The Zimmer Cast-to Gold Abutments for the 3.1mmD Dental Implant System, Engaging, is intended for use in the creation of a customized abutment for a cement-retained crown or bridge, or a customized screw-retained restoration.

The Zimmer Cast-to Gold Abutments for the 3.1mmD Dental Implant System, Non-Engaging, is intended for use in the creation of customized multiple-unit restorations on implants (e.g., bars and bridges), when anti-rotation of the abutment is not necessary.

Device Description

The purpose of an abutment with Cast-to capabilities is to satisfy customer needs of attaching cast framework prostheses to an abutment. The nonengaging Zimmer Cast-to Gold Abutments for the 3.1mmD Dental Implant System can be used as base to cast frameworks for multiple unit crown and bridge and bar over denture restorations by a dental laboratory using a precious metal alloy. The engaging Zimmer Cast-to Gold Abutments for the 3.1mmD Dental Implant System can be used as base to cast a single abutment for a cement-retained crown or bridge and frameworks for multiple unit crown and bridge and bar over denture restorations by a dental laboratory using a precious metal alloy. The Zimmer Cast-to Gold Abutments for the 3.1mmD Dental Implant System is designed for use with Zimmer 3.1mmD Dental Implant System to support cast framework prostheses. The engaging abutment/implant interface is an internal conical connection with a hex. The non-engaging abutment/implant interface is a connection that sits on top of the implant but does also has cylindrical features that sit passively within the implant.

The abutment is composed of Gold Alloy 6019 and secured to the implant with a separate Titanium alloy screw for retention.

AI/ML Overview

The provided text is a 510(k) Premarket Notification for a medical device (Zimmer Cast-to Gold Abutments for the 3.1mmD Dental Implant System). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing a detailed acceptance criteria table and a study proving the device meets those criteria in the way a clinical trial or performance study for a novel device would.

Therefore, much of the requested information regarding detailed acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert consensus, and comparative effectiveness studies is not present in this document, as it is not typically required or included in a 510(k) submission for this type of device.

However, I can extract the information that is available and indicate where the requested information is not provided.

Acceptance Criteria and Device Performance

The document does not present a formal table of acceptance criteria with specific quantitative targets and corresponding device performance data for the Zimmer Cast-to Gold Abutments in isolation. Instead, it relies on demonstrating substantial equivalence to predicate devices through technical characteristics, material composition, and non-clinical testing.

The acceptance criteria are implicitly met by showing that the device performs at least as well as the predicate device in relevant non-clinical tests, and that differences do not raise new questions of safety or effectiveness.

Acceptance Criteria (Implicit)	Reported Device Performance (Summary)
Material Biocompatibility	Same biocompatible Gold Alloy 6019 as predicate (K011028), previously tested and cleared.
Mechanical Performance	Sustained fatigue and compression testing in accordance with ISO 14801:2007 (dynamic fatigue) and FDA guidance for Class II root-form dental implants. Testing indicates "substantially equivalent to the predicate device in terms of static and fatigue testing."
Sterilization	User sterilization procedures (listed in IFU) validated to provide a minimum sterility assurance level (SAL) of 10⁻⁶.
MRI Compatibility	Evaluated for interactions with magnetic fields during MRI per FDA guidance and ASTM F 2182 (heating). Results support MR conditional labeling.
General Design & Manufacturing Process	"Equivalent to predicate devices in general abutment design, manufacturing process, material, indications, mechanical performances, and risk."

Study Details

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: Not specified. The non-clinical testing involved fatigue and compression tests on physical samples of the device. The exact number of samples used for these tests is not provided in this summary.
- Data Provenance: Not specified, but likely from in-house or contracted laboratory testing based on the standards cited. The document does not mention country of origin or whether it was retrospective or prospective, as these terms are typically applied to clinical studies.
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 specified. Ground truth as typically understood in AI/clinical studies (e.g., expert consensus on diagnoses) is not relevant for this type of mechanical engineering performance testing. The "ground truth" for the mechanical tests would be the established engineering standards and physical measurements.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not specified. Adjudication methods are typically used in clinical imaging studies to resolve discrepancies in expert interpretations. This document describes mechanical testing.
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
- No. This is a mechanical device, not an AI-powered diagnostic tool. Therefore, MRMC studies and "human readers improving with AI assistance" are not relevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is a mechanical device. Standalone algorithm performance is not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the non-clinical tests would be the physical and mechanical properties measured against established engineering standards (ISO 14801:2007) and FDA guidance limits. For biocompatibility, the ground truth was based on previous testing of the predicate device's material (Gold Alloy 6019) in compliance with ISO 10993-1.
The sample size for the training set
- Not applicable/Not specified. There is no mention of a "training set" as this is not an AI/machine learning device.
How the ground truth for the training set was established
- Not applicable. There is no training set for this type of mechanical device submission.

Summary

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

May 1, 2015

Zimmer Dental Inc. Ms. Christina Boydston Regulatory Affairs Manager 1900 Aston Ave. Carlsbad, California 92008

Re: K143528

Trade/Device Name: Zimmer Cast-to Gold Abutments for the 3.1mmD Dental Implant System Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: April 2, 2015 Received: April 3, 2015

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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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 devicerelated 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 Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

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 Industry and Consumer Education 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,

Tina
Kiang -S

for 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

Enclosure

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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 is a blue Z inside of a circle, with the words "zimmer dental" below it. The words "Indications for Use" are in black and are in a larger font than the words "zimmer dental."

510(k) Number (if known): K143528

Device Name: Zimmer Cast-to Gold Abutments for the 3.1mmD Dental 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 arlsbad, CA 92008 60.929.4300 (ph) 60.431.7811 (fax)

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

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

K143528

1. Submitter's Information:

Name:	Zimmer Dental Inc.
Address:	1900 Aston Ave.
	Carlsbad, CA 92008
Phone:	760-929-4300
Contact:	Christina Boydston
Date Prepared:	April 29, 2015

1. Device Name: Trade Name:
  Regulation Number: Classification Code: Classification: Device Classification Name: Zimmer Cast-to Gold Abutments for the 3.1mmD Dental Implant System 872.3630 NHA II Abutment, Implant, Dental, Endosseous

3. Predicate Device(s):

Predicate Device No. 1
Trade Name:	"Cast-To" Gold Abutments, Engaging
510(k) Number:	K011028
Regulation Number:	872.3630
Classification Code:	NHA
Device Classification Name:	Abutment, Implant, Dental, Endosseous

Predicate Device No. 2 Trade Name: "Cast-To" Gold Abutments, Non-Engaging 510(k) Number: K011028 872.3630 Regulation Number: Classification Code: NHA Device Classification Name: Abutment, Implant, Dental, Endosseous

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4. Device Description:

The abutment is composed of Gold Alloy 6019 and secured to the implant with a separate Titanium alloy screw for retention.

న్. Indications for Use:

Zimmer Cast-to Gold Abutments for the 3.1mmD Dental Implant System, Engaging

Zimmer Cast-to Gold Abutments for the 3.1mmD Dental Implant System, Non-Engaging

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6. Device Comparison:

Differences in technological characteristics between the subject and predicate device did not raise different questions of safety and effectiveness, and that mechanical testing was used to support a conclusion of substantial equivalence (please see non-clinical testing section for details). The subject abutment is substantially equivalent to the predicate relative to material, general design features as well as design and manufacturing process. It is fabricated from Gold alloy. The differences are the implant/abutment interface and platform sizes. The subject abutment and base device will be affixed to the implant by a retaining screw, the same manner as the predicate.

Feature	Subject Device 1Zimmer Cast-to GoldAbutment for the3.1mmD Dental ImplantSystem, Engaging	Predicate 1"Cast-To" GoldAbutments, EngagingK011028	Subject Device 2Zimmer Cast-to GoldAbutment for the3.1mmD Dental ImplantSystem, Non-Engaging	Predicate 2"Cast-To" Gold Abutments,Non-EngagingK011028
Material	Gold Alloy 6019	Gold Alloy 6019	Gold Alloy 6019	Gold Alloy 6019
ImplantInterface	Internal HexConical Connection	Internal Hex	Non-engaging conicalconnection	Non-hex connection that sitson the top of the implant
Platforms	2.9mm	3.5mm, 4.5mm,5.7mm	2.9mm	3.5mm, 4.5mm
MaximumAbutmentAngulation	30°	30°	30°	30°
Method ofAttachment	Retaining screw	Retaining Screw	Retaining screw	Retaining Screw
RetainingScrew	Cat. No. CUASCat. No. CASLC	Cat. No. MHLASCat. No. MTWSD	Cat. No. CUAS	Cat. No. MHLAS

7. Technological Characteristics

8. Non-Clinical Testing:

Non-clinical test data was used to support the decision of substantial equivalence. Non-clinical testing consisted of performance of fatigue and compression testing in accordance with the FDA guidance Class II Special Controls Guidance Document: Root-form Dental Implants and Endosseous Dental Implant Abutments and ISO 14801:2007 Dentistry - Implants -Dynamic fatigue test for endosseous dental implants. The testing indicates that the subject device is substantially equivalent to the predicate device in terms of static and fatigue testing.

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In addition, the Zimmer Cast-to Gold Abutments for the 3.1mmD Dental 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°.

The subject abutment will be manufactured using biocompatible material. The subject abutment will be manufactured using the same material as the predicate which were cleared in K011028; therefore, no additional biocompatibility testing was performed on the subject device. The Biocompatibility of the raw material and manufacturing process testing of Gold Alloy 6019 was previously conducted, documented and cleared in the predicate submission (K011028). Biocompatibility testing was completed in compliance to ISO 10993-1 Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process.

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 and ASTM F 2182: Standard Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants during Magnetic Resonance Imaging. The results of these tests support the MR conditional labeling of this device.

9. Clinical Testing

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

10. Conclusion

The subject device, Zimmer Cast-to Gold Abutments for the 3.1mmD Dental Implant System are gold alloy, abutments with an engaging or non-engaging interface and are designed to provide support for a cast framework.

The Zimmer Cast-to Gold Abutments for the 3.1mmD Dental Implant System is equivalent to predicate devices in general abutment design, manufacturing process, material, indications, mechanical performances, and risk. The subject devices are Magnetic Resonance Imaging (MRI) compatible conditionally with respect to patient safety.

The Zimmer Cast-to Gold Abutments for the 3.1mmD Dental Implant System will be manufactured from the same biocompatible material (Gold Alloy 6019) as predicate devices, will be manufactured and inspected according to approved engineering drawings, and Zimmer Dental procedures, and will be packaged in a similar manner as the predicate devices. The subject devices will be sold non

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sterile and will be labeled as "non-sterile", and is intended to be sterilized by the end user. The sterilization procedures were validated to provide a minimum sterility assurance level of 10-6.

Based on the above analysis and the 510(k) submission for Zimmer Cast-to Gold Abutments for the 3.1mmD Dental Implant System, the subject 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.)