The Zimmer Zfx Abutment for Nobel Replace Implant System is designed for use as a terminal or intermediate abutment for cement retained prostheses. The abutment can be used with NobelReplace, Replace Select and NobelSpeedy abutinent our be access with a Narrow Platform (NP) Ø 3.5 mm, Regular Platform (RP) Ø 4.3 mm, Wide Platform (WP) Ø 5.0 mm or 6.0 Platform (6.0) Ø 6.0 mm.

Device Description

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. They frequently incorporate the modifications typically done at a dental laboratory or "chair-size" 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, the 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 Zimmer Zfx Abutment for NobelReplace Implant System is a dental implant abutment with a fixed competitor compatible interface. It is designed for use with NobelReplace endosseous dental implants to support single or multi tooth restorations. The abutment-implant interface is an internal tri-lobe. 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 (Ti6AI4V) and it is secured to the implant with a separate Titanium allov screw for retention.

The new abutment will be available with a choice of 3.5mm, 4.3mm, 5.0mm, and 6.0mm platform diameters. The maximum abutment anqulation will be 20°. The new abutment will interface with Nobel Replace implants with an internal tri-lobe connection.

AI/ML Overview

This document describes the Zimmer Zfx Abutment for NobelReplace Implant System, a dental implant abutment. The submission is a Traditional 510(k) Premarket Notification (K120873) seeking to demonstrate substantial equivalence to legally marketed predicate devices.

Acceptance Criteria and Device Performance:

The document implicitly defines acceptance criteria through the comparison of the new device to established predicate devices and the performance of non-clinical mechanical fatigue testing. The primary acceptance criterion appears to be demonstrating substantial equivalence to the predicate devices regarding material, general design features, and mechanical suitability.

The device performance is reported as meeting these criteria, as stated in the conclusion: "Based on our analysis, the device is substantially equivalent to the predicate."

Here's the table of acceptance criteria and reported device performance, derived from the comparison to predicate devices and testing described:

Feature/Criterion	Acceptance Criteria (Based on Predicate Devices)	Reported Device Performance
Material	Titanium or Titanium 6Al-4V (Matching Predicates 1, 2, 3)	Titanium 6Al-4V (Matches predicates)
Implant Interface	Internal Hex (Predicate 1) or Internal Tri-lobe (Predicates 2, 3)	Internal Tri-lobe (Matches Predicates 2 & 3)
Emergence	Contoured, curved (Matching Predicates 1, 2, 3)	Contoured, curved (Matches predicates)
Margin	Pre-machined (Matching Predicates 1, 2, 3)	Pre-machined (Matches predicates)
Platform Diameter	Ranges including 3.5mm, 4.3mm, 5.0mm, 6.0mm (Consistent with various predicates)	3.5mm, 4.3mm, 5.0mm, 6.0mm (Covers range of predicates)
Cuff Width	Range (e.g., 3.5mm-8.0mm, 3.5mm-16mm, 4.2mm for predicates)	3.5mm-12mm (Within range provided by predicates)
Cone and Overall Cone Height	Range (e.g., 3mm-12mm, 15mm overall, 6.5-7.5mm for predicates)	3.0-11.5 Cone, 3.5-12.0 Overall (Within range of predicates)
Maximum Angulation	Range (e.g., 30°, 25°, 15° for predicates)	20° (Within range of predicates)
Retaining Screw	Functionally equivalent to screws used with predicates	New device (Implies functional equivalence to predicate retaining screws)
Mechanical Compatibility	Compatible fit with NobelReplace implants with tri-lobe connection.	Reverse engineering, tolerance analysis, and rotational analysis demonstrated compatibility with NobelReplace tri-lobe implant interface.
Mechanical Fatigue	Demonstrate mechanical suitability for placement in all regions of the mouth, comparable to predicate devices.	Fatigue testing using Zimmer fabricated abutments assembled to OEM implants demonstrated substantial equivalence to NobelReplace predicate device fatigue data.
Sterilization (End-User)	Sterilizable to a minimum sterility assurance level of 10-6.	Sterilization procedures listed in IFU validated to provide a minimum sterility assurance level of 10-6.

Study Information:

Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: The document does not specify the exact sample size for the mechanical fatigue testing. It states that "all sizes" of the implant/abutment assembly were tested. The reference to "actual measurements taken off NobelReplace implants, abutments and retaining screws" suggests a physical sampling of these predicate devices for reverse engineering.
- Data Provenance: The testing was non-clinical. The information does not specify the country of origin for the components used in testing, but the company is US-based (Carlsbad, CA). The data is prospective in relation to the new device's design and verification.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable. The "ground truth" for the test set (e.g., dimensional specifications, mechanical performance) was established through engineering analysis, reverse engineering, and mechanical testing, not through expert consensus on medical images or clinical outcomes.
- Qualifications of Experts: The work was performed by Zimmer Dental Inc.'s engineering and regulatory teams, as implied by the non-clinical testing and internal documentation. Specific qualifications of individuals are not provided.
Adjudication method for the test set:
- Adjudication method: Not applicable in the traditional sense (e.g., 2+1, 3+1 for clinical assessments). The "adjudication" of the non-clinical test results would have been an internal review and comparison by Zimmer Dental's engineering and regulatory personnel against established standards (e.g., FDA guidance, internal specifications, predicate device data).
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. This device is a dental abutment, a manufactured physical component, not an AI or imaging diagnostic device. Therefore, MRMC studies and AI-related effectiveness are not relevant or discussed.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not applicable. As noted above, this is a physical medical device, not an algorithm or AI system.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Ground Truth Type:
  - For dimensional and interface compatibility: The "ground truth" was derived from physical measurements (reverse engineering) of the actual NobelReplace predicate implants and abutments. This provides a factual basis for interface design.
  - For mechanical fatigue: The "ground truth" involved mechanical test data generated from the predicate NobelReplace device, established according to FDA guidance (Class II Special Controls Guidance Document: Root-form Dental Implants and Endosseous Dental Implant Abutments). The new device's performance was then compared to this established predicate data.
The sample size for the training set:
- Training Set Sample Size: Not applicable. This is a physical device, not a machine learning model.
How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable. This is a physical device, not a machine learning model.

Summary

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

Zimmer Zfx Abutment for NobelReplace Implant System Zimmer Dental

1900 Aston Avenue

Carlsbad, CA 92008 760.929.4300 (ph) 760.431.7811 (fax)

510k No.: K120873

A5-1

NOV

్రెస

8 2012

Page No.:

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

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

Submitter's Information:
--------------------------

Name:	Zimmer Dental Inc.
Address:	1900 Aston Ave.
	Carlsbad, CA 92008
Phone:	760-929-4300
Contact:	Melissa Burbage

Date Prepared: November 1, 2012

Device Name:

Trade Name:	Zimmer Zfx Abutment for NobelReplace Implant System
Regulation Number: ·	872.3630
Classification Code:	NHA
	Device Classification Name: Endosseous Dental Implant Abutment

3. Predicate Device(s):

510(k) Number:

Regulation Number:

Classification Code:

Predicate Device No. 1 Trade Name:

Zimmer Patient-Specific Abutment, Internal Hex, Titanium K071439 872.3630 NHA Device Classification Name: Endosseous Dental Implant Abutment

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

NobelProcera Ti Abutment K091756 872.3630

Device Classification Name: Endosseous Dental Implant Abutment

Predicate Device No. 3
Trade Name:	Replace TiUnite Endosseous Implant
510(k) Number:	K023113
Regulation Number:	872.3640
Classification Code:	DZE
Device Classification Name:	Implant, Endosseous, Root-form

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

510(k) No.
Page No.	A5-2

4. Device Description:

The abutment is composed of Titanium alloy (Ti6AI4V) and it is secured to the implant with a separate Titanium allov screw for retention.

ട. Indications for Use:

The Zimmer Zfx Abutment for Nobel Replace Implant System is designed for use as a terminal or intermediate abutment for cement retained prostheses. The abutment can be used with NobelReplace, Replace Select and NobelSpeedy Replace implants with a Narrow Platform (NP) Ø 3.5 mm, Regular Platform (RP) Ø 4.3 mm, Wide Platform (WP) Ø 5.0 mm or 6.0 Platform (6.0) Ø 6.0 mm.

6. Device Comparison:

The new device is substantially equivalent to the predicate relative to material and general design features. The function in the endosseous implant system remains the same as the predicate devices. It is fabricated from Titanium alloy and utilizes the tri-lobe implant/abutment interface. which is similar in size and shape (for a given platform diameter) to the predicate device. The new device will be affixed to the implant by a retaining screw, the same manner as the predicate. Mechanical fatigue testing has demonstrated that all sizes of the implant/abutment assembly are mechanically suitable for placement in all regions of the mouth, including the posterior.

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

510(k) No.

Page No.

A5-3

7. Technological Characteristics

Feature	New DeviceZimmer ZfxAbutment forNobelReplaceImplant System	Predicate 1Zimmer TitaniumPSA	Predicate 2Nobel ProceraAbutment	Predicate 3NobelReplaceNP Abutment
Material	Titanium 6Al-4V	Titanium 6Al-4V	Titanium or Titanium6Al-4V	Titanium orTitanium 6Al-4V
ImplantInterface	Internal Tri-lobe	Internal Hex	Internal Tri-lobe	Internal Tri-lobe
Emergence	Contoured, curved	Contoured,curved	Contoured, curved	Contoured,curved
Margin	Pre-machined	Pre-machined	Pre-machined	Pre-machined
PlatformDiameter	3.5mm, 4.3mm,5.0mm, 6.0mm	3.5mm, 4.5mm,5.7mm	3.5mm, 4.3mm,5.0mm, 6.0mm	3.5mm
Cuff Width	3.5mm-12mm	3.5mm-8.0mm	3.5mm-16mm	4.2mm
Cone andOverall ConeHeight	3.0-11.5 Cone3.5-12.0 Overall	3mm-12mm	15mm overallabutment height	6.5-7.5mm
MaximumAngulation	20°	30°	25°	15°
RetainingScrew	New device	Cat. No. MHLAS	Cat No 36818 &29475	Cat No 36818

8. Non-Clinical Testing:

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 NobelReplace interface was reverse engineered based on actual measurements taken off NobelReplace implants, abutments and retaining screws in order to assure that the Zimmer Zfx Abutment for NobelReplace Implant System is compatible with NobelReplace Implants with tri-lobe connection. Dimensional specifications were developed for the Zimmer 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 fabricated parts and the OEM implant. To verify the compatibility of the Zimmer device to the OEM device, fatigue testing was completed using Zimmer 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 Implant Abutments. The results were compared to fatigue testing data of the NobelReplace predicate device and demonstrated that the proposed device is substantially equivalent to the predicate device. Based on the reverse engineering process, as well as verification of the final connection dimensions and tolerances, the

10(k) No

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

Zimmer Zfx Abutment for NobelReplace Implant System

510(k) No.
Page No.	A5-3

Zimmer Zfx Abutment for NobelReplace Implant System can be deemed compatible with the NobelReplace tri-lobe implant interface.

In addition, the Zimmer Zfx Abutment for Nobel Replace Implant System will be sold non-sterile and will be sterilized by the end user. The sterilization procedures listed in the instructions-for-use were validated to provide a minimum sterility assurance level of 10-6.

റ്റ. Clinical Testing

No clinical testing was performed. Non-clinical testing was used to support the decision of substantial equivalence.

10. Conclusion

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

し

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue

Document Control Center - WO66-G609 Silver Spring, MD 20993-002

Public Health Service

Letter Date: November 8, 2012

Zimmer Dental Incorporated Ms. Melissa Burbage Associate Director Regulatory Affairs 1900 Aston Avenue Carlsbad, California 92008

Re: K120873

Trade/Device Name: Zimmer Zfx Abutment for Nobel Replace Implant System Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: November 1, 2012 Received: November 2, 2012

Dear Ms. Burbage:

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.

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

Page 2 - Ms. Burbage

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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Kwame O.
Ulmer

Digitally signed by Kwame O. Ulmer
DN: c=US, o=U.S. Government, ou=HHS
ou=FDA, ou=People, cn=Kwame O.
Ulmer,
0.9.2342.19200300.100.1.1=1300183618
Date: 2012.11.08 15:54:26 -05'00'

for

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Respiratory, Infection Control and

Dental Devices

Office of Device Evaluation

. Center for Devices and

Radiological Health

Enclosure

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

K120873

Response to K120873 Page 1 of 1

Attachment 1

Z
immer

Indications for Use

510(k) Number (if known):

Device Name: Zimmer Zfx Abutment for Nobel Replace 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)

Snorase

(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital
Division of Anesthesiology, General Devices Division of Anesthesion gyl
Infection Control, Dental Devices 7

infection
510(k) Number: K120873

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.)