The Plastic Temporary Abutment is intended to be used to fabricate and support provisional restorations that aid in creating an esthetic emergence through the gingiva during the healing period and prior to final restoration. The Plastic Temporary Abutment can be used for cement-retained or screw-retained provisional restorations. The abutments can be used for single-unit and multi-unit restorations. Use of the Plastic Temporary Abutment is not to exceed onehundred and eighty (180) days.

Device Description

The Plastic Temporary Abutments are endosseous dental implant abutments that are designed for single use as a temporary prosthesis during the healing process while the permanent prosthesis is fabricated. The PEEK CLASSIX material, when utilized as a Temporary Abutment, can be placed in use for up to 180 days. They are available in straight and angled versions, with interfaces to match the three diameters of Tapered Screw-Vent Implants, and 1mm or 4mm cuff height options.

AI/ML Overview

This submission is a 510(k) Pre-Market Notification for a Class II medical device, the Zimmer Dental Plastic Temporary Abutment, with product code NHA and regulation number 872.3630. This is a substantial equivalence determination to previously cleared predicate devices. Therefore, the information provided focuses on demonstrating equivalence rather than establishing novel performance criteria through extensive study.

Here's an analysis of the provided text in relation to your questions, noting that many aspects of your request (e.g., specific acceptance criteria for performance metrics, detailed study designs, and ground truth establishment) are generally not part of a 510(k) summary for devices demonstrating substantial equivalence to predicates, especially for mechanical components like dental abutments.

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, there are no explicit quantitative acceptance criteria or detailed performance metrics reported from a study. The submission focuses on demonstrating "substantial equivalence" to predicate devices based on design, materials, and intended use.

However, the "performance" demonstrated is that the device is fit for its intended use, which is indirectly verified by its similarity to already marketed devices.

Acceptance Criteria (Implied)	Reported Device Performance
Material Equivalence: Material composition should be similar to predicate devices.	The Plastic Temporary Abutment utilizes PEEK CLASSIX material, similar to the body material of the PreFormance Post and considered similar to the Friadent® EsthetiCap.
Design Equivalence (Functionality): The device's design should enable its intended function.	The Plastic Temporary Abutment is "substantially equivalent to the original Hex-Lock® Temporary Abutment by design." It is designed for single use as a temporary prosthesis during healing, supporting provisional restorations. Available in straight and angled versions, with interfaces to match Tapered Screw-Vent Implants (three diameters) and 1mm or 4mm cuff height options.
Intended Use Equivalence: Indications for use should align with predicate devices.	"The Plastic Temporary Abutment is intended to be used to fabricate and support provisional restorations that aid in creating an esthetic emergence through the gingiva during the healing period and prior to final restoration. The Plastic Temporary Abutment can be used for cement-retained or screw-retained provisional restoration. The abutments can be used for single-unit and multi-unit restorations." This is stated to be similar to predicate devices.
Duration of Use Equivalence: Maximum recommended use duration should be comparable to predicate devices.	"The PEEK CLASSIX material, when utilized as a Temporary Abutment, can be placed in use for up to 180 days." This duration is explicitly stated as equivalent to the PreFormance Post.
Safety and Effectiveness (Implied by Substantial Equivalence): The device should be as safe and effective as predicate devices for its intended use.	The FDA’s 510(k) clearance implies that the device is considered substantially equivalent to legally marketed predicate devices, and therefore, as safe and effective.

2. Sample Size Used for the Test Set and Data Provenance

The document describes a regulatory submission (510(k)) to demonstrate substantial equivalence, not an independent clinical or performance study with a "test set" in the typical sense of algorithm validation.

Sample Size for Test Set: Not applicable in the context of this submission. The submission relies on comparisons to predicate devices and their established safety and effectiveness.
Data Provenance: Not applicable. Material and design specifications are internal to the manufacturer, and predicate device information is publicly available regulatory data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This is not an AI/algorithm-based device requiring expert ground truth for performance evaluation of a test set. The "ground truth" for a 510(k) mechanical device is typically established through engineering tests (e.g., fatigue, torque, retention, biocompatibility, sometimes specified in guidance documents for dental implants/abutments) and comparison to predicate devices, rather than expert consensus on a test set of cases. These engineering tests are summarized for regulatory clearance, but the detailed results are not provided in this 510(k) summary.

4. Adjudication Method for the Test Set

Not applicable, as there is no "test set" or human-interpretable data requiring adjudication described in this submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is typically for image-based diagnostic or prognostic AI systems to evaluate the impact on human reader performance, which doesn't apply to a mechanical dental abutment.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, this is not an algorithm-based device. It's a physical medical device (dental abutment).

7. The Type of Ground Truth Used

The "ground truth" in this context is the known safety and effectiveness of the existing predicate devices and the established engineering principles and material specifications for dental abutments.

For materials: established biocompatibility and mechanical properties of PEEK CLASSIX.
For design: compatibility with existing implant designs, and mechanical integrity proven through engineering analysis or testing (though not detailed here).
For intended use: alignment with the indications for use of the predicate devices.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI model requiring a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for an AI model.

Summary of what is known from the document regarding "proof" of meeting criteria:

The "study" in this context is the comprehensive 510(k) submission process itself, where Zimmer Dental provided evidence to the FDA demonstrating that their Plastic Temporary Abutment is "substantially equivalent" to legally marketed predicate devices. This typically involves:

Comparison of Indications for Use: The submitted device has the same intended use as the predicate devices.
Comparison of Technological Characteristics: Details like material (PEEK CLASSIX), design (straight/angled, cuff heights, implant interfaces), and duration of use (180 days) are shown to be equivalent or introduce no new safety/effectiveness concerns compared to the predicates.
Performance Data (often via engineering tests): While not detailed in this public summary, a 510(k) submission for such a device would typically include non-clinical performance data (e.g., mechanical tests like fatigue, torque, retention; biocompatibility data) to support the substantial equivalence claim. This data would confirm that the device performs as expected for its mechanical function and material properties, falling within acceptable ranges established for predicate devices.

The FDA's clearance (NOV - 3 2009 letter) signifies their agreement that Zimmer Dental has provided sufficient information to demonstrate substantial equivalence, thus inferring that the new device meets the same safety and effectiveness standards as its predicates.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Zimmer Dental. The logo consists of a circle with a stylized "Z" inside, above the word "zimmer" in a serif font. Below "zimmer" is the word "dental" in a sans-serif font.

Zimmer Dental
---------------

K092377 510k No.:

A5-1 Page No.:

900 Aston Avenue Carlsbad, CA 92008 760.929.4300 (ph) 760.431.7811 (fax)

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

NOV - 3 2009

510(k) SUMMARY (21CFR 807.92(a))

1. Submitter's Information:

Name:	Zimmer Dental Inc.
Address:	1900 Aston Ave.Carlsbad, CA 92008
Phone:	760-929-4300
Contact:	William Fisher
Date Prepared:	November 3, 2009

1. Plastic Temporary Abutment Device Name: Device Classification Name: Endosseous Dental Implant Abutment Device Regulation Number : 872.3630 Product Code : NHA, Dental
Hex-Lock® Temporary Abutment 3. Predicate Device(s): Friadent® EsthetiCap PreFormance Post

Device Description: 4.

Indications for Use: 5.

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

abutments can be used for single-unit and multi-unit restorations. Use of the Plastic Temporary Abutment is not to exceed one-hundred and eighty (180) days.

6. Device Comparison:

The Plastic Temporary Abutment is substantially equivalent to the original Hex-Lock® Temporary Abutment by design. They are substantially equivalent to the Friadent® EsthetiCap in that the materials and intended use are similar for both products. The Plastic Temporary Abutment is substantially equivalent to the PreFormance Post in that the body of the products are the same material as well as the intended use and period of use are equivalent.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with outstretched arms, representing care and protection. The figure is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in capital letters.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

Mr. William Fisher Regulatory Affairs Associate Zimmer Dental, Incorporated 1900 Aston Avenue Carlsbad, California 92008-7308

NOV - 3 2009

Re: K092377

Trade/Device Name: Plastic Temporary Abutment Regulation Number: 21CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: August 3, 2009 Received: August 5, 2009

Dear Mr. Fisher:

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.

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- Mr. Fisher

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,

Susan Rumsey

Susan Runner, D.D.S., M.A. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) No. Zimmer Dental Plastic Temporary Abutment

No. K092377

A4 Page 1 of 1

Indications for Use

510(k) Number (if known):

Plastic Temporary Abutment Device Name:

Indications For Use:

The Plastic Temporary Abutment is intended to be used to fabricate and support provisional restorations that aid in creating an esthetic emergence through the gingiva during the healing period and prior to final restoration. The Plastic Temporary Abutment can be used for cementretained or screw-retained provisional restorations. The abutments can be used for single-unit and multi-unit restorations. Use of the Plastic Temporary Abutment is not to exceed onehundred and eighty (180) days.

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)

Keri Mulry for HSR

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

510(k) Number: K092377

Page 1 of 1

Page: Section A4-1

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.)