Inclusive® Titanium Abutments are premanufactured prosthetic components connected to endosseous dental implants in edentulous or partially edentulous maxilla or mandible to provide support for cement-retained or screw-retained prosthetic restorations. All digitally designed abutments for use with Inclusive® Titanium Abutments for CAD/CAM are intended to be sent to a Prismatik Dentalcraft validated milling center for manufacture.

Device Description

Inclusive® Titanium Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation. Inclusive® Titanium Abutments are designed and fabricated to be compatible with Keystone® Dental PrimaConnex® Implant System, Neodent® GM Implant System, Straumann® BLX Implant System, Implant Direct® Legacy® Implant System, Implant Direct® InterActive® Implant System, Implant Direct® RePlant® Implant System. The products are made from titanium alloy Ti-6A1-4V ELI, which meets ASTM F136-13(2021), Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). They include Inclusive® Titanium Abutment Blanks intended to be used to fabricate one-piece, all-titanium, patient-specific abutments using CAD/CAM technology and Inclusive® Titanium Abutments 4.5mmH and 6mmH intended to be used for support of fabricated crowns/bridges or a zirconia coping to complete the two-piece abutment. The zirconium coping intended for use with the Inclusive® Titanium Abutments are made from zirconium oxide ceramic, conforming to ISO 13356 Implants for surgery - Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP). Inclusive® Titanium Abutments are a two-piece abutment with a titanium base and a ceramic top-half which when cemented together (Shofu MonoCem K020481) constitutes the final finished abutment. Each patient-specific abutment is prescribed by a clinician and manufactured by an authorized milling center validated by Prismatik Dentalcraft Inc. Inclusive® Titanium Abutments are provided non-sterile and intended for single use and prescription use.

Inclusive® Multi-Unit Coping is manufactured from titanium alloy, Ti-6Al-4V ELI conforming to ASTM F136-13(2021) and used in conjunction with the OEM Keystone® Dental PrimaConnex®, Neodent® GM, Straumann® BLX, Implant Direct® Legacy®, Implant Direct® InterActive®, Implant Direct® RePlant® multi-unit abutments. Inclusive® Multi-Unit Coping is bonded with the dental restoration prior to being seated on the multi-unit abutment via a multi-unit prosthetic screw. The non-engaging configuration of the multiunit coping does not have an internal connection feature and seats onto the flat mating surface of the multi-unit abutment. The multi-unit coping is used in combination with screw-retained multi-unit dental prosthetics, e.g. bridges and bars, which are used to reconstruct the function and aesthetics of lost teeth. The multi-unit coping is straight with no angle correction and provided non-sterile. The device is intended for singe use and prescription use.

AI/ML Overview

The provided document is a 510(k) Summary for a dental device (Inclusive® Titanium Abutments). It details the device's technical characteristics and claims substantial equivalence to a predicate device based on non-clinical testing. However, it does not include specific quantitative acceptance criteria or detailed results of a study designed to compare the device performance against such criteria.

The document discusses "performance data" in general terms, referring to several non-clinical tests (Biocompatibility, Mechanical Properties, Sterilization Validation, Shelf Life and Packaging Validation, and Use in MR Environment). It states that these tests were performed to "demonstrate substantial equivalence" and to "address questions related to substantial equivalence based on the differences in technical specifications," but it doesn't present the data in a way that allows for filling out the requested table of acceptance criteria and reported performance.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I answer questions 2 through 9 regarding sample size, data provenance, expert involvement, adjudication, MRMC studies, or training set details, as this information is not present in the provided text.

The document explicitly states:

"Non-clinical testing data are submitted to demonstrate substantial equivalence. No clinical data was included in this submission."

This indicates that clinical trials with human subjects, which would typically involve expert ground truth establishment and detailed performance metrics comparing against specific acceptance criteria, were not part of this submission for substantial equivalence.

The "Mechanical Properties" section mentions:

"Static load and fatigue testing of the implant/abutment assembly was considered according to the FDA Guidance Document, Guidance for Industry and FDA Staff Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments and ISO 14801:2016 standard with the worst-case scenario. The fatigue limit data demonstrated that the subject device has sufficient strength for its intended use."

This implies that there were performance targets based on ISO 14801:2016 for fatigue strength, but the specific acceptance critiera (e.g., minimum fatigue strength in Newtons) and the actual reported performance values are not provided in this summary. It only states that the device "has sufficient strength."

Summary

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Image /page/0/Picture/0 description: The image shows 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 square are the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" below it.

July 12, 2024

Prismatik Dentalcraft, Inc. So Hyun Park Manager - Regulatory Affairs 2144 Michelson Drive Irvine, California 92612

Re: K240240

Trade/Device Name: Inclusive® Titanium Abutments compatible with: Keystone® Dental PrimaConnex®, Neodent® GM, Straumann® BLX, Implant Direct® Legacy®, Implant Direct® InterActive®, Implant Direct® RePlant® Implant Systems Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: June 14, 2024 Received: June 18, 2024

Dear So Hyun Park:

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 (the 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 available 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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

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For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (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 Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.

Submission Number (if known)

K240240

Device Name

Indications for Use (Describe)

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Compatible Implant System: Keystone® Dental PrimaConnex®, Neodent® GM, Straumann® BLX, Implant Direct® Legacy®, Implant Direct® InterActive®, Implant Direct® RePlant®

Compatible Implant Fixtures	Implant Body Diameter	Platform Diameter
Keystone® Dental PrimaConnex®	3.5 mm4.1 mm5.0 mm	SDRDWD
Neodent® GM	3.5 mm3.75 mm4.0 mm4.3 mm5.0 mm7.0 mm	GM
Straumann® BLX	3.5 mm3.75 mm4.0 mm4.5 mm5.5 mm6.5 mm	RBWB
Implant Direct® Legacy®	3.2 mm3.7 mm4.2 mm4.7 mm5.2 mm5.7 mm7.0 mm	3.0 mm3.5 mm4.5 mm5.7 mm
Implant Direct® InterActive®	3.2 mm3.7 mm4.3 mm5.0 mm	3.0 mm3.4 mm
Implant Direct® RePlant®	3.5 mm4.3 mm5.0 mm6.0 mm	3.5 mm4.3 mm5.0 mm6.0 mm

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.

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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."

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Image /page/6/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. On the left is a triangle with different colors. The text "PRISMATIK DENTALCRAFT, INC." is on the right in blue.

510(k) Summary K240240

I. SUBMITTER

Prismatik Dentalcraft, Inc. 2144 Michelson Drive, Irvine, CA 92612, USA

Primary Contact Person: So Hyun Park, Regulatory Affairs Manager, MS Email: so.park@glidewelldental.com Phone: (949) 863-5479

Secondary Contact Person: Maria Wagner, Sr. Regulatory Affairs Manager Email: maria.wagner(@glidewelldental.com Phone: (949) 838-1321

Date Prepared: July 10, 2024

II. DEVICE

Name of Device: Inclusive® Titanium Abutments compatible with: Keystone® Dental PrimaConnex®, Neodent® GM, Straumann® BLX, Implant Direct® Legacy®, Implant Direct® InterActive®, Implant Direct® RePlant® Implant Systems Common Name or Usual Name: Dental Implant Abutment Classification Name: Endosseous Dental Implant Abutment (21 CFR 872.3630) Regulatory Class: Class II Product Code: NHA

III. PREDICATE DEVICE

Primary Predicate

Inclusive® Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant System® EV (K191222)

Reference Devices Inclusive® Titanium Abutment Blanks (K083192) Inclusive® Abutments (K160979) PrimaConnex® Internal Connection Implant System, PrimaConnex® Internal Connection Prosthetics (K051614) Neodent® Implant System - GM Line (K163194) Neodent® Implant System - GM Helix Implants 7.0 (K201225) Straumann® BLX Implant System (K173961) Straumann® BLX Line Extension - Implants, SRAs and Anatomic Abutments (K181703) Straumann® BLX Ø3.5 mm Implants (K191256) Straumann® BLX Implant System (K210855) Straumann® BLX Line Extension - New Abutments (K190040)

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Image /page/7/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. On the left is a triangle with a color gradient that transitions from blue to pink to yellow. To the right of the triangle is the text "PRISMATIK" in a larger font, with "DENTALCRAFT, INC." below it in a smaller font. The text is in a blue color that matches the blue in the triangle.

Legacy Abutment System (K060063) Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants; Legacy2, Legacy3, Legacy4 fixture-mounts (K192221) InterActive®/SwishPlus2 Implant System (K130572) Spectra System (K061319)

IV. DEVICE DESCRIPTION

Inclusive® Multi-Unit Coping is manufactured from titanium alloy, Ti-6Al-4V ELI conforming to ASTM F136-13(2021) and used in conjunction with the Keystone® Dental PrimaConnex®, Neodent® GM, Straumann® BLX, Implant Direct® Legacy®, Implant Direct® InterActive®, Implant Direct® RePlant® multi-unit abutments. Inclusive® Multi-Unit Coping is bonded with the dental restoration prior to being seated on the multi-unit abutment via a multi-unit prosthetic screw. The non-engaging configuration of the multiunit coping does not have an internal connection feature and seats onto the flat mating surface of the multi-unit abutment. The multi-unit coping is used in combination with screw-retained multi-unit dental prosthetics, e.g. bridges and bars, which are used to reconstruct the function and aesthetics of lost teeth. The multi-unit coping is straight with no angle correction and provided non-sterile. The device is intended for singe use and prescription use.

V. INDICATIONS FOR USE

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Image /page/8/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. The logo consists of a triangle on the left side with a gradient of colors, including pink, red, yellow, green, blue, and purple. To the right of the triangle is the text "PRISMATIK" in a larger, bold, blue font, with "DENTALCRAFT, INC." below it in a smaller, bold, blue font.

Compatible Implant Fixtures	Implant Body Diameter	Implant Platform Diameter
Keystone® DentalPrimaConnex®	3.5 mm	SD
	4.1 mm	RD
	5.0 mm	WD
Neodent® GM	3.5 mm	GM
	3.75 mm
	4.0 mm
	4.3 mm
	5.0 mm
	7.0 mm
Straumann® BLX	3.5 mm	RB
	3.75 mm
	4.0 mm
	4.5 mm
	5.5 mm	WB
	6.5 mm
Implant Direct® Legacy®	3.2 mm	3.0 mm
	3.7 mm	3.5 mm
	4.2 mm
	4.7 mm	4.5 mm
	5.2 mm
	5.7 mm	5.7 mm
	7.0 mm
Implant Direct® InterActive®	3.2 mm	3.0 mm
	3.7 mm
	4.3 mm	3.4 mm
	5.0 mm
Implant Direct® RePlant®	3.5 mm	3.5 mm
	4.3 mm	4.3 mm
	5.0 mm	5.0 mm
	6.0 mm	6.0 mm

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Image /page/9/Picture/0 description: The image shows the logo for PRISMATIK DENTALCRAFT, INC. The logo consists of a colorful triangle on the left and the company name on the right. The triangle is divided into sections of different colors, including pink, blue, and yellow. The company name is written in blue, with "PRISMATIK" on the top line and "DENTALCRAFT, INC." on the bottom line.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS VI.

TechnologicalCharacteristics	Subject Device(K231097)	Predicate Device(K191222)	Comparison
Device Name	Inclusive® Titanium Abutments compatible with:Keystone® Dental PrimaConnex®, Neodent® GM,Straumann® BLX, Implant Direct® Legacy®, ImplantDirect® InterActive®, Implant Direct® RePlant®Implant Systems	Inclusive® Titanium Abutments compatiblewith: Dentsply Implants Astra Tech ImplantSystem® EV	N/A
Manufacturer	Prismatik Dentalcraft, Inc.	Prismatik Dentalcraft, Inc.	Identical
Product Code	NHA	NHA	Identical
Prescription Device	Yes	Yes	Identical
Intended Use	Inclusive® Abutments are intended for use as an aid inprosthetic rehabilitation.	Inclusive® Abutments are intended for use as anaid in prosthetic rehabilitation.	Identical
Indications for Use	Inclusive® Titanium Abutments are premanufacturedprosthetic components connected to endosseous dentalimplants in edentulous or partially edentulous maxillaor mandible to provide support for cement-retained orscrew-retained prosthetic restorations.All digitally designed abutments for use withInclusive® Titanium Abutments for CAD/CAM areintended to be sent to a Prismatik Dentalcraft validatedmilling center for manufacture.Compatible Implant Systems: Keystone® DentalPrimaConnex®, Neodent® GM, Straumann® BLX,Implant Direct® Legacy®, Implant Direct®InterActive®, Implant Direct® RePlant®	Inclusive® Titanium Abutments arepremanufactured prosthetic componentsconnected to endosseous dental implants inedentulous or partially edentulous maxilla ormandible to provide support for cement-retainedor screw-retained prosthetic restorations.All digitally designed abutments for use withInclusive® Titanium Abutments for CAD/CAMare intended to be sent to a Prismatik Dentalcraftvalidated milling center for manufacture.Compatible Implant System: Dentsply ImplantsAstra Tech Implant System® EV	Identical exceptfor compatibleplatforms

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Image /page/10/Picture/0 description: The image contains the logo for Prismatik Dentalcraft, Inc. On the left is a triangular prism with a color gradient. The text "PRISMATIK DENTALCRAFT, INC." is on the right, with "PRISMATIK" on the top line and "DENTALCRAFT, INC." on the bottom line.

TechnologicalCharacteristics	Subject Device(K231097)			Predicate Device(K191222)			Comparison
	Compatible ImplantFixtures	Implant BodyDiameter	ImplantPlatformDiameter	Compatible ImplantFixtures	ImplantBodyDiameter	ImplantPlatformDiameter
	Keystone® DentalPrimaConnex®	3.5 mm	SD	OsseoSpeed® EV3.0S	3.0 mm	3.0 mm
		4.1 mm	RD
		5.0 mm	WD
	Neodent® GM	3.5 mm	GM	OsseoSpeed® EV3.6Ss	3.6 mm	3.6 mm
		3.75 mm
		4.0 mm		OsseoSpeed® EV4.2S	4.2 mm	4.2 mm
		4.3 mm
		5.0 mm		OsseoSpeed® EV4.2C	3.6 mm	4.2 mm
		7.0 mm
	Straumann® BLX	3.5 mm	RB	OsseoSpeed® EV4.8S	4.8 mm	4.8 mm
		3.75 mm
		4.0 mm		OsseoSpeed® EV4.8C	4.2 mm	4.8 mm
		4.5 mm
		5.5 mm	WB	OsseoSpeed® EV5.4S	5.4 mm	5.4 mm
		6.5 mm
	Implant Direct®Legacy®	3.2 mm	3.0 mm
		3.7 mm	3.5 mm
		4.2 mm
		4.7 mm	4.5 mm
		5.2 mm
		5.7 mm	5.7 mm
		7.0 mm
	Implant Direct®InterActive®	3.2 mm	3.0 mm
		3.7 mm
		4.3 mm	3.4 mm
		5.0 mm
	Implant Direct®RePlant®	3.5 mm	3.5 mm
		4.3 mm	4.3 mm
		5.0 mm	5.0 mm
		6.0 mm	6.0 mm
TechnologicalCharacteristics			Subject Device(K231097)		Predicate Device(K191222)	Comparison
Design Characteristics		Abutment&Screw	Ti-6Al-4V ELI		Ti-6Al-4V ELI	Identical
		Multi-UnitCoping & Screw	Ti-6Al-4V ELI		Ti-6Al-4V ELI	Identical
	Material	Coping/Superstructure	Y-TZP (ISO 13356)		Y-TZP (ISO 13356)	Identical
		Cement	Shofu MonoCem resin cement (K020481)		Shofu MonoCem resin cement (K020481)	Identical
		Connection	Implant	Connection Design	Taper followed with a six-position indexingconnection feature	Differentconnectiondesign
			Keystone® DentalPrimaConnex®	Six lobed connection
			Neodent® GM	Grand Morse™ connection
			Straumann® BLX	TorcFit™ connection
			Implant Direct®Legacy®	Hexagonal connection
			Implant Direct®InterActive®	Hexagonal connection
			Implant Direct®RePlant®	Tri-Lobe connection
			Titanium AbutmentBlank	Provided in 9.4mm diameter; To machine a patientspecific, engaging, one-piece abutment		Provided in 9.4mm diameter; To machine apatient-specific, engaging, one-piece abutment	Identical
			Prosthetic PostHeight	4.0 mm minimum		4.0 mm minimum	Identical
			Gingival Height	0.5 mm minimum		0.5 mm minimum	Identical
				6.0 mm maximum		6.0 mm maximum	Identical
		Angulation	0° - 30°		0° - 20°	Increasedangulationrange,supported byfatigue testing
			ProstheticAttachment	Cement-retained, Screw-retained		Cement-retained, Screw-retained	Identical
				Restoration Types	Single-unit, Multi-unit		Single-unit, Multi-unit	Identical
			Titanium Abutment	Engaging/Non-Engaging two-piece abutment		Engaging/Non-Engaging two-piece abutment	Identical

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Image /page/11/Picture/0 description: The image contains the logo for Prismatik Dentalcraft, Inc. On the left side of the logo is a triangle with different colors. The right side of the logo contains the text "PRISMATIK DENTALCRAFT, INC." in blue.

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Image /page/12/Picture/0 description: The image contains the logo for Prismatik Dentalcraft, Inc. On the left is a triangular prism with a color gradient. To the right of the prism is the company name, "PRISMATIK DENTALCRAFT, INC." in blue font.

TechnologicalCharacteristics	Subject Device(K231097)	Predicate Device(K191222)	Comparison
Prosthetic PostHeight	4.0 mm minimum	4.0 mm minimum	Identical
Margin Height	0.5 mm minimum	0.5 mm minimum	Identical
Gingival Height	6.0 mm maximum	6.0 mm maximum	Identical
Angulation	0°	0°	Identical
ProsthesisAttachment	Cement-retained, Screw-retained	Cement-retained, Screw-retained	Identical
Restoration Type	Single-unit, Multi-unit	Single-unit, Multi-unit	Identical
Multi-Unit Coping	Prefabricated coping to be used in conjunction with theOEM multi-unit abutment.	N/A	The predicatedevice does nothave multi-unitcoping.
Angulation	0°	N/A	The predicatedevice does nothave multi-unitcoping. Thefunctionality ofthe subjectdevice issupported bydimensionalanalysis andreverseengineeringanalysis.
ProstheticAttachment	Screw-retained multi-unit dental prosthesis, e.g.bridges and bars	N/A	The predicatedevice does nothave multi-unitcoping. Thefunctionality ofthe subjectdevice issupported by
TechnologicalCharacteristics	Subject Device(K231097)	Predicate Device(K191222)	Comparison
Restoration Type	Multi-unit	N/A	dimensionalanalysis andreverseengineeringanalysis.The predicatedevice does nothave multi-unitcoping. Thefunctionality ofthe subjectdevice issupported bydimensionalanalysis andreverseengineeringanalysis.

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Image /page/13/Picture/0 description: The image contains the logo for Prismatik Dentalcraft, Inc. On the left is a triangular prism with a color gradient. The text "PRISMATIK DENTALCRAFT, INC." is on the right, with "PRISMATIK" on the top line and "DENTALCRAFT, INC." on the bottom line.

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Image /page/14/Picture/0 description: The image contains the logo for Prismatik Dentalcraft, Inc. The logo consists of a triangle with a gradient of colors, ranging from pink to blue to yellow. To the right of the triangle is the text "PRISMATIK DENTALCRAFT, INC." in a blue sans-serif font. The text is stacked, with "PRISMATIK" on the top line and "DENTALCRAFT, INC." on the bottom line.

DETERMINATION OF SUBSTANTIAL EQUIVALENCE

The subject device is substantially equivalent to the primary predicate device (K191222) listed above in intended use, material, design principles and technological characteristics. The subject device and the primary predicate device (K191222) include prefabricated, precision interface (implant/abutment connection) abutments that are manufactured from titanium alloy conforming to ASTM F136-13(2021). The subject device and the primary predicate device (K191222) include Inclusive® Titanium Abutment Blanks intended to be used to fabricate one-piece, all-titanium, patient-specific abutments using CAD/CAM technology and Inclusive® Titanium Abutments 4.5mmH intended to be used for support of fabricated crowns/bridges or zirconia copings. Inclusive® Titanium Abutments are two-piece abutment with a titanium base and a ceramic top half. Each patient-specific abutment is individually prescribed by the clinician and manufactured by Prismatik Dentalcraft, Inc. or a qualified validated milling center.

The Indications for Use Statement (IFUS) for the subject device is substantially equivalent to that of the primary predicate device (K191222) except the compatible implant system due to different implant connection. Both devices have intended use as endosseous dental implant abutments for the support of a prosthesis to restore chewing function.

The subject device designs are substantially equivalent to the corresponding design of the primary predicate device (K191222), including titanium blank abutments and titanium base abutments (engaging and non-engaging). The subject device and the primary predicate device (K191222) are for single-unit or multiple-unit restorations and for cement-retained or screw-retained prostheses. Both devices have internal implant interface connections and are made of titanium alloy Ti-6Al-4V conforming to ASTM F136-13(2021) (abutments and abutment screws), and the titanium base abutments are to be used with zirconia superstructures.

The subject device includes designs for abutment angulation up to 30°; this angulation range is similar to the primary predicate device (K191222), but increased angulation range from 20° to 30°. The subject device is compatible with the following OEM implant systems, Keystone® Dental PrimaConnex® (K051614), Neodent® GM (K163194, K201225), Straumann® BLX (K173961, K181703, K191256, K210855), Implant Direct® Legacy® (K192221), Implant Direct® InterActive® (K130572), Implant Direct® RePlant® (K061319), and the compatibility of the subject device and the OEM implants was established by dimensional analysis and reverse engineering analysis regarding specific critical dimensions. When the subject device is used according to its labeling, this difference does not impact safety or effectiveness. Furthermore, mechanical performance testing was performed according to ISO 14801:2016, Dentistrv - Implants - Dynamic loading test for endosseous dental implants and demonstrated that the subject device has sufficient strength for its intended use.

The subject device also inclusive® Multi-Unit Coping, which is used in conjunction with the OEM Keystone® Dental PrimaConnex® (K051614), Neodent® GM

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Image /page/15/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. The logo consists of a triangle on the left side, filled with a gradient of colors. To the right of the triangle is the text "PRISMATIK DENTALCRAFT, INC." in a blue sans-serif font. The text is arranged in two lines, with "PRISMATIK" on the top line and "DENTALCRAFT, INC." on the bottom line.

(K163194), Straumann® BLX (K190040), Implant Direct® Legacy® (K060063), Implant Direct® InterActive® (K130572), Implant Direct® RePlant® (K061319) multi-unit abutments. The Multi-Unit Coping has not been subjected to static load and fatigue testing since it is provided straight with no angle correction. The intended use of the Multi-Unit Coping is to support a multi-unit restoration that will have other implant anchors. Therefore, the Multi-Unit Coping is always used in splinted applications reducing the effect of compressive and shear forces. The compatibility of the subject device and the OEM multiunit abutments was established by dimensional analysis and reverse engineering analysis regarding specific critical dimensions. When the subject device is used according to its labeling, there is no concern on safety and effectiveness of the device.

The subject device is provided non-sterile and to be steam sterilized by the end-user. The validated moist heat sterilization method according to ISO 17665-1:2006, Sterilization of health care products – Moist heat – Requirements for the development, validation and routine control of a sterilization process for medical devices and ISO/TS 17665-2:2009, Sterilization of health care products – Moist heat – Part 2: Guidance on the application of ISO 17665-1 is the same as the primary predicate device (K191222), and the reference devices K083192 and K160979. Substantial equivalence of the subject device components in terms of biocompatibility is supported by the fact that materials are identical in formulation, processing, component interactions, and storage conditions to the primary predicate device (K191222) and the reference device (K160979). The biological evaluation was also performed on the subject device and concluded that there is no biocompatibility concern.

VII. PERFORMANCE DATA

Non-clinical testing data are submitted to demonstrate substantial equivalence. No clinical data was included in this submission.

Biocompatibility Evaluation

Biocompatibility evaluation was conducted by following the FDA Guidance Document, Use of International Standard ISO 10993-1, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process and concluded that there is no biocompatibility concern. The subject device has the same material and manufacturing process at the same manufacturing facility as the primary predicate device (K191222) and the reference device (K169079); therefore, additional biocompatibility testing was not conducted. Cytotoxicity testing according to ISO 10993-5:2009, Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity was referenced from K169079 to demonstrate the biocompatibility of the final finished device consisting of the titanium abutment, zirconia coping and cement. Biological evaluation was used to address questions related to substantial equivalence between the subject device and the primary predicate device (K191222) in terms of biocompatibility.

Mechanical Properties

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Image /page/16/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. The logo consists of a triangle on the left side, filled with a gradient of colors. To the right of the triangle is the text "PRISMATIK DENTALCRAFT, INC." in a blue sans-serif font. The text is arranged in two lines, with "PRISMATIK" on the top line and "DENTALCRAFT, INC." on the bottom line.

Static load and fatigue testing of the implant/abutment assembly was considered according to the FDA Guidance Document, Guidance for Industry and FDA Staff Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments and ISO 14801:2016 standard with the worst-case scenario. The fatigue limit data demonstrated that the subject device has sufficient strength for its intended use. Reverse engineering of OEM implant bodies, OEM abutments, and OEM abutment screws was conducted to confirm compatibility. The results of the mechanical testing were used to address questions related to substantial equivalence based on the differences in technical specifications between the subject device and the primary predicate device (K191222).

Sterilization Validation

The subject device is provided non-sterile intended to be steam sterilized by the end user with the same parameters as the primary predicate device (K191222) as validated by ISO 17665-1:2006 and ISO/TS 17665-2:2009. The subject device has the same material and manufacturing process at the same manufacturing facility as the primary predicate device (K191222) and the reference device (K160979); therefore, additional sterilization validation was not conducted. Sterilization validation according to ISO 17665-1:2006 and ISO/TS 17665-2:2009 were referenced from K083192 and K160979. The results of the previous testing were used to address questions related to substantial equivalence based on the differences in technical specifications between the subject device and the primary predicate device (K191222).

Shelf Life and Packaging Validation

The subject device performance is not adversely affected by aging because the subject device is made from titanium alloy conforming to ASTM F136-13(2021); this material is known to be stable in air at room temperature for an indefinite period. Shelf-life is not applicable because of the low likelihood of time-dependent product degradation. Packaging validation according to ASTM D4169-22, Standard Practice for Performance Testing of Shipping Containers and Systems was conducted to ensure that the packaging configurations for the subject device are suitable to withstand the distribution environment. It was determined that the packaging for the subject device is suitable for use. The results of the testing were used to address questions related to substantial equivalence based on differences in product packaging between the subject device and the primary predicate device (K191222).

Use in MR Environment

Non-clinical MR review was performed to evaluate the metallic devices in the MR 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 subject device components and material composition.

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Image /page/17/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. The logo consists of a colorful triangle on the left and the company name on the right. The triangle is divided into sections of different colors, including pink, red, yellow, green, and blue. The company name is written in blue, with "PRISMATIK" on the top line and "DENTALCRAFT, INC." on the bottom line.

Rationale addressed parameters per the FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment".

CONCLUSION VIII.

Based on the technological characteristics and non-clinical test data included in this submission, the subject device has been shown to be substantially equivalent to the predicate device (K191222).

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.)