Predicate Devices

Reference Devices

K210117, K051614, K101545, K112795, K212676, K220200

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a dental implant system and suprastructure fabricated using CAD/CAM technology, which is a form of automation but does not inherently involve AI or ML. There are no mentions of AI, ML, or related concepts in the text.

Therapeutic

No.
The device components are prosthetic components intended to aid in prosthetic rehabilitation to restore chewing function, not to treat or cure a disease.

Diagnostic

No

Explanation: The devices described are prosthetic components (abutments and suprastructures) used for restoring chewing function. They are not intended for diagnosing a disease or condition.

SaMD (Software as a Medical Device)

No

The device description explicitly states it comprises physical components like "endosseous rootform dental abutments, abutment screws, and other associated components" and a "Precision Milled Suprastructure" made of "biocompatible Titanium alloy". While CAD/CAM technology is used in manufacturing, the device itself is a physical implant and prosthetic component, not software.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use/Indications for Use: The intended use is for prosthetic rehabilitation by connecting to dental implants to restore chewing function. This is a mechanical and structural function within the body, not a diagnostic test performed on samples taken from the body.
Device Description: The description details components like abutments, screws, and suprastructures made of titanium alloy, designed to be surgically implanted and attached to dental implants. This aligns with a medical device used for physical restoration.
Lack of IVD Characteristics: There is no mention of:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
- Reagents, calibrators, or controls typically associated with IVD tests.

The device is clearly intended for surgical implantation and mechanical support of dental prosthetics, which falls under the category of a medical device, but not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

KDG Abutments are pre-manufactured prosthetic components for direct connection to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation.

The KDG-Osteon Precision Milled Suprastructure is indicated for attachment to KDG 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

NHA

Device Description

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 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 cemented.

The purpose of this submission is the marketing clearance for KDG Abutments which comprises endosseous rootform dental abutments, abutment screws, and other associated components for single-unit, and overdenture restorations. The Subject device abutment components introduce 30° post correction angle multi-unit abutments compatible with the sponsor's previously cleared implants.

The Keystone family of abutments are compatible with the Keystone implants which have a hex-lobe internal connection. The Paltop family of abutments are compatible with the Paltop implants which have hex-wall internal connection.

The KDG-Osteon Precision Milled Suprastructure is an overdenture bar which is compatible with the Subject device abutments. The overdenture bar is dental restorative device that is intended for screw-retained attachment to dental abutments to aid in the treatment of partial and 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 and is used to facilitate the attachment of both fixed and removable prostheses.

The Osteon Precision Milled Suprastructure is designed for an individual patient from scans of the patient's impression. The suprastructure is manufactured in biocompatible Titanium alloy with the aid of Computer Aided Design (CAD) and Computer Aided Manufacturing (CAM) technology. All CAD/CAM fabrication is performed by Osteon Medical, within our premises. The abutment-born Suprastructure is only indicated for straight placement and is not to exceed the maximum angulation of the connected multi-unit abutments.

KDG-Osteon Precision Milled Suprastructures facilitate the attachment of both removable and fixed dental prosthesis and hence categorized as type B. The design specifications are listed in the table below.

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.

The Subject device abutments, abutment screws, and bar suprastructure are fabricated from Ti-6Al-4V ELI titanium alloy (Grade 23) which conforms to ASTM F136, Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401).

All Subject device components are one-time use device components are provided sterile and sterilized by gamma irradiation except for the Single-Unit and Multi-Unit copings, the KDG-Osteon Precision Milled Suprastructure and all replacement screws which are provided non-sterile. Devices provided as non-sterile are sterilized by steam.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

edentulous maxilla and mandible, jaws

Indicated Patient Age Range

Adult

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 for each family of abutments according to the requirements of ISO 14801:2016, Dentistry – Implants – Dynamic loading test for Endosseous Dental Implants. The worst-case scenario for each family was chosen based on the FDA Guidance, Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments. Fatigue testing of the sponsor's K212676 Reference device is leveraged for the KDG-Osteon Precision Milled Suprastructure.

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

Test results and Biological Evaluation per ISO 10993 performed for the sponsor's K210117 Reference device are leveraged to demonstrate suitable biocompatibility of the Subject device abutments.

Test results and Biological Evaluation per ISO 10993 performed for the sponsor's K212676 Reference device are leveraged to demonstrate suitable biocompatibility of the Subject device KDG-Osteon Precision Milled Suprastructure.

Test results and Sterilization Validations per ISO 11137-2 and ISO/TS 13004 performed for the sponsor's K210117 Reference device are leveraged to demonstrate suitable sterilization of the Subject device sterile components.

Cleaning validation and sterilization per ISO 17665-1, for non-sterile and sterile abutment components which may be modified and require subsequent sterilization is leveraged from the sponsor's K210117 Reference device.

Sterilization validation per ISO 17665-1 and ISO/TS 17665-2 for the KDG-Osteon Precision Milled Suprastructure is leveraged from the sponsor's K212676 Reference device.

Sterile device sterile barrier shelf-life packaging integrity is leveraged from the sponsor's K101545 and K210117 Reference devices.

Non-clinical worst-case MRI review was performed to evaluate the Subject device including all compatible implant fixtures, abutments, bars, and fixation screws and their respective material composition in the MRI environment using scientific rationale and published literature (e.g., Woods, Terry O., Jana G. Delfino, and Sunder Rajan, "Assessment of Maqnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices." Journal of Testing and Evaluation 49.2 (2019): 783-795). 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.

The results of the non-clinical testing demonstrate conformance with testing requirements and support a finding of substantial equivalence with respect to the Subject and Predicate device.

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

Not Found

Predicate Device(s)

K161416

Reference Device(s)

K210117, K051614, K101545, K112795, K212676, K220200

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 872.3630 Endosseous dental implant abutment.

(a)
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.(b)
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.)

Summary

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Keystone Dental Inc. % Chris Brown Manager Aclivi, LLC 3250 Brackley Drive Ann Arbor, Michigan 48105

Re: K221381

Trade/Device Name: KDG Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: May 11, 2022 Received: May 13, 2022

Dear Chris Brown:

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.

1

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 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) K221381

Device Name KDG Abutments

Indications for Use (Describe)

KDG Abutments are pre-manufactured prosthetic components for direct connection to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation.

The KDG-Osteon Precision Milled Suprastructure is indicated for attachment to KDG 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 K221381 Keystone Dental Inc KDG Abutments

ADMINISTRATIVE INFORMATION

| Manufacturer Name | Keystone Dental Inc.
154 Middlesex Turnpike
Burlington, MA 01803 |
|-------------------|-----------------------------------------------------------------------------------|
| Telephone: | +1 (781) 328-3490 |
| Fax: | +1 (781) 328-3400 |
| Official Contact | Nancy DeAngelo, Regulatory Affairs Manager
Email: NDeAngelo@keystonedental.com |
| Date submitted: | 8/3/2022 |

DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name:	KDG Abutments
Classification Name:	Abutment, Implant, Dental, Endosseous
Classification Regulation	21 CFR 872.3630
Device Class:	Class II
Product Code:	NHA
Review Panel:	Dental
Reviewing Branch:	Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Dental Devices (DHT1B)

PREDICATE DEVICE INFORMATION

The Subject device abutments are substantially equivalent in Indications for Use, and technological/design principles to the following legally marketed Predicate device with Reference devices leveraged for technology, implant connection and design principles. The Subject device KDG-Osteon Precision Milled Suprastructure is substantially equivalent to the K212676 Reference device.

510(k)	Predicate Device Name	Company Name
K161416	Multi-unit Abutment Plus	Nobel Biocare AB

510(k)	Reference Predicate Device Name	Company Name
K210117	Paltop Narrow Implant	Paltop Advanced Dental Solutions
K051614	Lifecore Primaconnex™ Internal Connection Implant System	Lifecore Biomedical, Inc. / Keystone
K101545	Genesis Implant System	Keystone Dental, Inc.
K112795	Paltop Advanced Dental Solution System	Paltop Advanced Dental Solutions
K212676	Osteon Precision Milled Suprastructure	Implant Solutions PTY LTD (Osteon Medical)
K220200*	Paltop Conical Implant System	Paltop Advanced Dental Solutions

*(compatible abutment accessories)

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DEVICE DESCRIPTION

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 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 cemented.

The purpose of this submission is the marketing clearance for KDG Abutments which comprises endosseous rootform dental abutments, abutment screws, and other associated components for single-unit, and overdenture restorations. The Subject device abutment components introduce 30° post correction angle multi-unit abutments compatible with the sponsor's previously cleared implants.

The Keystone family of abutments are compatible with the Keystone implants which have a hex-lobe internal connection. The Paltop family of abutments are compatible with the Paltop implants which have hex-wall internal connection.

			Abutment Design			Bar
Implant Family	Implant
Diameter
(mm)	Platform
Diameter
(mm)	Straight Multi-Unit	Angled Multi-Unit	Straight Single-Unit	Bar Suprastructure
Keystone
PrimaConnex	3.3, 3.5	3.3 (SD)	X	X	n/a	X
PrimaConnex	4.0, 4.1	3.75 (RD)	X	X	n/a	X
	5.0	4.5 (WD)	X	X	n/a	X
Keystone
Genesis	3.8	3.6 (SD)	X	X	n/a	X
	4.5	3.9 (RD)	X	X	n/a	X
	5.5, 6.5	4.9 (WD)	X	X	n/a	X
Paltop
Advanced Dental
System	3.75		X	X	X	X
	4.2	3.70 (SP)	X	X	X	X
	5.0		X	X	X	X
	6.0	4.5 (WP)	X	X	X	X
		Interface	Non-Indexed	Indexed	Non-Indexed	Non-Indexed
		Material	Grade 23 Titanium	Grade 23 Titanium	Grade 23 Titanium	Grade 23 Titanium

KDG Abutments - Abutment Designs

The KDG-Osteon Precision Milled Suprastructure is an overdenture bar which is compatible with the Subject device abutments. The overdenture bar is dental restorative device that is intended for screw-retained attachment to dental abutments to aid in the treatment of partial and 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 and is used to facilitate the attachment of both fixed and removable prostheses.

The Osteon Precision Milled Suprastructure is designed for an individual patient from scans of the patient's impression. The suprastructure is manufactured in biocompatible Titanium alloy with the aid of Computer Aided Design (CAD) and Computer Aided Manufacturing (CAM) technology. All CAD/CAM fabrication is performed by Osteon Medical, within our premises. The abutment-born Suprastructure is only indicated for straight placement and is not to exceed the maximum angulation of the connected multi-unit abutments.

KDG-Osteon Precision Milled Suprastructures facilitate the attachment of both removable and fixed dental prosthesis and hence categorized as type B. The design specifications are listed in the table below.

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.

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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
(facilitates Removable Prosthesis) | | Type B
(facilitates 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 two categories of suprastructures:

The Subject device abutments, abutment screws, and bar suprastructure are fabricated from Ti-6Al-4V ELI titanium alloy (Grade 23) which conforms to ASTM F136, Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401).

All Subject device components are one-time use device components are provided sterile and sterilized by gamma irradiation except for the Single-Unit and Multi-Unit copings, the KDG-Osteon Precision Milled Suprastructure and all replacement screws which are provided non-sterile. Devices provided as non-sterile are sterilized by steam.

INDICATIONS FOR USE

KDG Abutments are pre-manufactured prosthetic components for direct connection to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation.

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

EQUIVALENCE TO MARKETED DEVICE

The Subject device abutments are highly similar to the Predicate device with respect to Indications for Use and technological principles. The Subject device suprastructure is highly similar to the K212676 Reference device with respect to Indications for Use and technological principles. The Comparison tables below compare the Indications for Use and Technological Characteristics of the Subject and Predicate/Reference devices.

Comparison of Indications for Use Statements

The Subject and Predicate devices have highly similar Indications for Use Statements (IFUS) with respect to the abutment components, differing only in device name and grammar. The Subject and the sponsor's K212676 Reference device have similar wording the use of the bar suprastructure, differing only in the list of compatible implant/abutment systems. The IFUSs express equivalent intended use to facilitate dental prosthetic rehabilitation, and the indications are expressed equivalently using different specific wording.

Similarly, the differences between the Subject device IFUS and that of each Reference device are related to the specific device names and specific use of implants which are part of the Reference devices. None of these minor differences impact substantial equivalence with the Predicate device because all IFUS express equivalent intended use to facilitate dental prosthetic rehabilitations are expressed equivalently using different specific wording.

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Comparison of Technological Characteristics

Overall, the Subject device abutments are highly similar to the Predicate and Reference device abutments. Abutment designs are the same in principle. 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.

Sterilization and packaging of the sterile Subject device components are the Sponsor's K210117, K101545 and K201334 Reference devices. Cleaning and sterile Subject device abutment components are the same as and leveraged from the K210117 Reference device. Packaging and sterilization of the KDG-Osteon Precision Milled Suprastructure is the same as and leveraged from the K212676 Reference device.

Multi-Unit Abutments

The Subject device Straight Multi-Unit Abutments are the highly similar to the Predicate device Straight Multi-Unit Abutments, differing in the implant connection. Subject device Straight Multi-Unit Abutment implant connections, Gingival Heights and Prosthetic Diameters are supported by the sponsor's Reference devices.

The Subject device 17° Angulated Multi-Unit Abutments are highly similar to the Predicate device 17° Angulated Multi-Unit Abutments differing in the implant connection. Subject device 17° Angulated Multi-Unit Abutment implant connections, Gingival Heights and Prosthetic Diameters are supported by the sponsor's Reference devices.

The Subject device 30° Angulated Multi-Unit Abutments are highly similar to the Predicate device 30° Angulated Multi-Unit Abutments differing in the implant connection. Subject device 30° Angulated Multi-Unit Abutment implant connections, Gingival Heights and Prosthetic Diameters are supported by the sponsor's Reference devices.

Multi-Unit abutment accessories which include interface copings, temporary cylinders, and healing caps as part of two-part abutments are supported by the sponsor's K210117 Reference device. The use of Multi-Unit Abutment accessories including limitations for hand modification of cylinders is the same as the K210117 Reference device.

Straight Single-Unit Abutments

The Subject device Paltop family Straight Single-Unit Abutments are highly similar to the sponsor's K210117 Reference device Straight Single-Unit Abutments, adding additional implant connections. Single-Unit abutment accessories which include interface copings, temporary cylinders, and healing caps as part of two-part abutments and are supported by the sponsor's K210117 Reference device. The use of Single-Unit Abutment accessories including limitations for hand modification of cylinders is the same as the K210117 Reference device.

Overall, minor differences in the Subject device abutment designs, correction angles and implant connection do not affect substantial equivalence. The Gingival Height dimensions of the Subject device abutment designs (1.0-5.0 mm) are highly similar to Predicate and Reference devices (1.0-5.0 mm). The Prosthetic diameters of the Subject device abutment components (4.8-5.0 mm) are highly similar and encompassed by the sponsor's Reference devices (4.5-5.0 mm).

Any differences in implant abutment designs or dimensions have been mitigated and demonstrated to be suitable for intended use through non-clinical bench performance testing.

Bar Suprastructure

The Subject device KDG-Osteon Precision Milled Suprastructure is the highly similar as the K212676 Reference device, differing only in the list of compatible implant/abutment systems. The Subject device is the same in terms of design parameters and requirements, as the K212676 Reference device.

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Compatibility of the K212676 Reference device was previously demonstrated for the K051614, K101545 and K112795 Reference devices. Compatibility with 30° abutments is supported by the K212676 Reference device and through the non-clinical performance testing of the Subject device.

NON-CLINICAL PERFORMANCE TEST DATA