Genesis ACTIVE Implant System

K223814 · Keystone Dental, Inc. · DZE · May 25, 2023 · Dental

Device Facts

• Record ID: K223814
• Device Name: Genesis ACTIVE Implant System
• Applicant: Keystone Dental, Inc.
• Product Code: DZE · Dental
• Decision Date: May 25, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Genesis ACTIVE Implant System is intended for use in single-stage or two-stage surgical procedures for replacing single or multiple missing teeth in partially or fully edentulous mandibles and maxillae. The Genesis ACTIVE Implant System supports single or multiple-unit restorations to re-establish patient chewing function and esthetics. Genesis ACTIVE implants are intended for placement following natural tooth loss or for immediate placement into an extraction socket. Immediate function may be achieved when good primary stability is established, and appropriate occlusal loading is applied. All digitally designed custom abutments for use with Genesis ACTIVE Implants are to be sent to a Keystone Dental validated milling center for manufacture. The KDG-Osteon Precision Milled Suprastructure is indicated for attachment to the Genesis ACTIVE Multi-Unit abutments in the treatment of partially or fully edentulous jaws for the purpose of restoring chewing function. The KDG-Osteon Precision Milled Suprastructure is intended for attachment to a minimum of two (2) abutments.

Device Story

Genesis ACTIVE Implant System comprises endosseous root-form titanium implants, abutments, and accessories for dental restoration. Implants are surgically placed in the mandible or maxilla to support prosthetic teeth. System includes various abutment types (healing, straight, angled, multi-unit, PEEK temporary, titanium base) and CAD/CAM-milled suprastructures. Used by clinicians in dental clinics. Implants provide a foundation for screw-retained or cement-retained prostheses. System restores chewing function and esthetics. Digitally designed custom abutments require manufacturing at a validated milling center. Benefits include immediate function capability when primary stability is achieved.

Clinical Evidence

No clinical data were included in this submission. Substantial equivalence is supported by non-clinical bench testing, including ISO 14801 fatigue testing on worst-case constructs, ISO 10993-1 biological evaluation, ISO 10993-5 cytotoxicity testing, USP<85> endotoxin testing, and sterilization validations (ISO 11137, ISO 17665).

Technological Characteristics

Implants: CP-4 Titanium (ASTM F67, ISO 5832-2), BioSpark/AnaTite surface. Abutments/Screws: Ti-6Al-4V ELI (ASTM F136), PEEK, Yttrium Stabilized Zirconia (ISO 13356). Connection: Internal hex with conical taper. Sterilization: Gamma irradiation (sterile components) or steam (non-sterile/modified). CAD/CAM manufacturing for custom components.

Indications for Use

Indicated for partially or fully edentulous adult patients requiring single or multiple tooth replacement in the mandible or maxilla. Suitable for immediate placement in extraction sockets or following natural tooth loss. Contraindicated if primary stability cannot be achieved.

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

• Genesis Implant System (K101545)

Reference Devices

• Paltop Conical Implant System (K220200)
• Paltop Narrow Implant (K210117)
• TAV Medical Dental Implant System (K170131)
• DESS Dental Smart Solutions (K222269)
• Osteon Precision Milled Suprastructure (K221019)
• Multilink Hybrid Abutment Cement (K130436)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Keystone Dental Inc. Nancy DeAngelo Regulatory Affairs Manager 154 Middlesex Turnpike Burlington, Massachusetts 01803

Re: K223814

Trade/Device Name: Genesis ACTIVE Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: April 25, 2023 Received: April 26, 2023

Dear Nancy DeAngelo:

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 mediation-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 -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 Ouality Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known)

K223814

Device Name Genesis ACTIVE Implant System

#### Indications for Use (Describe)

The Genesis ACTVE Implant System is intended for use in single-stage or two-stage surgical procedures for replacing single or multiple missing teeth in partially or fully edentulous mandibles. The Genesis ACTVE Implant System supports single or multiple-unit restorations to re-establish patient chewing function and esthetics. Genesis ACTIVE implants are intended for placement following natural tooth loss or for immediate placement into an extraction socket. Immediate function may be achieved when good primary stablished, and appropriate occlusal loading is applied.

All digitally designed custom abutments for use with Genesis AC7VE Implants are to be sent to a Keystone Dental validated milling center for manufacture.

The KDG-Osteon Precision Milled Suprastructure is indicated for attachment to the Genesis ACTIVE Multi-Unit abutments in the treatment of partially or fully edentulous jaws for the purpose of restoring chewing function. The KDG-Osteon Precision Milled Suprastructure is intended for attachment to a minimum of two (2) abutments.

| Type of Use (Select one or both, as applicable) |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="text-decoration: overline;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> <span> <span style="text-decoration: overline;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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#### 510(k) Summary Keystone Dental Inc. Genesis ACTIVE Implant System

#### ADMINISTRATIVE INFORMATION

| Manufacturer Name | Keystone Dental Inc.<br>154 Middlesex Turnpike<br>Burlington, MA 01803 |
|--------------------|-------------------------------------------------------------------------------------------------------------------|
| Telephone:<br>Fax: | [phone]<br>[phone] |
| Official Contact | Nancy DeAngelo, Regulatory Affairs Manager<br>Email: [e-mail]<br>Telephone: +(1) 978 436-1784 |

Date submitted: 05/24/2023

#### DEVICE NAME AND CLASSIFICATION

| Trade/Proprietary Name: | Genesis ACTIVE Implant System |
|---------------------------|----------------------------------------------------------------------------------------------|
| Common Name: | Implant, Dental, Endosseous, Root-Form |
| Classification Name: | Endosseous dental implant |
| Classification Regulation | 21 CFR 872.3640 |
| Device Class: | Class II |
| Product Code: | DZE, NHA |
| Review Panel: | Dental |
| Reviewing Branch: | Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)<br>Dental Devices (DHT1B) |

#### PREDICATE DEVICE INFORMATION

The devices within this submission are substantially equivalent in indications, intended use and design principles to the following legally marketed predicate device:

| 510(k) | Predicate Device Name | Company Name |
|---------|----------------------------------------|--------------------------------------------|
| K101545 | Genesis Implant System | Keystone Dental Inc. |
| 510(k) | Reference Device Name | Company Name |
| K220200 | Paltop Conical Implant System | Paltop Advanced Dental Solutions |
| K210117 | Paltop Narrow Implant | Paltop Advanced Dental Solutions |
| K170131 | TAV Medical Dental Implant System | TAV Medical Ltd. |
| K222269 | DESS Dental Smart Solutions | Terrats Medical SL |
| K221019 | Osteon Precision Milled Suprastructure | Implant Solutions PTY LTD (Osteon Medical) |
| K130436 | Multilink Hybrid Abutment Cement | Ivoclar Vivadent AG |

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#### DEVICE DESCRIPTION

The purpose of this submission is for the marketing clearance for the Genesis ACTIVE Implant System which comprises endosseous root-form dental implants, mating compatible abutments, abutment screws, and other associated components for single-unit, multi-unit, and overdenture restorations.

Endosseous dental implants are surgically implanted into a patient's mouth to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. Endosseous dental implant abutments are secured to dental implants with a retaining screw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. Prosthetic devices used with the dental implant abutments in this submission may be screw-retained or cement-retained.

The Genesis ACTIVE Implant System includes endosseous screw type dental implants which can be used in either single- or two-stage surgeries with associated compatible abutments, screws, and other associated accessory components. The Genesis ACTIVE Implant System includes eleven (11) compatible implant abutment designs: Healing Abutments, Straight, Angled Multi-Unit, Angled Multi-Unit, PEEK Straight Temporary, PEEK Angled Temporary, Temporary Cylinder, Titanium Temporary Immediate, Titanium Blank. There are four minor variations of the Titanium Base design: Ti-Base, ANGLEBase®, C-Base®, and ELLIPTIBase®. Prosthetic devices used with the dental implant abutments in this submission may be screw-retained or cemented.

The KDG-Osteon Precision Milled Suprastructure is an overdenture bar which is compatible with the Subject device Multi-Unit abutments. The overdenture bar is a dental restorative device that is intended for screw-retained attachment to dental abutments to aid in the treatment of partial or totally edentulous patients for the purpose of restoring their chewing function. The KDG-Osteon Precision Milled Suprastructure is fabricated by means of CAD/CAM technology by a Keystone Dental Group company and is used to facilitate the attachment of both fixed and removable prostheses.

Subject device implants are manufactured from Commercially Pure (CP) – Grade 4 titanium conforming to ISO 5832-2, Implants for surgery — Metallic materials — Part 2: Unalloyed titanium and ASTM F67, Standard Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50550, UNS R50700). They are anodized pink (AnaTite™) to provide a pink color and have the BioSpark™ surface treatment which results in a hydrophilic surface enriched with calcium and phosphorous ions.

All titanium Subject device abutments, accessories and screws are manufactured from titanium alloy conforming to ASTM F136, Standard Specification for Wrought Titanium-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R5640). Except for the Titanium Blank abutment design, all titanium Subject device abutments are anodized pink. Post surfaces of select abutments receive a media blasting treatment referred to as AnaTite™ or TiPink.

Subject device PEEK temporary abutments are fabricated from PEEK (PolyEther Ether Ketone) material.

All implants and prosthetic components are one-time use devices. All Subject device components are provided sterile and sterilized by gamma irradiation, except for Titanium Blank abutments and the KDG-Osteon Precision Milled Suprastructure which are provided non-sterile. Devices provided non-sterile or modified are sterilized by steam.

| Implant<br>Type | Implant Body<br>Diameter (mm) | Implant Platform<br>Diameter (mm) | Lengths (mm) |
|-------------------|-------------------------------|-----------------------------------|-----------------------|
| Genesis<br>ACTIVE | Ø 3.5 | Ø 3.2 | 10, 11.5, 13, 16 |
| | Ø 3.8 | Ø 3.2 | 8.5, 10, 11.5, 13, 16 |
| | Ø 4.5 | Ø 3.2 | 8.5, 10, 11.5, 13, 16 |
| | Ø 5.5 | Ø 3.2 | 8.5, 10, 11.5, 13 |

#### Genesis ACTIVF Implant System - Implant Sizes

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| Implant<br>Diameter | Healing<br>Abutments | Straight | 20° Angled | Straight<br>Multi-Unit | Angled<br>Multi-Unit | PEEK<br>Temporary | PEEK<br>Angled<br>Temporary | Titanium<br>Temporary | Immediate<br>Temporary | Titanium Base<br>Ti-Base<br>ANGLEBase® | Titanium Base<br>C-Base®<br>ELLIPTIBase® | PreMilled<br>Titanium<br>Blank |
|---------------------|----------------------|------------------------------------|---------------------------------|------------------------|----------------------|-------------------------|-----------------------------|-------------------------|------------------------|----------------------------------------|------------------------------------------|--------------------------------|
| 3.5 | X | X | X | X | X | X | X | X | X | X | X | X |
| 3.8 | X | X | X | X | X | X | X | X | X | X | X | X |
| 4.5 | X | X | X | X | X | X | X | X | X | X | X | X |
| 5.5 | X | X | X | X | X | X | X | X | X | X | X | X |
| Connection | Non-indexed | Indexed | Indexed | Non-Indexed | Indexed | Indexed,<br>Non-Indexed | Indexed | Indexed,<br>Non-Indexed | Non-Indexed | Indexed,<br>Non-Indexed | Indexed | Indexed |
| Material | Ti 6AL-4V ELI | Ti 6AL-4V ELI | Ti 6AL-4V ELI | Ti 6AL-4V ELI | Ti 6AL-4V ELI | PEEK | PEEK | Ti 6AL-4V ELI | Ti 6AL-4V ELI<br>PEEK | Ti 6AL-4V ELI | Ti 6AL-4V ELI | Ti 6AL-4V ELI |
| Finish | AnaTite™ | AnaTite™,<br>SelectGrip® (Terrats) | AnaTite™, SelectGrip® (Terrats) | AnaTite™ | AnaTite™ | None | None | AnaTite™ | AnaTite™ | AnaTite™,<br>SelectGrip® (Terrats) | AnaTite™, SelectGrip® (Terrats) | None |
| Supplied<br>Sterile | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes | No |

#### Genesis ACTIVE Implant System - Abutment Types

#### INDICATIONS FOR USE

The Genesis ACTIVE Implant System is intended for use in single-stage or two-stage surgical procedures for replacing single or multiple missing teeth in partially or fully edentulous mandibles and maxillae. The Genesis ACTIVE Implant System supports single or multiple-unit restorations to re-establish patient chewing function and esthetics. Genesis ACTIVE implants are intended for placement following natural tooth loss or for immediate placement into an extraction socket. Immediate function may be achieved when good primary stability is established, and appropriate occlusal loading is applied.

All digitally designed custom abutments for use with Genesis ACTIVE Implants are to be sent to a Keystone Dental validated milling center for manufacture.

The KDG-Osteon Precision Milled Suprastructure is indicated for attachment to the Genesis ACTIVE Multi-Unit abutments in the treatment of partially or fully edentulous jaws for the purpose of restoring chewing function. The KDG-Osteon Precision Milled Suprastructure is intended for attachment to a minimum of two (2) abutments.

#### EQUIVALENCE TO MARKETED DEVICE

Substantial equivalence is claimed with the Predicate devices are being used to support the expansion of technologies which differ between the Subject and Predicate devices. Provided at the end of this section is a table which compares the Indications for Use Statements and additional tables comparing the technological characteristics of the Subject, Predicate and Reference devices.

#### Indications for Use Statement (IFUS)

The Subject, Predicate and Reference devices have highly similar Indications for Use, differing primarily in device name and the paragraph stating that digitally designed abutments are to be sent to a Keystone Dental validated milling center for manufacture. Digitally designed abutments are included in the K22269 Reference device IFU. The Subject device Indications for Use Statement combines the relevant features of both Predicate and Reference device IFUS as the Subject device includes both traditional and digitally designed dental implant abutments. The Subject and the sponsor's K221019 Reference devices have similar wording regarding the use of the bar Suprastructure, differing only in the list of compatible implant/abutment systems. These minor differences do not raise new questions of safety or effectiveness as all the Indications for Use Statements express equivalent intended use.

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## Technological Characteristics

#### Implants

Overall, the Subject device implants are highly similar to the Predicate and Reference device device implant material and surface treatment is the same as the sponsor's Predicate device. Implant diameters and lengths are supported by the Predicate and K220200 Reference devices. The range of Subject device implant diameters are supported by the Predicate and Reference device implants are single-use, single user, the same as the Predicate device. The slight changes in implant thread design and the implant/abutment interface connection does not affect substantial equivalence nor change the intended use of the devices. Differences in the implant/abutment connections between the Subject and Reference devices do not change the intended use and have been mitigated through non-clinical bench performance testing. Sterilization and packaging of the sterile Subject device implants and screws are the K220200 Reference device. The surface treatment blast media and biocompatibility of the Subject implants is highly similar to the K210117 Reference device.

#### Abutments

Overall, the Subject device abutments are highly similar to the Predicate and Reference devices. Abutment designs are the same in principle, to the Predicate and Reference devices. Critical abutment dimensions, such as the Gingival Height, Prosthetic Diameter, Post Correction Angle, and Post Heights are highly similar between the Subject, Predicate and Reference device abutment designs. Subject device abutments and screws are fabricated from the same materials as the Predicate device and include the same surface treatments as Predicate and Reference devices. Sterilization and packaging of the sterile Subject device abutments and screws are the same as the Predicate device. Cleaning and sterilization of non-sterile Subject device abutments are the Sponsor's K220200 Reference device.

#### Cover Screws

The Subject device Cover Screws are highly similar, combining the platform diameters of the Predicate and K220200 Reference Cover Screws.

#### Healing Abutments

The Subject device Healing Abutments are highly similar to the Predicate and K220200 Reference device Healing Abutments, with only slight differences in gingival height and prosthetic diameter dimensions, and the implant connection.

#### Straight Abutments

The Subject device Straight Abutments are highly similar to the Predicate and K220200 Reference device Straight Abutments, with only slight differences in gingival height, prosthetic diameter and post height dimensions, and implant connection.

#### Angled Abutments

The Subject device Angled Abutments are highly similar to the Predicate and K220200 Reference device Angled Abutments, with only slight differences in gingival height, prosthetic diameter and post height dimensions, and implant connection.

#### Straight PEEK Temporary Abutments

The Subject device Aesthetic Straight PEEK Abutments are similar to the Predicate device straight Esthetic Contour Titanium Abutments but are made from PEEK. The Subject device PEEK temporary abutments are similar in design to the K220200 Reference device Titanium Temporary Abutments but are made from PEEK. Abutments made from or that include PEEK are similar in short-term temporary usage, just like the K220200 Reference device Temporary Immediate Abutment. The Subject device PEEK material is the same as the K220200 Reference device PEEK material and is subject to the same time of use limitations. Only slight differences in gingival height, prosthetic

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diameter and post height dimensions, and implant connection exist between the Predicate and K220200 Reference devices. The use of PEEK straight temporary abutments is further supported by K170131 Reference device.

#### Angled PEEK Temporary Abutments

The Subject device Aesthetic Angled PEEK Abutments are similar to the Predicate device angled straight Esthetic Contour Titanium Abutments but are made from PEEK. Abutments made from or that include PEEK are similar in short-term temporary usage, the same as the K220200 Reference device Temporary Immediate Abutment. The Subject device PEEK material is the same as the K220200 Reference device PEEK material and is subject to the same time of use limitations. Only slight differences in gingival height, prosthetic diameter and post height dimensions, and implant connection exist between the Predicate and K220200 Reference devices.

The 20° post correction angle and gingival heights for PEEK abutments are further supported by the K170131 Reference device which includes PEEK abutments. Prosthetic diameters are supported by the Predicate device. Slight differences in post height dimensions, and implant connection with the Predicate device do not alter the intended use of the device.

#### Multi-Unit Abutments

The Subject device Straight Multi-Unit Abutments are highly similar to the K22269 Reference device Straight Multi-Unit Abutments, differing only in the implant connection and anodized surface.

The Subject device 17° Angled Multi-Unit Abutments are highly similar to the K22269 Reference device 17° Angled Multi-Unit Abutments, differing only in the implant connection and anodized surface. The Subject device 30° Angled Multi-Unit Abutments are highly similar to the K22269 Reference device 30° Angled Multi-Unit Abutments, differing only in the implant connection, anodized surface, and slightly larger prosthetic diameter option. However, the slightly larger prosthetic diameter option of the Subject device 30° Angled Multi-Unit abutment is supported by the same dimension in the K222269 Reference device 17° Angled Multi-Unit abutments.

Interface copings, temporary cylinders, and healing cap accessories as part of two-part abutments are supported by the Predicate and Reference devices.

#### Temporary Abutments

The Subject device Titanium Temporary Abutments (engaging) are highly similar to the Predicate device and K220200 Reference device Titanium Temporary Abutments (engaging) differing only slightly in gingival height and prosthetic diameter dimensions.

The Subject device Temporary Immediate Abutments are highly similar to the K220200 Reference device Temporary Immediate Abutments, with only slight differences in available prosthetic diameters. The PEEK material is the same as the K220200 Reference device with the same intended period of use.

#### Titanium Base Abutments

The Subject device titanium base abutments are two-piece abutments composed of a stock titanium base cemented to a zirconia top-half. The zirconia conforms to ISO 13356 and the cement used was cleared under K130436. The final patient-matched zirconia component is manufactured by a Keystone Dental validated milling center. These abutments are compared to the K222269 Reference device titanium base abutments (Ti-Base, C-Base®, ANGLEBase®, ELLPTIBase®) differing only slightly in available Gingival Height and Prosthetic Diameter configurations and implant connection, as well as angulation of the patient-matched zirconia component. The difference in manufacturing and angulation is addressed by non-clinical bench testing.

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#### Titanium Blank Abutments

The Subject device titanium blank abutments are highly similar in design to the K22269 Reference device titanium blank abutments differing only slightly in available Gingival Height, Diameter, Post correction angle dimensions and implant connection.

#### Abutment Retention Screws

The Subject device abutment retention screws are fabricated from the same material as the Predicate device. Any differences in surface treatments between the Subject device and Reference device screws were mitigated through non-clinical performance testing of the Subject device.

#### Bar Suprastructure

Implant Solutions PTY LTD (trading as Osteon Medical) is owned by Keystone Dental.

The Subject device KDG-Osteon Precision Milled Suprastructures are highly similar to the K221019 Reference devices, differing only in the list of compatible implant/abutment systems. The Subject device Suprastructures are the same in terms of design parameters and requirements as the K221019 Reference devices.

The KDG-Osteon Precision Milled Suprastructures facilitate the attachment of both removable and fixed dental prosthesis and hence are categorized as Type A and Type B.

- Type A: Intended to act as a supporting structure to facilitate the attachment of removable dental prosthesis and include Primary Bar and Nexus Removable Bar.
- Type B: Intended to act as a supporting structure to facilitate the attachment of fixed dental prosthesis and ● include Melbourne Bar and Nexus Fixed Bar.

| Description | Type A<br>(For Removable Prosthesis) | | Type B<br>(For Fixed Prosthesis) | |
|--------------------------------------------|--------------------------------------|---------|----------------------------------|---------|
| | Minimum | Maximum | Minimum | Maximum |
| Total Cylinders | 2 | 10 | 2 | 10 |
| Suprastructure Span Between Cylinders (mm) | 1 | 30 | 1 | 30 |
| Suprastructure Height (mm) | 3 | 12 | 3 | 22 |
| Suprastructure Width (mm) | 3.4 | 12 | 3.4 | 12 |
| Distal Cantilever Section (mm) | 0 | 15 | 0 | 15 |
| Cylinder Height (mm) | 0 | 4.6 | 0 | 4.6 |
| Cylinder Diameter (mm) | 4.5 | 8 | 4.5 | 8 |

The table below presents the design specifications for the two categories of suprastructures:

Packaging and sterilization of the KDG-Osteon Precision Milled Suprastructure is the K221019 Reference devices.

#### NON-CLINICAL PERFORMANCE TEST DATA

Fatigue testing was performed according to the requirements of ISO 14801:2016, Dentistry – Implants – Dynamic loading test for Endosseous Dental Implants. The worst-case scenarios were chosen based on the FDA Guidance, Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments.

The Subject devices have the same nature of body contact, contact duration, material formulation and sterilization methods compared to the sponsor's Predicate and Reference devices.

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Biological Evaluation of the Subject device was performed according to ISO 10993-1. This evaluation supports the Subject device utilizes nearly identical manufacturing processes to the K210117 Reference device, with slight differences in surface treatment. The difference in surface treatment is addressed within the Biological Evaluation, including evaluation of internal routine monitoring data related to the implant's modified surface treatment and manufacturing cleaning processes of the Subject device.

ISO 10993-5 Cytotoxicity testing on the Subject device or suitable test specimens was performed to support suitable biocompatibility of the Subject device.

Endotoxin testing on the Subject device or suitable test specimens was performed following USP<85> according to the sponsor's endotoxin sampling plan.

Validations were performed on the Subject device or suitable test specimens according to ISO 11137-1:2019, ISO 11137-2:2015 and ISO/TS 13004:2013 to demonstrate suitable sterilization of the Subject device sterile components.

Steam sterilization validations according to ISO 17665-1:2009 for non-sterile and modified components were leveraged from the sponsor's K220200 Reference device.

The results of the non-clinical testing demonstrate conformance with testing requirements and support a finding of substantial equivalence.

Non-clinical worst-case MRI review was performed to evaluate the Subject device components in the MRI environment using scientific rationale and published literature (e.g., Woods, Terry O., Jana G. Delfino, and Sunder Rajan, "Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices." Journal of Testing and Evaluation 49.2 (2019): 783-795), based on the entire system including all variations (all compatible implant bodies, abutments, and material composition. Rationale addressed parameters per the FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment," including magnetically induced displacement force and torque.

No clinical data were included in this submission.

#### CONCLUSION

Overall, minor differences in the designs, implant connections, or sizes between the Subject device, the Predicate device, and the Reference devices do not affect substantial equivalence.

lmplant designs are supported by the similar Predicate device. Implant abutment designs are supported by similar Predicate and Reference devices.

Overall, the Gingival Height dimensions of the Subject device abutments (0.5-7 mm) are highly similar to and encompassed by the Predicate and Reference devices (0.5-7 mm). Overall, the Prosthetic diameters of the Subject device abutment components (3-6 mm) are highly similar to the Predicate and Reference devices (3.4-6.0 mm).

Overall, the Subject, Predicate and Reference devices encompass a similar range of physical dimensions. Minor differences related to implant or abutment designs are mitigated by mechanical performance testing. ISO 14801 mechanical performance testing was performed on worst-case constructs of the Subject device to demonstrate suitability for intended use of the Subject device implant platform, gingival height, and post correction angles combinations.

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The Indications for Use statements for the Subject and Predicate devices are highly similar.

The Technological Characteristics, mode of operation and materials of the Subject device are the same or highly similar to that of the Predicate device. Slight differences in design dimensions do not affect the intended use of the device and are mitigated and/or supported through Reference devices and non-clinical performance testing results. ISO 14801 mechanical performance testing was performed on worst-case constructs of the Subject device to demonstrate suitability for intended use of the Subject device implant platform, gingival height, and post correction angles combinations.

Overall, the data included in this premarket notification demonstrate substantial equivalence of Subject device to the sponsor's Predicate device.

The basis for the belief that the Subject device is substantially equivalent to the Predicate and Reference devices and is summarized in the following comparison tables.

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### Comparison Of Indications for Use

| Device | Indications for Use Statement | | | | | | |
|-----------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|----------------------|------------------------|----------|-----------|-----------|
| Subject Device<br>Genesis ACTIVE Implant<br>System | The Genesis ACTIVE Implant System is intended for use in single-stage or two-stage surgical procedures for replacing single or multiple<br>missing teeth in partially or fully edentulous mandibles and maxillae. The Genesis ACTIVE Implant System supports single or multiple-unit<br>restorations to re-establish patient chewing function and esthetics. Genesis ACTIVE implants are intended for placement following natural<br>tooth loss or for immediate placement into an extraction socket. Immediate function may be achieved when good primary stability is<br>established, and appropriate occlusal loading is applied.<br><br>All digitally designed custom abutments for use with Genesis ACTIVE Implant System implants are to be sent to a Keystone Dental validated<br>milling center for manufacture.<br><br>The KDG-Osteon Precision Milled Suprastructure is indicated for attachment to the Genesis ACTIVE Multi-Unit abutments in the treatment<br>of partially or fully edentulous jaws for the purpose of restoring chewing function. The KDG-Osteon Precision Milled Suprastructure is<br>intended for attachment to a minimum of two (2) abutments. | | | | | | |
| Predicate Device<br>Genesis Implant System<br>(K101545) | The Genesis Implant System is intended for use in single-stage or two-stage surgical procedures in all types of bone in partially or fully<br>edentulous mandibles and maxillae. The Genesis Implant System supports single or multiple-unit restorations to re-establish patient<br>chewing function and esthetics. Genesis implants are intended for placement following natural tooth loss or for immediate placement into<br>an extraction socket. Immediate function may be achieved when good primary stability is established and appropriate occlusal loading is<br>applied. | | | | | | |
| Reference Device<br>Paltop Conical Implant<br>System<br>(K220200) | The Paltop Conical Implant System is indicated for use in surgical and restorative applications for placement in the bone<br>of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing<br>function. Narrow diameter implants are intended for placement in the mandibular central, lateral incisor and maxillary lateral incisor<br>regions of partially edentulous jaws where the horizontal space is limited by the adjacent teeth and roots. The Paltop Conical Implant<br>System is also indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading. | | | | | | |
| Reference Device<br>Paltop Narrow Implant<br>(K210117) | The Paltop Narrow Implant is indicated for use in surgical and restorative applications for placement in the mandibular central, lateral<br>incisor and maxillary lateral incisor regions of partially edentulous jaws where the horizontal space is limited by the adjacent teeth and<br>roots, to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. The Paltop<br>Narrow Implant is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading. | | | | | | |
| Reference Device<br>TAV Medical Dental<br>Implant System<br>(K170131) | TAV Medical Dental Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or<br>lower jaw to provide support for prosthetic devices, such as artificial teeth and in order to restore the patient chewing function. The<br>Implants are indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading | | | | | | |
| Reference Device<br>DESS Dental Smart<br>Solutions<br>(K222269) | DESS Dental Smart Solutions abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or<br>mandibular arch to provide support for prosthetic restorations.<br>All digitally designed custom abutments for use with DESS Bases or Blanks are to be sent to a Terrats Medical<br>validated milling center for manufacture. | | | | | | |
| | Compatible Implant Systems | | | | | | |
| Compatible Implant System | 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) | | | | | |
| | PALTOP DYNAMIC<br>(Internal Hex) | | | 6.0 | WP (6.0) | 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) | | | |
| Reference Device | The Osteon Precision Milled Suprastructure is indicated for attachment to dental abutments in the treatment of partially or fully edentulous jaws for the purpose of restoring chewing function. The Osteon Precision Milled Suprastructures are intended for attachment to a minimum of two (2) abutments. | | | | | | |
| Osteon Precision Milled<br>Suprastructure (K221019)<br>Implant Solutions PTY LTD<br>(trading as Osteon Medical) | The Osteon Milled Suprastructure is indicated for compatibility with the following abutment systems:<br>• Astra Tech Implant System® Multi Base Abutment EV, 4.8mm, max 30°<br>• DESS Dental Multi Unit Abutments, 3.4-5.7 mm, 0°<br>• 3i OSSEOTITE®<br>• Astra Tech OsseoSpeed™<br>• Neodent Grand Morse<br>• NobelReplace® Trilobe<br>• NobelReplace® Conical<br>• Nobel Brånemark System®<br>• Straumann BLX Implants<br>• DESS Dental Multi Unit Abutments, Angled, 3.4-6.5 mm, max 30°<br>• NobelActive® NobelParallel Conical<br>• Straumann® Bone Level<br>• Zimmer Screw Vent® and Tape…