Predicate Devices

Reference Devices

K220200, K210117, K170131, K222269, K221019, K130436

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the materials, design, and manufacturing processes (including CAD/CAM for suprastructures) of dental implants and associated components. There is no mention of AI or ML being used in the device's function, design process beyond standard CAD/CAM, or analysis of patient data.

Therapeutic

Yes.
The device, the Genesis ACTIVE Implant System, is intended for use in single-stage or two-stage surgical procedures for replacing single or multiple missing teeth to re-establish chewing function and esthetics. This falls under the definition of a therapeutic device as it treats a condition (missing teeth) to restore a bodily function (chewing).

Diagnostic

No

The device description clearly states its purpose is for replacing missing teeth and providing support for prosthetic devices to restore chewing function. There is no mention of the device being used to diagnose conditions or diseases.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical components such as endosseous root-form dental implants, abutments, screws, and suprastructures, which are hardware. While CAD/CAM technology is mentioned for the suprastructure, the core device is a physical implant system.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly describes a surgical implant system for replacing missing teeth and restoring chewing function and esthetics. This is a therapeutic and restorative purpose, not a diagnostic one.
Device Description: The device components are described as endosseous dental implants, abutments, screws, and suprastructures. These are all physical devices surgically implanted or attached to the patient's body.
Lack of Diagnostic Function: There is no mention of the device being used to diagnose a condition, analyze samples from the body (like blood, urine, or tissue), or provide information about a patient's health status through in vitro testing.
Performance Studies: The performance studies focus on mechanical properties (fatigue testing), biocompatibility, sterilization, and MRI compatibility. These are relevant to the safety and performance of a surgically implanted device, not an IVD.

In summary, the Genesis ACTIVE Implant System is a medical device intended for surgical implantation and restoration, not for in vitro diagnostic testing.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

DZE, NHA

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

mandibles and maxillae

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

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 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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K101545

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K220200, K210117, K170131, K222269, K221019, K130436

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 872.3640 Endosseous dental implant.

(a)
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.(b)
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.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)
☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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

ADMINISTRATIVE INFORMATION

| Manufacturer Name | Keystone Dental Inc.
154 Middlesex Turnpike
Burlington, MA 01803 |
|--------------------|-------------------------------------------------------------------------------------------------------------------|
| Telephone:
Fax: | +1 (781) 328-3490
+1 (781) 328-3400 |
| Official Contact | Nancy DeAngelo, Regulatory Affairs Manager
Email: ndeangelo@keystonedental.com
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)
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