The Zfx Abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandbular arch to provide support for prosthetic restorations.

All digitally designed custom abutments or superstructures and/or hybrid abutment crowns for use with Zfx TiBase or Pre-Milled Blank Abutments are intended to be sent to a Zfx validated milling center for manufacture.

The Zfx TiBase abutments for the 03.25 mm Certain implant bodies, and 03.1 mm Eztetic implant bodies are indicated for maxillary lateral and mandibular central/lateral incisors only.

Device Description

The subject device, Zfx Abutments, consists of two abutment types, a TiBase and a Pre-milled Abutment Blank, with corresponding retaining screws. Zfx Abutments are offered in a variety of connections compatible with ZimVie dental implants. All abutments and screws are provided non-sterile.

TiBase Abutments: Subject device TiBases are two-piece abutments. The pre-manufactured titanium base component is the apical part. The coronal part of the two-piece abutment is a CAD/CAM designed and manufactured superstructure. The subject device TiBase abutments are available in hexed/engaging and non-hexed/nonengaging configurations. The engaging TiBase abutments are intended for single and multi-unit restorations and the non-engaging TiBases are intended for multi-unit restorations. The superstructure is intended to be manufactured at a Zfx validated milling center.

Pre-milled Abutment Blanks: The Pre-milled Abutment Blank is a cylindrical titanium alloy abutment designed for patient-specific abutment fabrication with CAD/CAM technology. The patient-specific abutment milled from a Pre-milled Abutment Blank is secured directly to the implant using a retaining screw. Pre-milled Abutment Blanks are available in an engaging/hexed design only for single-unit and multi-unit restorations.

Retaining Screws: Corresponding retaining screws are packaged with the abutment and replacement screws are available individually. All screws are compatible with the corresponding ZimVie dental implants.

Material Composition: All subject device abutments are made of titanium alloy Ti-6Al-4V ELI conforming to ASTM F136. Screws are made of either titanium alloy Ti-6A1-4V ELI conforming to ASTM F136, or Gold-Tite® screws with stainless steel conforming to ASTM F138. Gold-Tite screws have a gold-plating conforming to ASTM B488 and ASTM B571. Zirconia superstructures for use with the TiBase Abutments are made of zirconia conforming to ISO 13356.

AI/ML Overview

The provided text is an FDA 510(k) clearance letter for Zfx Abutments, and as such, it focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and supporting data in the way a clinical study report or a formal performance evaluation report would.

Therefore, the information required to answer many of the questions regarding acceptance criteria, sample sizes, expert involvement, and ground truth establishment is not present in this document. The document primarily outlines the device's technical specifications, indications for use, and a comparison to predicate devices, supported by non-clinical testing data (mechanical testing, biocompatibility, sterilization, etc.).

However, I can extract the information that is available and explain why other requested details are missing.

Acceptance Criteria and Device Performance (Based on "Equivalence to Marketed Devices" and "Performance Data" sections):

This document describes a substantial equivalence submission, meaning the acceptance criteria are primarily demonstrated by showing the device is as safe and effective as a legally marketed predicate device. The performance is assessed through non-clinical testing to ensure it meets established standards comparable to the predicate.

Acceptance Criterion (Implicit for Substantial Equivalence)	Reported Device Performance (Non-Clinical/Design)
Indications for Use Equivalence	"Zfx Abutments (subject device) are substantially equivalent in design, function, material, and Indications for Use to the Primary Predicate, DESS Dental Smart Solutions abutments cleared in K222288. All are intended for use with endosseous dental implants in the maxilla and mandible to provide support for single and multi-unit restorations."
Material Equivalence	"All subject device abutments are made of titanium alloy Ti-6Al-4V ELI conforming to ASTM F136." "Screws are made of either titanium alloy Ti-6A1-4V ELI conforming to ASTM F136, or Gold-Tite® screws with stainless steel conforming to ASTM F138." "Zirconia superstructures for use with the TiBase Abutments are made of zirconia conforming to ISO 13356." This is compared to comparable materials in the predicate.
Product Design and Manufacturing Process Equivalence	"All digitally designed subject device abutments and primary predicate abutments are to a validated milling center for manufacture. Subject device abutments are similar in range of sizes, connections, and technological characteristics to the DESS Dental Smart Solutions, K22288." "Design parameters for the TiBase CAD/CAM zirconia superstructure are listed in the following tables (Tables 2-5)." "Design parameters for the CAD/CAM patient-specific abutment using a Pre-milled Abutment Blank are included in Table 6."
Sterilization Efficacy (Non-clinical)	"sterilization validation according to ISO 17665-1"
Biocompatibility (Non-clinical)	"biocompatibility testing according to ISO 10993-1 Table A-1, ISO 10993-5, and ISO 10993-10"
Reprocessing Validation (Non-clinical)	"reprocessing validation according to ISO 17665-2"
Mechanical Strength/Fatigue (Non-clinical)	"mechanical testing according to ISO 14801 to determine that the subject device has sufficient strength for its intended use."
MR Safety (Non-clinical)	"MR Safety testing was conducted according to ASTM F2052, ASTM F2213, ASTM F2182, and ASTM F2119 for a determination of MR Conditional."
Compatibility with Existing Systems	"reverse engineering analysis to confirm compatibility with the Sirona inCoris Meso Blocks" (for TiBase).

Missing Information and Explanations:

Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not provided. This document details a 510(k) submission based on non-clinical testing for substantial equivalence, not a clinical trial or performance study with human data. The "Performance Data" section explicitly states: "No clinical data were included in this submission." Therefore, there is no "test set" in the context of clinical images or patient data to analyze. The "samples" used were physical samples for mechanical, sterilization, and biocompatibility testing. The data provenance would be from laboratory tests.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Not applicable/Not provided. As no clinical data or clinical "test set" was used, there was no need for expert adjudication to establish ground truth from patient data. The ground truth for mechanical and material properties is established by engineering specifications and industry standards.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/None. No clinical test set to adjudicate.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device (Zfx Abutments) is a physical dental implant component, not an AI software/device. Therefore, an MRMC study or AI assistance is not relevant to its performance evaluation for this submission.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. As above, this is a physical medical device, not an algorithm or AI.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for demonstrating substantial equivalence for this device relies on engineering specifications, material standards (e.g., ASTM, ISO), mechanical test results (e.g., forces to fracture), and comparative analysis with the predicate device's established safe and effective performance. There is no clinical outcomes ground truth cited here.
The sample size for the training set:
- Not applicable. This refers to a dataset for training an AI model. This device is not an AI/software.
How the ground truth for the training set was established:
- Not applicable. As above, no training set for an AI model.

In summary, this document is a regulatory clearance letter focused on substantial equivalence for a physical dental device. The "study" proving it meets acceptance criteria consists of various non-clinical bench tests and a comparison to a predicate device's specifications and performance, rather than a clinical study with patients or an AI model's performance evaluation.

Summary

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

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 1, 2024

GmbH - a company of ZimVie Ana Leitão Regulatory & Compliance Senior Specialist Kopernikusstraße 15 Dachau. 85221 GERMANY

Re: K231915

Trade/Device Name: Zfx Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: January 31, 2024 Received: February 5, 2024

Dear Ana Leitão:

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.

{1}------------------------------------------------

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.

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

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

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

Indications for Use

510(k) Number (if known) K231915

Device Name Zfx Abutments

Indications for Use (Describe)

The Zfx Abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandbular arch to provide support for prosthetic restorations.

Table I Compatible Implant Systems
Compatible Implant	Platform Ø (mm)
Certain (Tapered and Parallel Walled),T3, T3 Pro	3.4
	4.1
	5.0
	6.0
Tapered Screw-Vent, Trabecular Metal	3.5
	4.5
	5.7
TSX	2.9
	3.5
	4.5
Eztetic	2.9

Table 1 Compatible Implant Systems

The Zfx TiBase abutments for the 03.25 mm Certain implant bodies, and 03.1 mm Eztetic implant bodies are indicated for maxillary lateral and mandibular central/lateral incisors only.

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

X 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."

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

Zfx Abutments 510(k) Summary March 1st, 2024 [510(k) Number K231915]

Administrative Information

Manufacturer Name	Zfx GmbH
	Kopernikusstraße 15, 85221 Dachau, Germany
Telephone	+49 162 3088254
Official Contact	Ana Leitão, Regulatory & Compliance Senior Specialist
	Email: ana.leitao@zimvie.com

Device Name and Classification

Trade/Proprietary Name	Zfx Abutments
Common Name	Dental Implant Abutment
Regulation Number	21 CFR 872.3630
Regulation Name	Endosseous Dental Implant Abutment
Regulatory Class	Class II
Product Code	NHA
Classification Panel	Dental Products Panel
Reviewing Division	Division of Dental Devices

Predicate Device Information

Primary Predicate Device K22288, DESS Dental Smart Solutions, Terrats Medical SL

Reference Devices

K052648, Modification 3i Patient-Specific Dental Abutment and Overdenture Bar, 3i Implant Innovations, Inc. K100993, Inclusive Titanium Abutments for Astra OsseoSpeed, Prismatik Dental Craft Inc. K213672, T3 Pro Implants, Biomet 3i LLC K130436, Multilink Hybrid Abutment Cement, Ivoclar Vivadent K092341, Biomet 3i Low Profile Abutments K063341, 3i OSSEOTITE Certain(R) Dental Implants, Implant Innovations, Inc. K061629, CERTAIN PREVAIL DENTAL IMPLANT, Implant Innovations, Inc. K063286, OSSEOTITE; OSSEOTITE NT; XP; TG OSSEOTITE, Implant Innovations, Inc. K100724, OSSEOTITE II MODEL XIFOSSXXX, Biomet 3i LLC K111216, OSSEOTITE 2 DENTAL IMPLANTS, Biomet 3i LLC K130949, CP4 OSSEOTITE CERTAIN DENTAL IMPLANTS, Biomet 3i LLC K142082, Zimmer 3.1mm Dental Implant [Eztetic], Zimmer Dental, Inc. K133339, Tapered Screw Vent T & M Implants, Zimmer Dental, Inc. K113753, Tapered Screw-Vent(R) X Implant, Zimmer Dental, Inc. K132258, Trabecular Metal Implant, Zimmer Dental, Inc. K122300, 3i T3 Dental Implant, Biomet 3i LLC

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

K220978, TSX Implants, Biomet 3i LLC

K212730. BellaTek Encode Emergence Healing Abutments, Biomet 3i LLC

Indications for Use Statement

The Zfx Abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for prosthetic restorations.

Compatible Implant	Platform Ø (mm)
Certain (Tapered and Parallel Walled), T3, T3 Pro	3.4
Certain (Tapered and Parallel Walled), T3, T3 Pro	4.1
Certain (Tapered and Parallel Walled), T3, T3 Pro	5.0
Certain (Tapered and Parallel Walled), T3, T3 Pro	6.0
Tapered Screw-Vent, Trabecular Metal	3.5
Tapered Screw-Vent, Trabecular Metal	4.5
Tapered Screw-Vent, Trabecular Metal	5.7
TSX	2.9
TSX	3.5
TSX	4.5
Eztetic	2.9

Table 1 Compatible Implant Systems

The Zfx TiBase abutments for the Ø3.25 mm Certain implant bodies, and Ø3.1 mm Eztetic implant bodies are indicated for maxillary lateral and mandibular central/lateral incisors only.

Subject Device Description

TiBase Abutments

Subject device TiBases are two-piece abutments. The pre-manufactured titanium base component is the apical part. The coronal part of the two-piece abutment is a CAD/CAM designed and manufactured superstructure. The subject device TiBase abutments are available in hexed/engaging and non-hexed/nonengaging configurations. The engaging TiBase abutments are intended for single and multi-unit restorations and the non-engaging TiBases are intended for multi-unit restorations.

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

The superstructure is intended to be manufactured at a Zfx validated milling center. Zfx recommends the use of Ivoclar Vivadent Multilink Hybrid Abutment Cement

Design parameters for the TiBase CAD/CAM zirconia superstructure are listed in the following tables:

Table 2 Design parameters for manufacturing zirconia superstructure and/or hybrid crowns compatible with Certain (Tapered and Parallel Walled), T3, T3 Pro implant systems

DESIGN PARAMETERS FOR MANUFACTURING ZIRCONIA SUPERSTRUCTURES COMPATIBLEWITH CERTAIN IMPLANT SYSTEMS
Superstructure Parameters	Superstructure Parameter Values
	Min.	Max.
Superstucture GingivalHeight (A)	0.3mm TiBaseCollar Height		5.75mm
	1.3mm TiBaseCollar Height	0.25mm	4.7mm
	2.6mm TiBaseCollar Height		3.4mm
Angulation (B)		0°	30°
Wall Thickness (C)		0.3mm	N/A
Implant Platform Diameter		3.5mm	5.0mm

Table 3 Design parameters for manufacturing zirconia superstructure and/or hybrid crowns compatible with Tapered Screw-Vent, Trabecular Metal implant systems

DESIGN PARAMETERS FOR MANUFACTURING ZIRCONIA SUPERSTRUCTURES COMPATIBLEWITH TSV IMPLANT SYSTEMS
Superstructure Parameters	Superstructure Parameter Values
	Min.	Max.
SuperstructureGingival Height (A)	0.3mm TiBaseCollar Height		5.75mm
	1.3mm TiBaseCollar Height	0.25mm	4.3mm
	2.6mm TiBaseCollar Height		3.4mm
Angulation (B)	0°		30°
Wall Thickness (C)	0.3mm		N/A
Implant Platform Diameter	3.5mm		5.7mm

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

Table 4 Design parameters for manufacturing zirconia superstructure and/or hybrid crowns compatible with TSX implant system

DESIGN PARAMETERS FOR MANUFACTURING ZIRCONIA SUPERSTRUCTURES COMPATIBLEWITH TSX IMPLANT SYSTEMS
		Superstructure Parameter Values
Superstructure Parameters		Min.	Max.
	0.3mm TiBaseCollar Height		5.75mm
	1.3mm TiBaseCollar Height		4.7mm
SuperstructureGingival Height (A)	2.6mm TiBaseCollar Height	0.25mm	3.4mm
	1.0mm TiBaseCollar Height		5.0mm
	1.7mm TiBaseCollar Height		4.3mm
Angulation (B)		0°	30°
Wall Thickness (C)		0.3mm	N/A
Implant Platform Diameter		2.9mm	4.5mm

Table 5 Design parameters for manufacturing zirconia superstructure and/or hybrid crowns compatible with Eztetic implant systems

DESIGN PARAMETERS FOR MANUFACTURING ZIRCONIA SUPERSTRUCTURES COMPATIBLEWITH EZTETIC IMPLANT SYSTEMS
Superstructure Parameters		Superstructure Parameter ValuesMin.	Max.
SuperstructureGingival Height (A)	1.0 mm TiBase CollarHeight		5.0 mm
	1.7 mm TiBase CollarHeight	0.25mm	4.3 mm
	2.6 mm TiBase CollarHeight		3.4 mm
Angulation (B)		0°	30°
Wall Thickness (C)		0.3mm	N/A
Implant Platform Diameter		2.9mm	N/A

The post height of an abutment is the cementable post measured above the gingival margin of the final abutment design including that of the ceramic top-half. The minimum allowable post height for patient-matched Zfx abutments intended for single-unit loading is 4.0 mm.

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

Pre-milled Abutment Blanks

The Pre-milled Abutment Blank is a cylindrical titanium alloy abutment designed for patient-specific abutment fabrication with CAD/CAM technology. The patient-specific abutment milled from a Pre-milled Abutment Blank is secured directly to the implant using a retaining screw. Pre-milled Abutment Blanks are available in an engaging/hexed design only for single-unit and multi-unit restorations.

Design parameters for the CAD/CAM patient-specific abutment using a Pre-milled Abutment Blank are included in the following table:

Description	Min.	Max.
Gingival Margin Height (Collar)	0.25 mm	6.0 mm
Platform Diameter	2.9mm	6.0mm
Angulation	0°	30°
Wall Thickness	0.5mm	N/A
Post Height	4.0 mm	N/A

Table 6 - Design parameters for manufacturing Pre-milled Blank custom abutments

Retaining Screws

Corresponding retaining screws are packaged with the abutment and replacement screws are available individually. All screws are compatible with the corresponding ZimVie dental implants.

Material Composition

All subject device abutments are made of titanium alloy Ti-6Al-4V ELI conforming to ASTM F136.

Screws are made of either titanium alloy Ti-6A1-4V ELI conforming to ASTM F136, or Gold-Tite® screws with stainless steel conforming to ASTM F138. Gold-Tite screws have a gold-plating conforming to ASTM B488 and ASTM B571.

Zirconia superstructures for use with the TiBase Abutments are made of zirconia conforming to ISO 13356.

Performance Data

Non-clinical testing data submitted to demonstrate substantial equivalence includes: sterilization validation according to ISO 17665-1; biocompatibility testing according to ISO 10993-1 Table A-1, ISO 10993-5, and ISO 10993-10; reverse engineering analysis to confirm compatibility with the Sirona inCoris Meso Blocks; reprocessing validation according to ISO 17665-2, and mechanical testing according to ISO 14801 to determine that the subject device has sufficient strength for its intended use. MR Safety testing was conducted according to ASTM F2052, ASTM F2213, ASTM F2182, and ASTM F2119 for a determination of MR Conditional.

No clinical data were included in this submission.

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

Equivalence to Marketed Devices

Zfx Abutments (subject device) are substantially equivalent in design, function, material, and Indications for Use to the Primary Predicate, DESS Dental Smart Solutions abutments cleared in K222288. All are intended for use with endosseous dental implants in the maxilla and mandible to provide support for single and multi-unit restorations.

All digitally designed subject device abutments and primary predicate abutments are to a validated milling center for manufacture. Subject device abutments are similar in range of sizes, connections, and technological characteristics to the DESS Dental Smart Solutions, K22288. Implant/abutment compatibility for the subject device is substantially equivalent to the primary predicate.

Material for the superstructure of both the subject device and the predicate device is zirconia conforming to ISO 13356. The cement recommended for bonding of superstructures for both the subject device and the predicate device is Multilink Hybrid Abutment Cement.

Subject Device	Indications for Use Statement
Zfx Abutments	The Zfx Abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandbular arch to providesupport for prosthetic restorations.
		All digitally designed custom abutments or superstructures and/or hybrid abutment crowns for use with Zfx TiBase or Pre-Milled BlankAbutments are intended to be sent to a Zfx validated milling center for manufacture.Table 1 Compatible Implant Systems

			Compatible Implant System	Platform Ø (mm)
				3.4
			Certain (Tapered and Parallel Walled),	4.1
			T3, T3 Pro
				6.0

			Tapered Screw-Vent,Trabecular Metal	4.55.7


			TSX	3.5
				4.5
			Eztetic	2.9
	mandibular central/lateral incisors only.				The Zfx TiBase abutments for the 03.25 mm Certain implant bodies are indicated for maxillary lateral and
Primary PredicateDevice
K22288	DESS Dental Smart Solutions abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandbular
DESS DentalSmart Solutions	arch to provide support for prosthetic restorations.
	validated milling center for manufacture.				All digitally designed custom abutments or Pre-milled Blank abutments or Pre-milled Blank abutments a Terrats Medical
			Compatible Implant Systems
		Compatible Implant System	Implant Body Diameter, mm		Implant Platform Name
		Ankylos C/X	3.5, 4.5, 5.5		2.52

Table 7 - Substantial Equivalence - Indications for Use

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

	Astra Tech EV	3.0	3.0
		3.6	3.6
		4.2	4.2
		4.8	4.8
		5.4	5.4
	Astra Tech OsseoSpeed™	3.0	3.0
		3.5/4.0	3.5/4.0
		4.5/5.0	4.5/5.0
	BioHorizons	3.0, 3.4, 3.8	3.0
		3.8, 4.6	3.5
		4.6, 5.8	4.5
		5.8	5.7
	Biomet 3i Certain®	3.25	3.4
		4.0	4.1
		5.0	5.0
	Biomet 3i OSSEOTITE®	3.25	3.4
		3.75, 4.0	4.1
		5.0	5.0
	Camlog	3.8	3.8
		4.3	4.3
		5.0	5.0
	Dentium SuperLine	3.6, 4.0, 4.5, 5.0, 6.0, 7.0	3.3
	FRIADENT XIVE®	3.4	3.4
		3.8	3.8
		4.5	4.5
		5.5	5.5
	MegaGen AnyRidge	3.5, 4.0, 4.5, 5.0, 5.5	3.5
	Neodent Grand Morse	3.5, 3.75, 4.0, 4.3, 5.0, 6.0, 7.0	Grand Morse (GM)
	NobelActive®, NobelParallel Conical	3.0	3.0
		3.5	NP
		4.3, 5.0	RP
	NobelReplace® Trilobe	3.5	NP
		4.3	RP
Reference DevicesK100993Inclusive TitaniumAbutments forOsseoSpeed	The Inclusive Titanium Abutments for Astra OsseoSpeed Implants are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation. They are compatible with the Astral Tech OsseoSpeed 3.0, 3.5, 4.0,4.5, 5.0 implants.
K052648Modification 3iPatient-Specific	The 3i Patient-Specific Dental Abutments and Overdenture Bars are intended for use as an accessory to an endosseous dental implant to support a prosthetic device in a partially or edentulous patient. It is intended for use to support single and multiple tooth prostheses, in the mandible or maxilla. The prostheses can be screw or cement retained to the abutment.

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

and OverdentureBars
K092341Biomet 3i LowProfile Abutments	BIOMET 3i Dental Abutments are intended for use as accessories to endosseous dental implants to support a prosthetic device in a partially or completely edentulous patient. A dental abutment is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be screw retained or cement retained to the abutment.

Table 8 - Substantial Equivalence - Technological Characteristics

Comparison	Subject Device	Subject Device	PrimaryPredicate(K222288)	Reference Device(K100993)	Reference Device(K052648)	Reference Device(K092341)
	TiBase Abutment	Pre-milledAbutment Blank	DESS DentalSmart Solutions	Inclusive TitaniumAbutments forAstra OsseoSpeed	Modified 3i Patient-Specific DentalAbutments andOverdenture Bars	Biomet 3i LowProfile Abutments
	Zfx GmbH	Zfx GmbH	Terrats MedicalSL	PrismatikDentalcraft
Design
PlatformDiameter(mm)	2.9mm, 3.4mm,3.5mm, 4.1mm,4.5mm, 5.0mm,5.7mm	2.9mm, 3.4mm,3.5mm, 4.1mm,4.5mm, 5.0mm,5.7mm, 6.0mm	4.5 - 6.5mm	3.0-5.0mm	3.4 - 6 mm	3.4-5.0mm
GingivalHeight (mm)	0.25-5.75mm	0.25 - 6.0 mm	0.3 - 6.0 mm	Multiple stockabutments	0.25 mm (min)	1.0-5.0mm
Post Height(mm)	4.0. 4.5, 4.75, 5.7	Min = 4.0 mm	4.0, 4.2, 4.5, 4.7mm	Multiple stockabutments	4.5 mm (min)	6.2mm (max)
AbutmentAngle	Straight (0degrees),Up to 30 degrees	Straight (0degrees),Up to 30 degrees	Straight (0degrees),Up to 30 degrees	Straight (0degrees),Up to 30 degrees	Straight (0 degrees),Up to 30 degrees	Straight (0 degrees),Up to 30 degrees
Implant/AbutmentConnection	Internal;Engaging; Non-engaging	Internal ;Engaging; Non-engaging	Internal, ExternalEngaging; Non-engaging	Internal	External Hex,Internal	External Hex,Internal
RestorationType	Single unit &Multi-unit	Single unit &Multi-unit	Single unit &Multi-unit	Single unit &Multi-unit	Single unit & Multi-unit	Single unit & Multi-unit
ProsthesisAttachment	Screw or Cementretained	Screw or Cementretained	Screw or Cementretained	Cement retained	Screw or Cementretained	Screw or Cementretained
Material
Abutment	Ti-6Al-4V ELI	Ti-6Al-4V ELI	Ti-6Al-4V ELICo-Cr-Mo Alloy	Ti-6Al-4V ELI	Ti-6Al-4V ELI	Ti-6Al-4V ELI
RetainingScrew	Ti-6Al-4V ELIStainless steel 316Lwith gold-plating	Ti-6Al-4V ELIStainless steel 316Lwith gold-plating	Ti-6Al-4V ELIDLC coating	Ti-6Al-4V ELI	Titanium AlloyGold Alloy	Stainless steel 316Lwith gold-plating

Conclusion

The subject device has demonstrated substantial equivalence to the predicate device in that it has the same intended use, uses the same operating principle, incorporates the same basic design and materials, and uses the same sterilization method.

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.)