DESS Dental Smart Solutions

K222269 · Terrats Medical SL · NHA · Oct 26, 2022 · Dental

Device Facts

• Record ID: K222269
• Device Name: DESS Dental Smart Solutions
• Applicant: Terrats Medical SL
• Product Code: NHA · Dental
• Decision Date: Oct 26, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

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

Device Story

DESS Dental Smart Solutions are dental implant abutments used to support prosthetic restorations (crowns, bridges). The system includes Multi Unit Abutments (straight, 17°, 30°), Ti Base and AURUM Base abutments (for CAD-CAM zirconia superstructures), and Premilled Blank Abutments. Inputs include patient-specific anatomical data captured via digital impression/scanning; these are processed at a Terrats Medical validated milling center to fabricate custom abutments or superstructures. The device is used in dental clinics by clinicians; the output is a custom-milled abutment or superstructure that attaches to the endosseous implant via an abutment screw. This provides a functional and esthetic interface for the final dental prosthesis. Benefits include patient-specific fit and restoration support. All components are provided non-sterile and require sterilization by the user.

Clinical Evidence

No clinical data included. Substantial equivalence is supported by bench testing, including static compression and compression fatigue testing per ISO 14801, biocompatibility testing per ISO 10993, and MR environment safety analysis.

Technological Characteristics

Materials: Ti-6Al-4V ELI (ASTM F136), Zirconia (ISO 13356). Surface: SelectGrip sandblasted or gold anodized. Components: Multi Unit, Ti Base, AURUM Base, Premilled Blanks. Connectivity: Compatible with specific OEM internal TiLobe, hex, and conical implant connections. Sterilization: Moist heat (non-sterile provided).

Indications for Use

Indicated for patients requiring prosthetic restoration support in the maxillary or mandibular arch using endosseous dental implants. Compatible with specific internal TiLobe, internal hex, and internal conical connection implant systems.

Regulatory Classification

Identification

An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.

Special Controls

*Classification.* Class II (special controls). 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.)

Predicate Devices

• DESS Dental Smart Solutions (K212628)
• DESS Dental Smart Solutions (K212577)
• DESS Dental Smart Solutions (K173908)

Reference Devices

• Keystone Dental XL Dental Implant System (K201334)
• PrimaConnex Internal Connection Implant System (K051614)
• Restore, Stage-19, Renova, PrimaConnex Dental Implants (K072768)
• Genesis Implant System (K101545)
• Paltop Dental Implant System (K112795)
• Paltop Narrow Implant (K210117)
• Paltop Conical Implant System (K220200)
• Multi-Link cement (K130436)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Terrats Medical SL % Kevin Thomas Vice President & Director of Regulatory Affairs PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, California 92130

Re: K222269

Trade/Device Name: DESS Dental Smart Solutions Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: July 28, 2022 Received: July 28, 2022

Dear Kevin Thomas:

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 (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 located 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.

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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 Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K22269

Device Name

DESS Dental Smart Solutions

#### Indications for Use (Describe)

DESS Dental Smart Solutions abutnents are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for prosthetic restorations.

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

| Compatible Implant System<br>(Connection) | Implant Body Diameter, mm | Implant Platform |
|-------------------------------------------------------|---------------------------|------------------------|
| PRIMA CONNEX<br>(Internal TiLobe, Tapered & Straight) | 3.3, 3.5 | 3.5 |
| | 4.0, 4.1 | 4.1 |
| | 5.0 | 5.0 |
| GENESIS<br>(Internal TiLobe) | 3.5, 3.8 | 3.5/3.8 |
| | 4.5 | 4.5 |
| | 5.5, 6.5 | 5.5/6.5 |
| MOLARIS TILOBEMAXX<br>(Internal TiLobe) | 7 | 5.7 |
| | 8 | 6.5 |
| | 9 | 7.5 |
| MOLARIS I-HEXMRT<br>(Internal Hex) | 7 | 5.7 |
| | 8 | 6.5 |
| | 9 | 7.5 |
| PALTOP ADVANCED CLASSIC<br>(Internal Hex) | 3.25 | NP (3.25) |
| | 3.75, 4.2, 5.0 | SP (3.75/4.2/5.0) |
| PALTOP ADVANCED PLUS<br>(Internal Hex) | 3.0, 3.25 | NP (3.25) |
| | 3.75, 4.2, 5.0 | SP (3.75/4.2/5.0) |
| | 6.0 | WP (6.0) |
| PALTOP DYNAMIC<br>(Internal Hex) | 3.0, 3.25 | NP (3.25) |
| | 3.75, 4.2, 5.0 | SP (3.75/4.2/5.0) |
| | 6.0 | WP (6.0) |
| PALTOP DYNAMIC CONICAL<br>(Internal Conical) | 3.25, 3.75, 4.2, 5.0 | CC (3.25/3.75/4.2/5.0) |

#### Compatible Implant Systems

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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# 510(k) Summary K22269 Terrats Medical SL DESS® Dental Smart Solutions

October 25, 2022

#### ADMINISTRATIVE INFORMATION

| Manufacturer Name | Terrats Medical SL<br>Carrer Mogoda, 75-99<br>08210 Barberà del Vallès<br>Barcelona, Spain |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Telephone | [phone] |
| Official Contact | Roger Terrats, CEO |
| Representative/Consultant | Kevin A. Thomas, PhD<br>Floyd G. Larson, MS, MBA<br>PaxMed International, LLC<br>12264 El Camino Real, Suite 400<br>San Diego, CA 92130<br>Telephone [phone]<br>Fax [phone]<br>Email [e-mail]<br>[e-mail] |

#### DEVICE NAME AND CLASSIFICATION

| Trade/Proprietary Name | DESS Dental Smart Solutions |
|------------------------|---------------------------------------------------------------------------------------------|
| Common Name | Dental implant abutment |
| Regulation Number | 21 CFR 872.3630 |
| Regulation Name | Endosseous dental implant abutment |
| Regulatory Class | Class II |
| Product Code | NHA |
| Classification Panel | Dental |
| Reviewing Office | Office of Health Technology 1 (Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices) |
| Reviewing Division | Division of Dental and ENT Devices |

#### PREDICATE DEVICE INFORMATION

Primary Predicate Device K212628, DESS Dental Smart Solutions, Terrats Medical SL

Reference Devices K212577, DESS Dental Smart Solutions, Terrats Medical SL K191986, DESS Dental Smart Solutions, Terrats Medical SL K173908, DESS Dental Smart Solutions, Terrats Medical SL K201334, Keystone Dental XL Dental Implant System, Keystone Dental, Inc.

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K051614, PrimaConnex™ Internal Connection Implant System, Lifecore Biomedical, Inc. K072768, Restore®, Stage-19, Renova®, PrimaConnex® Dental Implants, Lifecore Biomedical, Inc. K101545, Genesis Implant System, Keystone Dental, Inc. K112795, Paltop Dental Implant System, Paltop Advanced Dental Solutions Ltd. K210117, Paltop Narrow Implant, Paltop Advanced Dental Solutions, Ltd. K220200, Paltop Conical Implant System, Paltop Advanced Dental Solutions, Ltd.

## INDICATIONS FOR USE STATEMENT

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.

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

| Compatible Implant System<br>(Connection) | Implant Body Diameter, mm | Implant Platform |
|-------------------------------------------------------|---------------------------|------------------------|
| PRIMA CONNEX<br>(Internal TiLobe, Tapered & Straight) | 3.3, 3.5 | 3.5 |
| | 4.0, 4.1 | 4.1 |
| | 5.0 | 5.0 |
| GENESIS<br>(Internal TiLobe) | 3.5, 3.8 | 3.5/3.8 |
| | 4.5 | 4.5 |
| | 5.5, 6.5 | 5.5/6.5 |
| MOLARIS TILOBEMAXX<br>(Internal TiLobe) | 7 | 5.7 |
| | 8 | 6.5 |
| | 9 | 7.5 |
| MOLARIS I-HEXMRT<br>(Internal Hex) | 7 | 5.7 |
| | 8 | 6.5 |
| | 9 | 7.5 |
| PALTOP ADVANCED CLASSIC<br>(Internal Hex) | 3.25 | NP (3.25) |
| | 3.75, 4.2, 5.0 | SP (3.75/4.2/5.0) |
| PALTOP ADVANCED PLUS<br>(Internal Hex) | 3.0, 3.25 | NP (3.25) |
| | 3.75, 4.2, 5.0 | SP (3.75/4.2/5.0) |
| | 6.0 | WP (6.0) |
| PALTOP DYNAMIC<br>(Internal Hex) | 3.0, 3.25 | NP (3.25) |
| | 3.75, 4.2, 5.0 | SP (3.75/4.2/5.0) |
| | 6.0 | WP (6.0) |
| PALTOP DYNAMIC CONICAL<br>(Internal Conical) | 3.25, 3.75, 4.2, 5.0 | CC (3.25/3.75/4.2/5.0) |

### Compatible Implant Systems

# SUBJECT DEVICE DESCRIPTION

The purpose of this submission is to add components to the DESS Dental Smart Solutions system, which includes abutments cleared previously in K170588, K173908, K191986, K203464, K212577, and K212628. This submission adds various abutments to eight (8) OEM implant lines from Keystone Dental, Inc., having three (3) implant-abutment connections (Internal TiLobe, Internal Conical). The subject device abutment

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designs include Multi Unit Abutments (straight and angled 17° and 30°), Ti Base abutments, and Premilled Blank Abutments. Abutments are provided with the appropriate abutment screw (if applicable) for attachment to the corresponding implant, and the appropriate prosthetic screw (if applicable) for attachment of a screw-retained prosthesis. All abutments and screws are provided non-sterile.

A summary of the subject device abutment designs and the compatible OEM implants is provided in the table Summary of Subject Device Abutment Designs and Compatible Implants on the following page.

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# Summary of Subject Device Abutment Designs and Compatible Implants

| Connection | Compatible Implant Systems | Implant Body Ø, mm | Implant Platform Ø, mm | Multi Unit<br>Straight and 17° Angled | Multi Unit<br>30° Angled | Subject Device Abutments | | |
|------------------|-----------------------------------------------------------------------------|----------------------|------------------------|---------------------------------------|--------------------------|--------------------------|-------------|------------------|
| | | | | | | Ti Bases | AURUM Bases | Premilled Blanks |
| Internal TiLobe | PRIMA CONNEX<br>(Internal TiLobe, Tapered & Straight)<br>K051614<br>K072768 | 3.3, 3.5 | 3.5 | X | X | X | X | X |
| | 4.0, 4.1 | 4.1 | X | X | X | X | X | |
| | 5.0 | 5.0 | X | X | X | X | X | |
| | GENESIS<br>(Internal TiLobe)<br>K101545 | 3.5, 3.8 | 3.5/3.8 | X | X | X | X | X |
| | 4.5 | 4.5 | X | X | X | X | X | |
| | 5.5, 6.5 | 5.5/6.5 | X | X | X | X | X | |
| | MOLARIS TILOBEMAXX<br>(Internal TiLobe)<br>K201334 | 7 | 5.7 | X | | X | | X |
| | 8 | 6.5 | X | | X | | X | |
| | 9 | 7.5 | X | | X | | X | |
| | MOLARIS I-HEXMRT<br>(Internal Hex)<br>K201334 | 7 | 5.7 | X | | X | | X |
| | 8 | 6.5 | X | | X | | X | |
| | 9 | 7.5 | X | | X | | X | |
| Internal Hex | PALTOP ADVANCED CLASSIC<br>(Internal Hex)<br>K112795 | 3.25 | NP (3.25) | X | | X | X | X |
| | 3.75, 4.2, 5.0 | SP (3.75/4.2/5.0) | X | X | X | X | X | |
| | PALTOP ADVANCED PLUS<br>(Internal Hex)<br>K210117 | 3.0, 3.25 | NP (3.25) | X | | X | X | X |
| | 3.75, 4.2, 5.0 | SP (3.75/4.2/5.0) | X | X | X | X | X | |
| | 6.0 | WP (6.0) | X | | X | X | X | |
| | PALTOP DYNAMIC<br>(Internal Hex)<br>K112795 | 3.0, 3.25 | NP (3.25) | X | | X | X | X |
| | 3.75, 4.2, 5.0 | SP (3.75/4.2/5.0) | X | X | X | X | X | |
| | 6.0 | WP (6.0) | X | | X | X | X | |
| Internal Conical | PALTOP DYNAMIC CONICAL<br>(Internal Conical)<br>K220200 | 3.25, 3.75, 4.2, 5.0 | CC (3.25/3.75/4.2/5.0) | X | X | X | X | X |

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The design dimensions and tolerances of subject device abutments and screws have been established on the basis of a contractual agreement and working relationship between Keystone Dental, Inc., and Terrats Medical SL to ensure that the abutments are designed to fit the corresponding Keystone Dental implants listed above.

### Multi Unit Abutments

The Multi Unit Abutment is designed for attachment of multi-unit screw-retained restorations and is provided in three (3) designs, straight, angled 17°, and angled 30°. The straight Multi Unit Abutment is provided only in a non-engaging, threaded design that attaches directly to the implant, with a prosthetic platform diameter of 4.8 mm or 6.0 mm, and with a gingival height ranging from 1 mm to 5 mm. Straight Multi Unit Abutments are provided for all eight (8) compatible OEM implant lines. The angled Multi Unit Abutments are provided only in an engaging design that requires an abutment screw, with a prosthetic platform diameter of 4.8 mm, and with a gingival height ranging from 2.5 mm. The Multi Unit Abutments angled 30° are provided with a prosthetic platform diameter of 4.8 mm, and with a gingival height ranging from 3 mm to 5 mm. The Multi Unit Abutments angled 17° are provided for all eight (8) compatible OEM implant lines, and the Multi Unit Abutments angled 30° are provided for six (6) compatible OEM implant lines.

### Ti Base and AURUM Base Abutments

Ti Base and AURUM Base abutments are designed for patient-specific abutment fabrication of a CAD-CAM zirconia superstructure on which a crown may be placed. They also may be used for support of a crown placed directly on the abutment. The cement recommended for bonding of superstructures is Multi-Link cement by Ivoclar Vivadent (K130436). All patient-specific abutment fabrication for Ti Base and AURUM Base abutments is by prescription on the order of the clinician. All zirconia superstructures for use with the subject device Ti Base and AURUM Base abutments will be made at a Terrats Medical milling center under FDA quality system regulations, and the material will conform to ISO 13356.

The Ti Bases and AURUM Bases are used as part of a two piece abutment. where the base is premanufactured from titanium alloy (Ti-6Al-4V ELI) and the top half is a CAD-CAM zirconia superstructure, milled at a validated milling center. These pieces are cemented together to form the final abutment.

Ti Base abutments are provided in engaging design and non-engaging designs for all eight (8) compatible OEM implant lines. Ti Base abutments are provided with a prosthetic platform diameter ranging from 4.1 mm to 7.0 mm, and a gingival height ranging from 1 mm to 3 mm. The prosthetic post height is 4.2 mm for all Ti Base abutments. Ti Base Abutments are manufactured from titanium alloy with a sandblasted surface treatment process (SelectGrip®) to aid in bonding retention of a cemented prosthesis. When used for a direct crown, Ti Base Interface may be used with a POM burn out sleeve, an exempt laboratory component not a subject of this submission, that is available for laboratory fabrication of the prosthesis.

The design parameters for the CAD-CAM zirconia superstructure, or traditional laboratory fabrication such as precious or non-precious cast, to be used on Ti Base Abutments are:

Minimum wall thickness – 0.4 mm

Minimum post height for single-unit restoration - 4.2 mm

Minimum gingival height - 0.5 mm

Maximum gingival height - 6.0 mm

All zirconia superstructures and PFM crowns for use with the titanium bases are for straight restorations only.

AURUM Base Abutments are provided in engaging design and non-engaging designs for six (6) compatible OEM implant lines. The design of the AURUM Base allows for easier instrument access to the abutment screw (up to 25° of instrument angulation) and allows for placement of the screw channel out of the esthetic region of the restoration. AURUM Base abutments are provided with a prosthetic platform diameter ranging from 4.1 mm to 6.0 mm, and a gingival height of 1 mm. Before attachment of the zirconia superstructure or crown, the AURUM

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Base prosthetic post height is 3.0 mm. When used for a single-unit restoration the AURUM Base is to be used with a superstructure to create a minimum post height of 4.0 mm.

AURUM Base Abutments are manufactured from titanium alloy (Ti-6A1-4V) and are colored gold by an anodization process in which the abutment is submerged in an electrolytic solution and exposed to an electric current to achieve the gold color.

The design parameters for the CAD-CAM zirconia superstructure, or traditional laboratory fabrication such as precious or non-precious cast, to be used on AURUM Base Abutments are:

Minimum wall thickness – 0.4 mm Minimum post height for single-unit restoration – 4.0 mm Minimum gingival height - 0.5 mm Maximum gingival height - 6.0 mm All zirconia superstructures and PFM crowns for use with the AURUM bases are for straight restorations only.

### Premilled Blank Abutments

Premilled Blank Abutments are available in engaging designs only, for all eight (8) compatible OEM implant lines. All patient-specific abutment fabrication of Premilled Blank Abutments is by prescription on the order of the clinician, and will be done at a Terrats Medical validated milling center under FDA quality system regulations. The Premilled Blank Abutments have a maximum (before milling) diameter of 10 mm or 14 mm.

The design parameters for the CAD-CAM fabrication of patient-specific abutments from Premilled Blank Abutments are:

Minimum wall thickness - 0.45 mm Minimum post height for single-unit restoration - 4.0 mm Minimum gingival height - 0.5 mm Maximum gingival height - 6.0 mm Pre-Milled Blanks are for straight abutments only

#### Screws

This submission includes ten (10) abutment screws to be used with the subject device abutments, and seven (7) prosthetic screws to be used with the subject device Multi Unit abutments. The screws have hex, hexalobular, or square drive instrument interfaces and are manufactured from titanium alloy (Ti-6Al-4V) with the Diamond-like Carbon (DLC) coating.

### MATERIAL COMPOSITION

All subject device abutments, abutment screws, and prosthetic screws are manufactured from Ti-6A1-4V alloy conforming to ASTM F136. Abutment screws and prosthetic screws manufactured from ASTM F136 titanium alloy and coated with Diamond-like carbon (DLC) are provided to attach the abutments to the implant and to attach the attach the restoration to the abutment. The titanium alloy and DLC coating are identical to the material and coating used to manufacture DESS Dental Smart Solutions screws cleared in K212628, K212577, and K173908.

Ti Base Abutments have a sandblasted surface finish (SelectGrip®). This surface is identical to the surface used on DESS Dental Smart Solutions components cleared in K212628. The anodization process used for the subject AURUM Abutments is identical to the anodization treatment used to manufacture DESS Aurum Abutments cleared in K212628 and K173908.

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All superstructures for use with the CAD-CAM abutments (Ti Bases and AURUM Bases) will be manufactured from zirconia conforming to ISO 13356. This material is identical to the zirconia material to be used to manufacture superstructures for DESS Dental Smart Solutions components cleared in K212628 and K173908.

## PERFORMANCE DATA

Non-clinical data submitted, referenced, or relied upon to demonstrate substantial equivalence included:

sterilization validation according to ISO 17665-1 and ISO 17665-2, referenced from K212628;

biocompatibility according to ISO 10993-5 and ISO 10993-12. referenced from K212628;

non-clinical analysis performed to evaluate the metallic subject devices in the MR environment using scientific rationale and published literature (TO Woods, JG Delfino, "Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices," Journal of Testing and Evaluation, Volume 49, No. 2, 2021, pp. 783-795); the analysis addressed parameters per the FDA guidance Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment (issued May 2021) including magnetically induced displacement force and torque; and

static compression and compression fatigue testing of worst-case constructs comprising the subject device Multi Unit Angled Abutments and compatible OEM implants in conformance with ISO 14801.

No clinical data were included in this submission.

# EQUIVALENCE TO MARKETED DEVICES

The subject device abutments are substantially equivalent in intended use to the primary predicate device cleared in K212628 and the additional predicate devices cleared in 212577 and K173908. All are intended for use with endosseous dental implants in the maxilla and mandible to provide functional and esthetic rehabilitation of the edentulous maxilla and mandible. The Indications for Use Statement (IFUS) for the subject device is substantially equivalent to that of K212628, K212577, and K173908, except for the list of compatible OEM implants.

Differences between the subject device IFUS and that of the additional predicate K201334 include additional language in K201334 describing the use of the dental implants that is not applicable to the subject device abutments. The IFUS for K201334 does include language regarding support of dental prostheses that is similar to that of the subject device.

All subject device abutments are similar or identical in design, materials and technological characteristics to corresponding abutments of the primary predicate device K212628 and the additional predicate devices K212577, and K173908. In some cases, the abutments vary slightly from the subject device to the previous submissions (K212628, K212577, and K173908).

The SelectGrip® surface on the subject device Ti Base Abutments is identical to the Select Grip® surface on equivalent abutments cleared in K212628 and K173908. The gold anodized surface on the subject device AURUM Base Abutments is identical to the anodized surface on Aurum Abutments of the predicate devices K212628 and K173908.

The cement recommended in labeling for bonding of superstructures is Multi-Link cement from Ivoclar Vivadent, cleared under K130436. This is the same cement recommended in labeling for the primary predicate device K212628 and the additional predicate device K173908.

All screws are identical in design, materials and technological characteristics to those cleared in predicate devices K212628, K212577, and K173908, except for threads and lengths that accommodate the new compatibilities. The

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510(k) Summary Page 8 of 14

Diamond-like carbon (DLC) coating applied to all screws is identical to the DLC coating on screws cleared in K212628, K212577, and K173908.

The range of dimensions of the subject device abutments are encompassed by the corresponding predicate devices. including the abutment-implant platform diameter, prosthetic platform diameter, gingival height, and abutment angulation. The additional predicate device K212577 includes Premilled Blank abutments designs with up to 30° of angulation, which is the maximum angulation of the subject Multi Unit Abutments. The additional predicate device K201334, in addition to the implant compatibilities, is for substantial equivalence of the implantabutment platform diameter (up to 7.5 mm) and abutment prosthetic platform diameter (up to 7 mm).

All subject device components are provided non-sterile and are to be sterilized by the same moist heat cycle recommended in the predicate submissions K212628, K212577, and K173908. The subject devices are packaged in either a PETG blister pack or a PET bag, the same packaging as cleared in K212628, K212577, and K173908.

The risks associated with use of the subject device Angled Multi Unit Abutments in combination with the compatible implants are mitigated by the mechanical testing provided in Section 18 Performance Testing -Bench.

### CONCLUSION

The subject device, the primary predicate device, and the additional predicate devices have intended use, have similar technological characteristics, and are materials. The subject device, the primary predicate, and additional predicate devices encompass the same range of physical dimensions, are packaged in similar materials, and are to be sterilized using similar methods. The data included in this submission demonstrate substantial equivalence to the predicate devices listed above.

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| Table of Substantial Equivalence - Indications for Use Statement | |
|------------------------------------------------------------------|--|
|------------------------------------------------------------------|--|

| Subject Device | Indications for Use Statement | | |
|----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|-----------------------|
| DESS Dental Smart<br>Solutions<br><br>Terrats Medical SL | DESS Dental Smart Solutions abutments are intended to be used in conjunction with endosseous dental<br>implants in the maxillary or mandibular arch to provide support for prosthetic restorations.<br><br>All digitally designed custom abutments for use with DESS Bases or Blanks are to be sent to a Terrats<br>Medical validated milling center for manufacture. | | |
| <b>Compatible Implant Systems</b> | | | |
| Compatible Implant System<br>(Connection) | Implant Body Diameter, mm | Implant Platform | |
| PRIMA CONNEX<br>(Internal TiLobe, Tapered & Straight) | 3.3, 3.5 | 3.5 | |
| | 4.0, 4.1 | 4.1 | |
| | 5.0 | 5.0 | |
| GENESIS<br>(Internal TiLobe) | 3.5, 3.8 | 3.5/3.8 | |
| | 4.5 | 4.5 | |
| | 5.5, 6.5 | 5.5/6.5 | |
| MOLARIS TILOBEMAXX<br>(Internal TiLobe) | 7 | 5.7 | |
| | 8 | 6.5 | |
| | 9 | 7.5 | |
| MOLARIS I-HEXMRT<br>(Internal Hex) | 7 | 5.7 | |
| | 8 | 6.5 | |
| | 9 | 7.5 | |
| PALTOP ADVANCED CLASSIC<br>(Internal Hex) | 3.25 | NP (3.25) | |
| | 3.75, 4.2, 5.0 | SP (3.75/4.2/5.0) | |
| PALTOP ADVANCED PLUS<br>(Internal Hex) | 3.0, 3.25 | NP (3.25) | |
| | 3.75, 4.2, 5.0 | SP (3.75/4.2/5.0) | |
| | 6.0 | WP (6.0) | |
| PALTOP DYNAMIC<br>(Internal Hex) | 3.0, 3.25 | NP (3.25) | |
| | 3.75, 4.2, 5.0 | SP (3.75/4.2/5.0) | |
| | 6.0 | WP (6.0) | |
| PALTOP DYNAMIC CONICAL<br>(Internal Conical) | 3.25, 3.75, 4.2, 5.0 | CC (3.25/3.75/4.2/5.0) | |
| Primary Predicate<br>Device<br>K212628 | DESS Dental Smart Solutions abutments are intended to be used in conjunction with endosseous dental<br>implants in the maxillary or mandibular arch to provide support for prosthetic restorations. | | |
| | All digitally designed custom abutments for use with DESS Bases or Blanks are to be sent to a Terrats<br>Medical validated milling center for manufacture. | | |
| DESS Dental Smart<br>Solutions | Compatible Implant Systems | | |
| Terrats Medical SL | Compatible Implant System | Implant Body Diameter, mm | Implant Platform Name |
| | | 3.0 | 3.0 |
| | | 3.6 | 3.6 |
| | Astra Tech EV | 4.2 | 4.2 |
| | | 4.8 | 4.8 |
| | | 5.4 | 5.4 |
| | | 3.0 | 3.0 |
| | Astra Tech OsseoSpeed™ | 3.5/4.0 | 3.5/4.0 |
| | | 4.5/5.0 | 4.5/5.0 |
| | | 3.0, 3.4, 3.8 | 3.0 |
| | BioHorizons | 3.8, 4.6 | 3.5 |
| | | 4.6, 5.8 | 4.5 |
| | | 5.8 | 5.7 |
| | | 3.25 | 3.4 |
| | Biomet 3i Certain® | 4.0 | 4.1 |
| | | 5.0 | 5.0 |
| | | 3.25 | 3.4 |
| | Biomet 3i OSSEOTITE® | 3.75, 4.0 | 4.1 |
| | | 5.0 | 5.0 |
| | | 3.8 | 3.8 |
| | Camlog | 4.3 | 4.3 |
| | | 5.0 | 5.0 |
| | | 3.8 | 3.8 |
| | FRIADENT XIVE® | 4.5 | 4.5 |
| | | 5.5 | 5.5 |
| | Neodent Grand Morse | 3.5, 3.75, 4.0, 4.3, 5.0, 6.0, 7.0 | Grand Morse (GM) |
| | NobelActive®, NobelParallel<br>Conical | 3.0 | 3.0 |
| | | 3.5 | NP |
| | | 4.3, 5.0 | RP |
| | | 4.3 | RP |
| | NobelReplace® Trilobe | 5.0 | WP |
| | | 6.0 | 6.0 |
| | | 3.3 | NP |
| | Nobel Brånemark System® | 3.75, 4.0 | RP |
| | | 3.5 | Mini |
| | Osstem TS | 4.0, 4.5, 5.0, 6.0, 7.0 | Regular |
| | | 3.5, 3.75, 4.0, 4.5 | RB |
| | Straumann BLX | 5.0, 5.5, 6.5 | WB |
| | | 3.3 | NC |
| | Straumann® Bone Level | 4.1/4.8 | RC |
| | Straumann® Tissue Level | 3.3 | NNC |
| | | 3.3, 3.7, 4.1 | 3.5 |
| | Zimmer Screw Vent®/ Tapered<br>Screw-Vent® | 4.7 | 4.5 |
| | | 6.0 | 5.7 |

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#### 510(k) Summary Page 10 of 14

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| K212577 | | DESS Dental Smart Solutions abutments are intended to be used in conjunction with endosseous dental<br>implants in the maxillary or mandibular arch to provide support for prosthetic restorations. | | | | |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|--|--|--|
| DESS Dental Smart<br>Solutions | All digitally designed custom abutments for use with Pre-milled Blank are to be sent to a Terrats Medical<br>validated milling center for manufacture. | | | | | |
| | | Compatible Implant Systems | | | | |
| Terrats Medical SL | Compatible Implant System | Implant Body Diameter, mm | Implant Platform | | | |
| | NobelActive®, NobelParallel | 3.5 | NP | | | |
| | Conical | 4.3, 5.0<br>ર .5 | RP<br>WP | | | |
| | | 3.3 | NC | | | |
| | Straumann® Bone Level | 4.1/4.8 | RC | | | |
| | | 3.7, 4.1 | 3.5 | | | |
| | Zimmer Screw-Vent® / Tapered | 4.7 | 4.5 | | | |
| | Screw-Vent® | 6.0 | 5.7 | | | |
| Reference Device | | DESS Dental Smart Solutions abutments are intended to be used in conjunction with endosseous dental | | | | |
| K173908 | | implants in the maxillary or mandibular arch to provide support for prosthetic restorations. | | | | |
| | | All digitally designed custom abutments for use with Aurum™ Abutment or Pre-milled Blank are to be sent to | | | | |
| DESS Dental Smart<br>Solutions | a Terrats Medical validated milling center for manufacture. | Compatible Implant Systems | | | | |
| Terrats Medical SL | Implant System Compatibility | Implant Body | Implant Platform | | | |
| | 3i Certain® | 3.25, 4.0, 5.0 | 3.4, 4.1, 5.0 | | | |
| | 3i OSSEOTITE® | 3.25, 3.75, 4.0, 5.0 | 3.4, 4.1, 5.0 | | | |
| | OsseoSpeed™ | 3.5, 4.0, 5.0…