System Paragon Implant Mfg, LLC |
| --- | --- | --- |
| **Device** | Extender Healing Abutments & Cover Screws | Extender Healing Abutments & Cover Screws |
| **Usage** | Single Use | Single Use |
| **Screw Size** | M1.6 and M2.0 | 1-72 UNF |
| **Use with Implant Diameters** | 3.2mm; 3.7mm; 4.3mm; 5.0mm; 5.5mm | 3.7mm; 4.2mm; 4.7mm; 5.2mm; 5.7mm |
| **Platform** | 3.0mm; 3.4mm | 3.5mm; 4.5mm; 5.7mm |
| **Extender Collar Height** | 2mm | 2mm |
| **Cover Screw Post Height** | 1mm; 3mm | 1mm; 2mm; 3mm |
| **Finish** | Anodized | Anodized |

# **Extender Abutments:**

| Characteristic | Subject Device: K261392 TriActive Dental Implant System Paragon Implant Mfg, LLC | Predicate Device: K251938 GEN5™ and GEN5+™ Dental Implant System Paragon Implant Mfg, LLC |
| --- | --- | --- |
| **Device** | Extender Abutments | Extender Abutments |
| **Regulation Number** | 21 C.F.R. § 872.3630 (Endosseous dental implant abutment) | 21 C.F.R. § 872.3630 (Endosseous dental implant abutment) |
| **Classification** | Class II | Class II |
| **Primary Product Code** | NHA | NHA |
| **Reason for Predicate/Reference** | N/A | - Similar General Design - Identical Intended Use - Similar Range Diameters: Subject smallest is 3.2mm while predicate is 3.7mm. Subject largest is 5.5mm while predicate is 5.7mm. - Similar Connection Type - Identical Sterilization, Sterilization Method, SAL |

{24}

510(k) Summary

TriActive Dental Implant System

K261392

Page 20 of 25

| Characteristic | Subject Device: K261392 TriActive Dental Implant System Paragon Implant Mfg, LLC | Predicate Device: K251938 GEN5™ and GEN5+™ Dental Implant System Paragon Implant Mfg, LLC |
| --- | --- | --- |
| Device | Extender Abutments | Extender Abutments |
| | | - Identical Usage - Identical Materials - Similar Screw Size: Subject is M1.6 or M2.0 while predicate is 1-72 UNF. - Similar Platform Size - Similar Post Height: Subject & predicate smallest is 1mm. Subject largest is 9mm while predicate is 9.43mm. - Identical finish |
| Indications for Use | TriActive implants are two-piece implants for one- or two-stage surgical procedures. These implants are indicated for use in partially or fully edentulous upper and lower jaws in support of single- or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework. TriActive Implants can be indicated for immediate function when initial implant stability has been achieved and with appropriate occlusal loading. Short (<8.5mmL) TriActive Implants: Indicated for single tooth (mandibular and maxillary central and lateral incisors), multiple tooth replacements or denture stabilization. Narrow (<3.7mmD) TriActive Implants are indicated for single tooth replacement of mandibular central and lateral incisors, and maxillary lateral incisors, or splinted to other dental implants for multi-unit fixed or removable partial prostheses, or for denture stabilization. The TriActive Abutment System is intended for use with TriActive dental implants in the maxillary and/or mandibular arches to provide support for crowns, bridges, or overdentures for edentulous or partially edentulous patients, using traditional crown & bridge techniques. | The GEN5 and GEN5+ Abutment System is intended for use with dental implants in the maxillary and/or mandibular arches to provide support for crowns, bridges, or overdentures for edentulous or partially edentulous patients, using traditional crown & bridge techniques |

{25}

510(k) Summary

TriActive Dental Implant System

K261392

Page 21 of 25

| Characteristic | Subject Device: K261392 TriActive Dental Implant System Paragon Implant Mfg, LLC | Predicate Device: K251938 GEN5™ and GEN5+™ Dental Implant System Paragon Implant Mfg, LLC |
| --- | --- | --- |
| Device | Extender Abutments | Extender Abutments |
| | All digitally designed custom abutments for use with DESS Bases or Blanks are to be sent to a Terrats Medical SL validated milling center for manufacture. The TriActive Implant bodies are indicated for compatibility with the following abutments systems: • Ti-base Abutments manufactured by Terrats Medical SL., platform NP and RP, Straight, max 0 degrees ○ Active Hex • Ti-blank Abutments manufactured by Terrats Medical SL., platform NP and RP, Straight, max 0 degrees ○ Active Hex • CoCr Base Abutments manufactured by Terrats Medical SL., platform NP and RP, Straight, max 0 degrees ○ Active Hex • CoCr Blank Abutments manufactured by Terrats Medical SL., platform NP and RP, Straight, max 0 degrees ○ Active Hex • Angled Multi-Unit Abutments manufactured by Terrats Medical SL., platform NP and RP, Angled, max 30 degrees ○ Active Hex • Stock Straight Abutments manufactured by Terrats Medical SL., platform NP and RP, Straight, max 0 degrees ○ Active Hex • Locator Abutments manufactured by Terrats Medical SL., platform NP and RP, Straight, max 0 degrees ○ Active Hex | |
| Abutment Material | Titanium 6AL-4V ELI | Titanium 6AL-4V ELI |
| Screw Material | Titanium 6AL-4V ELI | Titanium 6AL-4V ELI |
| Connection | Internal Hex | Internal Hex |
| Prosthesis Attachment | Screw -or cement retained | Screw -or cement retained |

{26}

510(k) Summary

TriActive Dental Implant System

K261392

Page 22 of 25

| Characteristic | Subject Device: K261392 TriActive Dental Implant System Paragon Implant Mfg, LLC | Predicate Device: K251938 GEN5™ and GEN5+™ Dental Implant System Paragon Implant Mfg, LLC |
| --- | --- | --- |
| Device | Extender Abutments | Extender Abutments |
| Restoration | Single or multi-unit | Single or multi-unit |
| Sterilization | Sold non-sterile; reprocessed by end user | Sold non-sterile; reprocessed by end user |
| Sterilization Method | N/A | N/A |
| SAL | N/A | N/A |
| Usage | Single Use | Single Use |
| Screw Size | M1.6 and M2.0 | 1-72 UNF |
| Use with Implant Diameters | 3.2mm; 3.7mm; 4.3mm; 5.0mm; 5.5mm | 3.7mm; 4.2mm; 4.7mm; 5.2mm; 5.7mm |
| Platform | 4.8mm | 4.8mm |
| Collar Height | N/A | N/A |
| Post Height | 1mm - 9mm | 1mm - 9.43 |
| Finish: | Anodized | Anodized |

# Extender NizLoc Abutments:

| Characteristic | Subject Device: K261392 TriActive Dental Implant System Paragon Implant Mfg, LLC | Predicate Device: K170588 DESS Dental Smart Solutions Terrats Medical SL |
| --- | --- | --- |
| Device | Extender NizLoc Abutments | DESS LOC Abutments |
| Regulation Number | 21 C.F.R. § 872.3630 (Endosseous dental implant abutment) | 21 C.F.R. § 872.3630 (Endosseous dental implant abutment) |
| Classification | Class II | Class II |
| Primary Product Code | NHA | NHA |
| Reason for Predicate/Reference | N/A | - Similar General Design - Identical Intended Use - Similar Diameters: Subject smallest is 3.2mm while predicate is 3.25mm. Subject largest is 5.5mm while predicate is 6.0mm. - Similar Connection Type - Similar Sterilization, Sterilization Method, and SAL |

{27}

510(k) Summary

TriActive Dental Implant System

K261392

Page 23 of 25

| Characteristic | Subject Device: K261392 TriActive Dental Implant System Paragon Implant Mfg, LLC | Predicate Device: K170588 DESS Dental Smart Solutions Terrats Medical SL |
| --- | --- | --- |
| Device | Extender NizLoc Abutments | DESS LOC Abutments |
| | | - Identical Usage - Similar Materials - Similar Screw Size - Similar Range Platform Size: Subject is 4.8mm while predicate is 3.4mm – 5.7mm. - Similar Range Collar Height: Subject smallest is 0mm while predicate is 1mm. Subject largest is 2mm while predicate is 4mm. - Different Finish: Subject is anodized while predicate is Zirconium Nitride. |
| Indications for Use | TriActive implants are two-piece implants for one- or two-stage surgical procedures. These implants are indicated for use in partially or fully edentulous upper and lower jaws in support of single- or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework. TriActive Implants can be indicated for immediate function when initial implant stability has been achieved and with appropriate occlusal loading. Short (<8.5mmL) TriActive Implants: Indicated for single tooth (mandibular and maxillary central and lateral incisors), multiple tooth replacements or denture stabilization. Narrow (<3.7mmD) TriActive Implants are indicated for single tooth replacement of mandibular central and lateral incisors, and maxillary lateral incisors, or splinted to other dental implants for multi-unit fixed or removable partial prostheses, or for denture stabilization. The TriActive Abutment System is intended for use with TriActive dental implants in the maxillary and/or mandibular arches to provide support for crowns, bridges, or overdentures for edentulous or partially edentulous patients, using traditional crown & bridge techniques. | DESS Dental Smart Solutions abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for prosthetic restorations. |

{28}

510(k) Summary

TriActive Dental Implant System

K261392

Page 24 of 25

| Characteristic | Subject Device: K261392 TriActive Dental Implant System Paragon Implant Mfg, LLC | Predicate Device: K170588 DESS Dental Smart Solutions Terrats Medical SL |
| --- | --- | --- |
| Device | Extender NizLoc Abutments | DESS LOC Abutments |
| | All digitally designed custom abutments for use with DESS Bases or Blanks are to be sent to a Terrats Medical SL validated milling center for manufacture. The TriActive Implant bodies are indicated for compatibility with the following abutments systems: • Ti-base Abutments manufactured by Terrats Medical SL., platform NP and RP, Straight, max 0 degrees ○ Active Hex • Ti-blank Abutments manufactured by Terrats Medical SL., platform NP and RP, Straight, max 0 degrees ○ Active Hex • CoCr Base Abutments manufactured by Terrats Medical SL., platform NP and RP, Straight, max 0 degrees ○ Active Hex • CoCr Blank Abutments manufactured by Terrats Medical SL., platform NP and RP, Straight, max 0 degrees ○ Active Hex • Angled Multi-Unit Abutments manufactured by Terrats Medical SL., platform NP and RP, Angled, max 30 degrees ○ Active Hex • Stock Straight Abutments manufactured by Terrats Medical SL., platform NP and RP, Straight, max 0 degrees ○ Active Hex • Locator Abutments manufactured by Terrats Medical SL., platform NP and RP, Straight, max 0 degrees ○ Active Hex | |
| Material | Titanium 6AL-4V ELI | Titanium 6AL-4V ELI |
| Screw Material | Titanium 6AL-4V ELI | Titanium 6AL-4V ELI |
| Connection | Internal Hex | Internal |
| Prosthesis Attachment | Cement-retained; Screw-retained | Cement-retained; Screw-retained |

{29}

510(k) Summary

TriActive Dental Implant System

K261392

Page 25 of 25

| Characteristic | Subject Device: K261392 TriActive Dental Implant System Paragon Implant Mfg, LLC | Predicate Device: K170588 DESS Dental Smart Solutions Terrats Medical SL |
| --- | --- | --- |
| **Device** | Extender NizLoc Abutments | DESS LOC Abutments |
| **Restoration** | Single-unit; Multi-unit | Single-unit; Multi-unit |
| **Sterilization** | Sold non-sterile; reprocessed by end user | Sold non-sterile; reprocessed by end user |
| **Sterilization Method** | N/A | N/A |
| **SAL** | N/A | N/A |
| **Usage** | Single Use | Single Use |
| **Screw Size** | M1.6; M2.0 | M1.6; M2.0 |
| **Use with Implant Diameters** | 3.2mm; 3.7mm; 4.3mm; 5.0mm; 5.5mm | 3.25mm – 6.0mm |
| **Platform** | 4.8mm | NP and RP: 3.4mm – 5.7mm |
| **Collar Height** | 0mm; 1mm; 2mm | 1mm; 2mm; 3mm; 4mm |
| **Post Height** | N/A | N/A |
| **Finish** | Anodized | Zirconium Nitride |