The Zimmer Zfx Titanium Abutment for Biomet 3i Certain Implant System is designed for use as a terminal or intermediate abutment for cement retained prostheses. The abutment can be used with Biomet 3i internal connection implants with a 3.4mm, 4.1mm, 5.0mm, or 6.0mm Platform.

Device Description

The Zimmer Zfx Titanium Abutment for the Biomet 3i Certain implant system is designed for use with Biomet 3i internal connection implants to support single or multi tooth restorations. The abutment/implant interface is an internal hexagonal connection.

The Zimmer Zfx Titanium Abutment for Biomet 3i Certain Implant System is a patient specific dental implant abutment with a competitor compatible interface. The purpose of a Patient-Specific abutment is to satisfy customer needs that are otherwise difficult to meet with off-the-shelf abutments. They can be manufactured in multiple sizes, shapes, and angles within the limits established in this submission. They frequently incorporate the modifications typically done at a dental laboratory or "chair-side" by a dentist. Traditional methodologies require the customer (dentist/laboratory technician) to begin with a "stock" abutment and use manual subtractive techniques to remove material from this original "stock" design. However, a Patient-Specific abutment will incorporate these same modifications desired by the customer (dentist/laboratory technician) at the time of fabrication at the manufacturing facility.

The engineering drawings list ranges in areas (attributes) of the abutment that may be modified depending upon patient-specific needs.

The abutment is composed of Titanium alloy (Ti6Al4V), and secured to the implant with a separate Titanium alloy screw for retention.

The new abutment will be offered in 3.4mm, 4.1mm, 5.0mm and 6.0mm implant platforms.

AI/ML Overview

The document describes a 510(k) premarket notification for the "Zimmer Zfx Titanium Abutment for Biomet 3i Certain Implant System." This submission focuses on establishing substantial equivalence to existing predicate devices through non-clinical testing. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative, pass/fail table for all features. Instead, it describes compatibility and mechanical fatigue testing. The performance is demonstrated by the results of these tests, which support the claim of substantial equivalence.

Acceptance Criteria (Implied)	Reported Device Performance
Dimensional compatibility with Biomet 3i internal connection implants and retaining screws	Reverse engineering confirmed compatibility. Dimensional specifications were developed for Zimmer Dental components based on reverse engineering results. A tolerance analysis and rotational analysis were conducted to illustrate the nature of fit.
Mechanical fatigue strength comparable to predicate device	Fatigue testing was completed using Zimmer Dental fabricated abutments assembled to OEM implants in accordance with FDA guidance. The results were compared to fatigue testing data of Predicate #3 device. (Specific quantitative results not provided in this summary, but the conclusion is that it met the required performance).
Sterility Assurance Level (SAL) per sterilization procedures	Sterilization procedures listed in the Instruction For Use were validated to provide a minimum sterility assurance level of 10⁻⁶.
MRI safety and compatibility	Evaluated for interactions with magnetic fields during MRI in accordance with FDA Guidance: Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment. (Conclusion implies no additional restrictions beyond those for the patient).

2. Sample size used for the test set and the data provenance

Test Set Sample Size: The document does not specify exact sample sizes for all tests. For "fatigue testing," it mentions "Zimmer Dental fabricated abutments assembled to OEM implants," but the number of samples is not provided.
Data Provenance: The testing was conducted by Zimmer Dental. The data is from non-clinical laboratory testing performed by the company to support their 510(k) submission. It is prospective in terms of the device being tested, but based on established methods. The country of origin for the data is not explicitly stated but can be inferred to be the USA, given the submission location and company address.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of experts: This information is not applicable. The "ground truth" for non-clinical testing is typically based on established engineering standards, material science principles, and FDA guidance documents, rather than expert consensus on a test set in the way it would be for a diagnostic AI device.
Qualifications of experts: Not specified.

4. Adjudication method for the test set

Adjudication method: Not applicable. As this is non-clinical testing of a physical device, there is no "adjudication" in the sense of reconciling expert opinions on observations. The performance is measured against predefined technical standards and predicate device data.

5. 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

MRMC study: No, a multi-reader, multi-case comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of images or data, often assisted by AI. The device in question is a dental implant abutment, meaning it's a physical medical device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Standalone performance: Not applicable. This device is a physical medical device (an abutment), not an algorithm or AI system. Therefore, standalone performance of an algorithm is not relevant.

7. The type of ground truth used

Ground Truth: The "ground truth" for this submission relies on:
- Established engineering specifications and measurements: For reverse engineering and dimensional compatibility.
- FDA guidance documents and recognized standards: Such as the "Class II Special Controls Guidance Document: Root-form Dental Implants and Endosseous Dental Implant Abutments" for mechanical fatigue testing, and "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment" for MRI safety.
- Predicate device data: For comparison of fatigue test results.

8. The sample size for the training set

Training Set Sample Size: Not applicable. This is a physical medical device. There is no "training set" in the context of machine learning. The device design and manufacturing processes are developed based on engineering principles and knowledge, not through machine learning training.

9. How the ground truth for the training set was established

Ground Truth for Training Set: Not applicable, as there is no training set for a physical medical device in this context.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of a human figure, represented by three overlapping profiles facing to the right.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 22, 2014

Zimmer Dental Incorporated Ms. Christina Boydston Quality Manager 1900 Aston Avenue Carlsbad, CA 92008

Re: K141544

Trade/Device Name: Zimmer Zfx Titanium Abutment for Biomet 3i Certain Implant System Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous dental implant abutment Regulatory Class: II Product Code: NHA Dated: September 22, 2014 Received: September 23, 2014

Dear Ms. Boydston:

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. 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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Page 2 - Ms. Boydston

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Susan Runno DDS, MA

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Image /page/2/Picture/2 description: The image shows the Zimmer Dental logo on the left and the words "Indications for Use" on the right. The Zimmer Dental logo consists of a stylized blue "Z" inside a circle, with the words "zimmer dental" below it. The words "Indications for Use" are written in a bold, sans-serif font.

K141544 510(k) Number (if known):

Device Name: Zimmer Zfx Titanium Abutment for Biomet 3i Certain Implant System

Indications For Use:

× Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Zimmer Dental 1900 Aston Avenue Carlsbad, CA 92008 760.929.4300 (ph) 760.431.7811 (fax)

Traditional 510(k) PRE-MARKET NOTIFICATION 510(k)

510(k) SUMMARY (21CFR807.92(a))

1. Submitter's Information:

Name:	Zimmer Dental Inc.
Address:	1900 Aston Ave.
	Carlsbad, CA 92008
Phone:	760-929-4300
Contact:	Christina Boydston
Date Prepared:	August 6, 2014

1. Device Name: Trade Name:
  Regulation Number: Classification Code: Device Classification Name: Zimmer Zfx Titanium Abutment for Biomet 3i Certain Implant System 872.3630 NHA Abutment, Implant, Dental, Endosseous
1. Predicate Device(s):
  Predicate Device No. 1 Trade Name:

510(k) Number: Regulation Number: Classification Code: Device Classification Name:

Predicate Device No. 2 Trade Name: 510(k) Number: Regulation Number: Classification Code: Device Classification Name:

Predicate Device No. 3 Trade Name: 510(k) Number: Regulation Number: Classification Code: Device Classification Name: Zimmer Zfx Abutment for NobelActive Implant System K134045 872.3630 NHA Abutment, Implant, Dental, Endosseous

Biomet 3i BellaTek Definitive Abutment K032263/K052648 872.3630 NHA Abutment, Implant, Dental, Endosseous

Biomet 3i Certain GingiHue Abutment K063341 872.3640 DZE Implant, Endosseous, Root-Form

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4. Device Description:

The engineering drawings list ranges in areas (attributes) of the abutment that may be modified depending upon patient-specific needs.

The abutment is composed of Titanium alloy (Ti6Al4V), and secured to the implant with a separate Titanium alloy screw for retention.

The new abutment will be offered in 3.4mm, 4.1mm, 5.0mm and 6.0mm implant platforms.

న్. Indications for Use:

6. Device Comparison:

The new abutment device is substantially equivalent to the predicate relative to material, manufacturing process and general design features. It is fabricated from Titanium alloy and utilizes an internal hexagonal connection, which is identical in size and shape (for a given platform diameter) to the predicate device. The new abutment and base device will be affixed to the implant by a retaining screw, the same manner as the predicate.

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Technological Characteristics 6.

Feature	New Device	Predicate #1	Predicate #2	Predicate #3
	Zimmer Zfx TitaniumAbutment for Biomet 3iCertain Implant System	Zimmer Zfx Abutmentfor NobelActiveImplant System	Biomet 3i CertainBellaTek DefinitiveAbutment	Biomet 3i Certain GingiHueAbutment
Material	Titanium 6Al-4V	Titanium 6Al-4V	Titanium Alloy	Titanium Alloy
ImplantInterface	Internal Hex	Internal Conical,Internal Hex	Internal Hex	Internal Hex
Emergence	Contoured, curved	Contoured, curved	Contoured, curved	Contoured, curved
Margin	Pre-machined	Pre-machined	Pre-machined	Pre-machined
PlatformDiameter	3.4mm, 4.1mm,5.0mm, and 6.0mm	3.5mm, 3.9mm	3.4mm, 4.1mm,5.0mm, and 6.0mm	3.4mm, 4.1mm, 5.0mm, and6.0mm
Cuff Width/Diameter	3.4-8.0 (3.4 Platform)4.1-9.0 (4.1Platform )5.0-10.0 (5.0 Platform)6.0-12.0 (6.0 Platform)	3.0mm-9mm (NP)3.4mm-9mm (RP)	3.8mm-16.0mm	3.8mm (3.4 platform)5.0mm, 6.0mm, and 7.5mm(4.1, 5.0 platforms)6.0mm and 7.5mm (6.0platform)
MinimumHeight	3.0mm MIN Cone3.0mm-12.0mm Overall	3.0mm MIN Cone3.0mm-12.0mmOverall	4.75mm-15mm	7.0mm Cone9.0mm and 11.0mm Overall
Cone Angle	0-30°	0-25°	0-30°	30°
RetainingScrew	New device	ZFX0900027 andZFX09000628	Cat No. IUNIHG andIUNIHT	Cat No. IUNIHG andIUNIHT

Non-Clinical Testing: 8.

Non-clinical test data was used to support the decision of substantial equivalence. This consisted of reverse engineering, compatibility analysis and mechanical fatigue testing. The Biomet 3i internal connection interface was reverse engineered based on actual measurements taken from Biomet 31 internal connection implants, abutments and retaining screws in order to assure that the Zimmer Zfx Titanium Abutment for Biomet 3i Certain Implant System is compatible with Biomet 3i internal connection Implant Systems. Dimensional specifications were developed for the Zimmer Dental fabricated components based on the reverse engineering results. A tolerance analysis as well as a rotational analysis was conducted to illustrate the nature of fit between the Zimmer Dental fabricated parts and the OEM implant. To verify the compatibility of the Zimmer Dental device to the OEM device, fatigue testing was completed using Zimmer Dental fabricated abutments assembled to OEM implants in accordance with the FDA guidance Class II Special Controls Guidance Document: Root-form Dental Implants and Endosseous Dental

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Implant Abutments. The results were compared to fatigue testing data of the predicate #3 device. Based on the reverse engineering process, as well as verification of the final connection dimensions and tolerances, the Zimmer Zfx Titanium Abutment for Biomet 3i Certain Implant System can be deemed compatible with the Biomet 3i internal connection implant interface.

In addition, the Zimmer Zfx Titanium Abutment for the Biomet 3i Certain Implant System will be sold non-sterile and will be sterilized by the end user. The sterilization procedures listed in the Instruction For Use were validated to provide a minimum sterility assurance level of 10°.

Additionally, Zimmer Dental implant systems were evaluated for interactions with magnetic fields during Magnetic Resonance Imaging (MRI) in accordance with the FDA Guidance: Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment. This was done to determine that the presence of the abutment poses no additional restrictions on MRI beyond those that would otherwise occur for the patient.

9. Clinical Testing

No clinical testing was performed. Non-clinical testing was used to support the decision of safety and effectiveness.

1. Conclusion
  Based on our analysis, the device is substantially equivalent to the predicate.

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.)