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.

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 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.

AI/ML Overview

The provided document is a 510(k) Premarket Notification from the FDA to Keystone Dental Inc. regarding their KDG Abutments. This document primarily focuses on establishing substantial equivalence to predicate devices based on indications for use and technological characteristics, supported by non-clinical performance data.

Crucially, this document does NOT contain information related to a study that proves the device meets specific acceptance criteria for AI/ML performance, nor does it describe a multi-reader multi-case (MRMC) comparative effectiveness study, standalone algorithm performance, or the establishment of ground truth for training or test sets in the context of an AI-powered device.

The acceptance criteria mentioned in the document refer to the performance of dental abutments in the context of mechanical testing (fatigue testing per ISO 14801:2016) and biocompatibility, not the performance of an AI/ML algorithm.

Therefore, I cannot provide the requested information for acceptance criteria and studies related to AI/ML performance based on the input text. The information in the document pertains to traditional medical device clearance.

Summary

{0}------------------------------------------------

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

{2}------------------------------------------------

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.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

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

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

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

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

{3}------------------------------------------------

510(k) Summary K221381 Keystone Dental Inc KDG Abutments

ADMINISTRATIVE INFORMATION

Manufacturer Name	Keystone Dental Inc.154 Middlesex TurnpikeBurlington, MA 01803
Telephone:	+1 (781) 328-3490
Fax:	+1 (781) 328-3400
Official Contact	Nancy DeAngelo, Regulatory Affairs ManagerEmail: 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)

{4}------------------------------------------------

DEVICE DESCRIPTION

			Abutment Design			Bar
Implant Family	ImplantDiameter(mm)	PlatformDiameter(mm)	Straight Multi-Unit	Angled Multi-Unit	Straight Single-Unit	Bar Suprastructure
KeystonePrimaConnex	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
KeystoneGenesis	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
PaltopAdvanced DentalSystem	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

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.

{5}------------------------------------------------

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:

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.

{6}------------------------------------------------

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.

{7}------------------------------------------------

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

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.

CONCLUSION

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

Overall, 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 abutment design and compatible implant connection do not affect the intended use of the device and are mitigated or supported through non-clinical

{8}------------------------------------------------

performance testing results. ISO 14801 mechanical performance testing 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 Subject and Predicate devices have been demonstrated to be Substantially Equivalent.

The basis for the belief that the Subject device is substantially equivalent to the Predicate device and incorporates technology of the Reference devices is summarized in the following Indication for Use and Technological Characteristics comparison tables.

{9}------------------------------------------------

Comparison Table - Indications for Use Statements

Device	Indications for Use Statement
Subject DeviceKDG AbutmentsKeystone Dental, Inc.	KDG Abutments are pre-manufactured prosthetic components for direct connection to endosseous dental implants and areintended for use as an aid in prosthetic rehabilitation.
	The KDG-Osteon Precision Milled Suprastructure is indicated for attachment to KDG Abutments Multi-Unit abutments in thetreatment of partially or fully edentulous jaws for the purpose of restoring chewing function. The KDG-Osteon PrecisionMilled Suprastructure is intended for attachment to a minimum of two (2) abutments. KDG Abutments Multi-Unitabutments have a prosthetic diameter of 4.8 mm or 5.0 mm and may have up to 30° abutment post correction angle.
Predicate DeviceMulti-unit Abutment Plus(K161416)Nobel Biocare AB	The Multi-unit Abutment Plus is a pre-manufactured prosthetic component directly connected to the endosseous dentalimplant and is intended for use as an aid in prosthetic rehabilitation.
Reference DevicePaltop Narrow Implant (K210117)Paltop Advanced Dental Solutions	The Paltop Narrow Implant is indicated for use in surgical and restorative applications for placement in the mandibularcentral, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws where the horizontal space is limitedby the adjacent teeth and roots, to provide support for prosthetic devices, such as artificial teeth, in order to restore thepatient's chewing function. The Paltop Narrow Implant is indicated also for immediate loading when good primary stability isachieved and with appropriate occlusal loading.
Reference DeviceLifecore Primaconnex™ InternalConnection Implant System(K051614)Lifecore Biomedical, Inc. /Keystone Dental, Inc	Lifecore Biomedical Dental Implant System implants are intended for use in partially or fully edentulous mandibles andmaxillae, in support of single or multiple-unit restorations including; cement retained, screw retained, or overdenturerestorations, and terminal or intermediate abutment support for fixed bridgework.The PrimaConnex Internal Connection Implant is a threaded internal connection implant. The PrimaConnex InternalConnection Implant is intended for immediate placement, where immediate implant placement is defined by theInternational Congress of Oral Implantologists (ICOI) as the placement of an implant at the time of tooth extraction, into theextraction socket.The PrimaConnex Internal Connection Implant is intended for immediate provisionalization, non-occlusal load. ImmediateProvisionalization is defined by the International Congress of Oral Implantologists (ICOI) as a clinical protocol for theplacement of an interim prosthesis with or without occlusal contact with the opposing dentition, at the same clinical visit ofimplant placement. The PrimaConnex Internal Connection Implant can be restored with a temporary prosthesis in singletooth and multiple tooth applications with good quality bone.
Reference DeviceGenesis Implant System(K101545)Keystone Dental, Inc.	The Genesis Implant System is intended for use in single-stage or two-stage surgical procedures in all types of bone inpartially or fully edentulous mandibles and maxillae. The Genesis Implant System supports single or multiple-unitrestorations to re-establish patient chewing function and esthetics. Genesis implants are intended for placement followingnatural tooth loss or for immediate placement into an extraction socket. Immediate function may be achieved when goodprimary stability is established and appropriate occlusal loading is applied.
Reference DevicePaltop Advanced Dental SolutionsSystem (K112795)Paltop Advanced Dental Solutions	The Paltop Dental Implant System is indicated for use in surgical and restorative applications for placement in the bone ofthe upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient'schewing function. The Paltop Dental Implant System is indicated also for immediate loading when good primary stability isachieved and with appropriate occlusal loading.
Reference DeviceOsteon Precision MilledSuprastructure (K212676)Implant Solutions PTY LTD (tradingas Osteon Medical)	• Keystone Multi Unit Abutment, 4.8mm, 0°	The Osteon Precision Milled Suprastructure is indicated for attachment to dental abutments in the treatment of partially orfully edentulous jaws for the purpose of restoring chewing function. The Osteon Precision Milled Suprastructures areintended for attachment to a minimum of two (2) abutments.The Osteon Milled Suprastructure is indicated for compatibility with the following abutment systems:• Nobel Biocare Multi Unit Abutment Plus, 4.8mm, max 30°• Nobel Biocare Xeal Abutments, 4.8mm, max 30°• Nobel Biocare Multi Unit Abutment, 4.8mm, max 30°• MIS Multi-unit Abutments, 4.8mmo C1 Conical Connection Implant System, max 30°o V3 Conical Connection Implant System, max 30°o Internal Hex Implant System, max 30°o Conical Connection, max 30°• Southern Compact Conical Abutments, 4.8mmo MAX Implant System, 0°o Provata Implant System, max 30°o Deep Conical (DC) Implants, 0°o Piccolo Implants, 0°o External Hex Implants, max 30°• Astra Tech Implant System® Multi Base Abutment EV, 4.8mm, max 30°
• Neodent GM Mini Conical Abutment, 4.8mm, max 30°
• Implant Direct GPS® Angled Abutment, 5.0mm, max 30°
• Dentium SuperLine® Abutments, 4.5-5.5mm, max 30°
• Zimmer Angled Tapered Abutments, 4.5mm, max 30°
• Paltop Multi Unit Abutment, 5.0mm, max 17°

{10}------------------------------------------------

Technological Characteristics Comparison Table - Abutments

Comparison	Subject DeviceKDG AbutmentsKeystone Dental, Inc.	Predicate DeviceMulti-unit Abutment Plus (K161416)Nobel Biocare AB	Reference DevicePaltop Narrow Implant (K210117)Paltop Advanced Dental Solutions	Reference DeviceLifecore Primaconnex™ Internal Connection ImplantSystem (K051614)Lifecore Biomedical, Inc. / Keystone Dental, Inc	Comparison	Subject DeviceKDG AbutmentsKeystone Dental, Inc.	Reference DeviceGenesis Implant System (K101545)Keystone Dental, Inc.	Reference DevicePaltop Advanced Dental Solutions System(K112795)Paltop Advanced Dental Solutions
Product Code	NHA	NHA	DZE, NHA	DZE, NHA	Product Code	NHA	DZE, NHA	DZE, NHA
Regulation	872.3630	872.3630	872.3640, 872.3630	872.3640, 872.3630	Regulation	872.3630	872.3640, 872.3630	872.3640, 872.3630
Classification	Class II	Class II	Class II	Class II	Classification	Class II	Class II	Class II
Intended Use	Functional and esthetic rehabilitation of theedentulous maxilla and mandible	Functional and esthetic rehabilitation of theedentulous maxilla and mandible	Functional and esthetic rehabilitation of theedentulous maxilla and mandible	Functional and esthetic rehabilitation of the edentulousmaxilla and mandible	Intended Use	Functional and esthetic rehabilitation of theedentulous maxilla and mandible	Functional and esthetic rehabilitation of theedentulous maxilla and mandible	Functional and esthetic rehabilitation of theedentulous maxilla and mandible
Reason for Predicate/Reference	n/a	Indications for Use, abutment designs	Abutment designs, material, sterilization,biocompatibility, abutment accessories	Implant/Interface compatibility	Reason for Predicate/Reference	n/a	Implant/Interface compatibility	Implant/Interface compatibility
Sterile components Sterilization	Gamma Sterilization	Gamma Sterilization	Gamma Sterilization	Gamma Sterilization	Sterile components Sterilization	Gamma Sterilization	Gamma Sterilization	Gamma Sterilization
Non-Sterile components	Steam sterilization	Steam sterilization	Steam sterilization	Not specified	Non-Sterile components	Steam sterilization	Steam sterilization	Steam sterilization
Abutment/Screw Material	Grade 23 Titanium Alloy, no modified surface	Titanium vanadium alloy	Grade 23 Titanium Alloy, no modified surface	Grade 23 Titanium Alloy, no modified surface	Abutment/Screw Material	Grade 23 Titanium Alloy, no modified surface	Grade 23 Titanium Alloy, no modified surface	Grade 23 Titanium Alloy, no modified surface
Use with Implant diameters	3.3, 3.5, 3.8, 4.0, 4.1, 4.5, 5.0, 5,5, 6.5 mm (Keystone)3.75, 4.2, 5.0, 6.0 mm (Paltop)	3.5 and 3.75 mm (NP), 4.3 and 5.0 mm (RP),5.5 mm (WP)	3.0 mm, 3.25 mm (NP)	3.3 and 3.5 (SD), 4.0 and 4.1 (RD), 5.0 mm (WD)	Use with Implant diameters	3.3, 3.5, 3.8, 4.0, 4.1, 4.5, 5.0, 5,5, 6.5 mm (Keystone)3.75, 4.2, 5.0, 6.0 mm (Paltop)	3.8, 4.5. 5.5, 6.5 mm	3.75 mm, 4.2 mm and 5.0 mm (SP), 6.0 (WP)
Platform Diameters	3.3, 3.6 mm (SD)Keystone3.75, 3.9 mm (RD)Family4.5, 4.9 mm (WD)3.7 mm (SP)PaltopFamily4.5 mm (WP)	3.5 mm (NP)3.9 mm (RP)5.1 mm (WP)	3.0, 3.25 mm (NP)	3.3 mm (SD)3.75 mm (RD)4.5 mm (WD)	Platform Diameters	KeystoneFamilyPaltopFamily	3.3, 3.6 mm (SD)3.75, 3.9 mm (RD)4.5, 4.9 mm (WD)3.7 mm (SP)4.5 mm (WP)	3.6 mm (SD)3.9 mm (RD)4.9 mm (WD)	3.7 mm (SP)4.5 mm (WP)
Straight Multi-Unit Abutment	Keystone Family (connection)Design GH PD CA Min PHw/Temp Cylinder 1,2 3,4 4.8 0 4 (min)w/Interface Coping 1,2 3,4 4.8 0 4.5w/Healing Cap 1,2 3,4 4.8 0 3Paltop Family (connection)Design GH PD CA PHw/Temp Cylinder 1,2 3,4,5 5 0 4 (min)w/Interface Coping 1,2 3,4,5 5 0 4.5 (min)w/Healing Cap 1,2 3,4,5 5 0 4.5	MinDesign GH PD CA PHw/TempCylinder1.5,2.5,3.5,4.5nd 0 nd(coping)	Design GH PD CA PHw/Temp Cylinder 1,2 3,4,5 5 0 5 (min)w/Interface Coping 1,2 3,4,5 5 0 4.5 (min)w/Healing Cap 1,2 3,4,5 5 0 4.5	n/a	Straight Multi-Unit AbutmentImage: Straight Multi-Unit Abutment	Keystone Family (connection)Design GH PD CA Min PHw/Temp Cylinder 1,2 3,4 4.8 0 4 (min)w/Interface Coping 1,2 3,4 4.8 0 4.5w/Healing Cap 1,2 3,4 4.8 0 3Paltop Family (connection)Design GH PD CA PHw/Temp Cylinder 1,2 3,4,5 5 0 4 (min)w/Interface Coping 1,2 3,4,5 5 0 4.5 (min)w/Healing Cap 1,2 3,4,5 5 0 4.5	n/a	Design GH PD CA PHw/Ti-Abutment(Cylinder) 1,2 3 4.5 0 n/sw/Healing Cap 1,2 3 4.5 0 3.3
Angulated Multi-Unit Abutment17° and 30°	Keystone Family (connection) 17°, 30°Design GH PD CA Min PHw/Temp Cylinder 3, 4 4.8 17,30 4 (min)w/Interface Coping 3, 4 4.8 17,30 4.5w/Healing Cap 3, 4 4.8 17,30 3Paltop Family (connection) 17°Design GH PD CA PHw/Temp Cylinder 2.5,3.25,4 5 17 4 (min)w/Interface Coping 2.5,3.25,4 5 17 4.5 (min)w/Healing Cap 2.5,3.25,4 5 17 4.5Paltop Family (connection) 30°Design GH PD CA PHw/Temp Cylinder 3.5,4.5 5 30 4 (min)w/Interface Coping 3.5,4.5 5 30 4.5 (min)w/Healing Cap 3.5,4.5 5 30 4.5	17° Multi-Unit AbutmentsDesign GH PD CA Min PHw/TempCylinder2.5, 3.5 nd 17 nd(coping)30° Multi-Unit AbutmentsDesign GH PD CA Min PHw/TempCylinder3.5, 4.5 nd 30 nd(coping)	17° Multi-Unit AbutmentsDesign GH PD CA PH17°w/Temp Cylinder 3 5 17 5 (min)17°w/ Interface Coping 3 5 17 4.5 (min)17°w/ Healing Cap 3 5 17 4.5	n/a	Angulated Multi-Unit AbutmentImage: Angulated Multi-Unit Abutment	Keystone Family (connection) 17°, 30°Design GH PD CA Min PHw/Temp Cylinder 3,4 4.8 17,30 4 (min)w/Interface Coping 3, 4 4.8 17,30 4.5w/Healing Cap 3,4 4.8 17,30 3Paltop Family (connection) 17°Design GH PD CA PHw/Temp Cylinder 2.5,3.25,4 5 17 4 (min)w/Interface Coping 2.5,3.25,4 5 17 4.5 (min)w/Healing Cap 2.5,3.25,4 5 17 4.5Paltop Family (connection) 30°Design GH PD CA PHw/Temp Cylinder 3.5,4.5 5 30 4 (min)w/Interface Coping 3.5,4.5 5 30 4.5 (min)w/Healing Cap 3.5,4.5 5 30 4.5	n/a	Design GH PD CA PH17°w/Ti-Abutment(Cylinder) 2,3 4.5 17 n/s17°w/ Healing Cap 2,3 4.5 17 3.3
Straight Single-Unit Abutment	Paltop Family (connection)Design GH PD CA PHw/Temp Cylinder 1,2 3,4 5 0 4 (min)w/Interface Coping 1,2 3,4 5 0 4.5 (min)w/Healing Cap 1,2 3,4 5 0 4.5	n/a	Design GH PD CA PHw/Temp Cylinder 1,2 3,4 4.5 0 5 (min)w/Interface Coping 1,2 3,4 4.5 0 5.5w/Healing Cap 1,2 3,4 4.5 0 3.5	n/a	Straight Single-Unit AbutmentImage: Straight Single-Unit Abutment	Paltop Family (connection)Design GH PD CA PHw/Temp Cylinder 1,2 3,4 5 0 4 (min)w/Interface Coping 1,2 3,4 5 0 4.5 (min)w/Healing Cap 1,2 3,4 5 0 4.5	n/a	n/a

{11}------------------------------------------------

{12}------------------------------------------------

Comparison	Subject DeviceKDG AbutmentsKeystone Dental, Inc.	Reference DeviceOsteon Precision Milled Suprastructure(K212676)Implant Solutions PTY LTD (trading as OsteonMedical)
Product Code	NHA	NHA
Regulation	872.3630	872.3630
Classification	Class II	Class II
Intended Use	Functional and esthetic rehabilitation of theedentulous maxilla and mandible	Functional and esthetic rehabilitation of theedentulous maxilla and mandible
Reason for Predicate/Reference	n/a	Overstructure bar design
Non-Sterile components	Steam sterilization	Steam sterilization
Abutment/Screw Material	Grade 23 Titanium Alloy, no modified surface	Grade 23 Titanium Alloy, no modified surface
Design/Technology	CAD/CAM milling	CAD/CAM milling
Fixation	Abutment-borne	Abutment-borne
Design/Construction	Patient specific/machined	Patient specific/machined
Target Population	Adult	Adult
Prescription/OTC	Prescription	Prescription
Prosthetic Diameters of CompatibleMulti-Unit Abutments	4.8 mm, 5.0 mm	4.5-5.5 mm
Multi-Unit Abutment PostCorrection Angles	0°, 17°, 30°	0°, 17°, 30°
Total Cylinders	2 - 10	2 - 10
Suprastructure/Bar Span BetweenCylinders	1 mm - 30 mm	1 mm - 30 mm
Superstructure/Bar Height	3.4 mm - 12 mm	3.4 mm - 12 mm
Superstructure/Bar Height	3.4 mm - 12 mm	3.4 mm - 12 mm
Distal Cantilever Section/DistalExtension	0 - 15 mm	0 - 15 mm
Cylinder Height	0 – 4.6 mm	0 - 4.6 mm
Cylinder Diameter	4 – 8 mm	4 - 8 mm

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.)