The Zimmer Contour Provisional Coping is for use with a Hex-Lock Contour Abutment or a Zimmer One-Piece Implant to prevent irritation of soft tissue due to rubbing against the restorative area of the abutment or implant, to prevent material from lodging in any undercuts or openings, and for fabricating a cement-retained provisional restoration. Use of the provisional coping is not to exceed 180 days.

The Short Provisional Coping is for use with a Short Hex-Lock Abutment to prevent irritation of soft tissue due to rubbing against the restorative area of the abutment or implant, to prevent material from lodging in any undercuts or openings, and for fabricating a cement-retained provisional restoration. Use of the provisional coping is not to exceed 180 days.

Device Description

The Contour Provisional Coping is a smooth plastic cap that fits passively over the cone of a Hex-Lock Contour Abutment or a Zimmer One-Piece Implant and mates with the margin of the abutment or implant abutment section. Each passive fit cap is affixed to the abutment/implant cone with appropriate dental adhesive material selected by the clinician.

The Short Provisional Coping is a tan, textured, plastic cap that fits passively over the cone of a Hex-Lock® Short Abutment and mates with the margin of the abutment.

AI/ML Overview

Here's an analysis of the provided text regarding the Zimmer Dental device, broken down into the requested categories:

1. A table of acceptance criteria and the reported device performance

Criteria	Acceptance	Reported Device Performance
Intended Use	To prevent irritation of soft tissue, prevent material lodging, and for fabricating a cement-retained provisional restoration (use not to exceed 180 days).	The device's indications for use are identical to the predicate devices.
Material Equivalence	PEEK material to demonstrate improvement in functional performance over predicate materials (Ultem and PMMA).	The new device uses PEEK, which is stated to "demonstrates an improvement in functional performance compared to Ultem and PMMA."
Design Equivalence	Maintain similar fit and design features to predicate devices.	"Modified devices are equivalent in intended use, design, and materials." Specific design features (e.g., "Mates uniquely with shape of Contour abutment," "Has indexing / anti rotation feature") are maintained as per the comparison table.
Safety and Efficacy (Overall)	As safe and effective for its intended use and performs as well or better than the predicate device(s).	"Based on our analysis, the device is substantially equivalent to the predicates and it is considered that the new device is as safe and effective for its intended use and performs as well or better than the predicate device(s)."
New Risks	No new safety or efficacy concerns and no new risks identified through modifications.	"modifications... do not bring up new concerns regarding safety and efficacy and no new risks have been identified."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not applicable. No "test set" in the context of clinical or performance data was used for a traditional AI or diagnostic device evaluation. This submission relies on non-clinical testing and comparison to predicate devices, not clinical data or a test set of patient cases.
Data Provenance: Not applicable. No clinical data or patient data was used.

3. 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. No ground truth establishment by experts for a test set was performed. The evaluation is based on material properties and design comparison.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No test set requiring adjudication was used.

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

No MRMC comparative effectiveness study was done. This is a submission for a physical dental device, not an AI diagnostic tool.

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

Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. The "ground truth" in this context is the performance and safety established by the predicate devices and the non-clinical testing demonstrating material properties.

8. The sample size for the training set

Not applicable. No training set was used. This is not an AI/ML device.

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

Not applicable. No training set or associated ground truth establishment was performed.

Summary of the Study Proving Device Meets Acceptance Criteria:

The Zimmer Dental submission (K113092) for the Zimmer® Contour Provisional Coping and Zimmer® Short Provisional Coping does not involve a study in the traditional sense of clinical data collection, AI algorithm evaluation, or human reader performance.

Instead, the "study" demonstrating the device meets acceptance criteria is a non-clinical equivalence study based on design, material, and intended use comparison to legally marketed predicate devices.

Non-Clinical Testing: "Non-clinical test data was not used to support the decision of safety and effectiveness. Clinical literature and material mechanical prosperities indicated that the device is strong enough to withstand the anticipated forces and demonstrated improvements over the predicate devices."
Equivalence Argument: The core of the submission is the argument of "substantial equivalence" to five predicate devices. This argument is built upon:
- Identical Indications for Use: The new devices share the exact same intended uses as their predicates (preventing soft tissue irritation, material lodging, and fabricating cement-retained provisional restorations for up to 180 days).
- Material Improvement: The new devices utilize PEEK (polyether ether ketone), which is stated to "demonstrate an improvement in functional performance compared to Ultem and PMMA" used in some predicate devices. This material change is presented as a benefit without introducing new risks.
- Maintained Design Characteristics: The comparison tables explicitly show that the fit (e.g., "Mates uniquely with shape of Contour abutment") and design features (e.g., "Has indexing / anti rotation feature") are maintained across the new and predicate devices.
- Manufacturing Process: The modified devices are manufactured using the "same process."
Conclusion: The manufacturer concluded that "the new device is as safe and effective for its intended use and performs as well or better than the predicate device(s)" based on this non-clinical comparison and the improved material. The FDA concurred with this assessment, granting 510(k) clearance by finding the device "substantially equivalent."

Summary

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Zimmer Dental

510k No.: K1130

1900 Aston Avenue Carlsbad, CA 92008 760.431.7811 (fax)

JAN 2 3 2012

A.5

Image /page/0/Picture/5 description: The image shows the logo for Zimmer Dental. The logo features a stylized letter "Z" inside of a circle. Below the circle, the word "zimmer" is written in a serif font, with a line underneath it, and the word "dental" is written in a sans-serif font below the line.

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

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

1. Submitter's Information:

Zimmer Dental Inc. Name:

Address: 1900 Aston Ave. Carlsbad, CA 92008

760-929-4300 Phone:

Contact: Jeremy Markovich

Date Prepared: October 17, 2011

1. New Device(s):
  New Device No. 1 Trade Name: Zimmer® Contour Provisional Coping Regulation Number: 872.3630 Classification Code: NHA Device Classification Name: Endosseous Dental Implant Abutment

New Device No. 2 Zimmer® Short Provisional Coping Trade Name: Regulation Number: 872.3630 NHA Classification Code: Device Classification Name: Endosseous Dental Implant Abutment

క. Predicate Device(s):
Predicate Device No. 1 Zimmer® Contour Provisional Coping Trade Name: K061043 510(k) Number: Regulation Number: 872.3630 Classification Code: NHA Device Classification Name: Endosseous Dental Implant Abutment

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Zimmer Dental	510k No.:
1900 Aston Avenue	Page No.:	A.5
Carlsbad, CA 92008
760.929.4300 (ph)
760.431.7811 (fax)

Predicate Device No. 2

Trade Name:	Zimmer® Short Provisional Coping
510(k) Number:	K090723
Regulation Number:	872.3630
Classification Code:	NHA
Device Classification Name:	Endosseous Dental Implant Abutment

Predicate Device No. 3

Trade Name:	Zimmer® Plastic Temporary Abutment
510(k) Number:	K092377
Regulation Number:	872.3630
Classification Code:	NHA
Device Classification Name:	Endosseous Dental Implant Abutment

Predicate Device No. 4

Trade Name:	Zimmer® Contour Healing Cap
510(k) Number:	K061043
Regulation Number:	872.3630
Classification Code:	NHA
Device Classification Name:	Endosseous Dental Implant Abutment

Predicate Device No. 5

Trade Name:	Zimmer® Short Healing Cap
510(k) Number:	K090723
Regulation Number:	872.3630
Classification Code:	NHA
Device Classification Name:	Endosseous Dental Implant Abutment

Device Description:

Implant and mates with the margin of the abutment or implant abutment section. Each passive fit cap is affixed to the abutment/implant cone with appropriate dental adhesive material selected by the clinician.

The Short Provisional Coping is a tan, textured, plastic cap that fits passively over the cone of a Hex-Lock® Short Abutment and mates with the margin of the abutment.

Indication for Use: 5.

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510k No.:
Page No.:	A.5

1900 Aston Avenue Carisbad, CA 92008 760.929.4300 (ph) 760.431.7811 (fax)

implant, to prevent material from lodging in any undercuts or openings, and for fabricating a cement-retained provisional restoration. Use of the provisional coping is not to exceed 180 days.

6. · Device Comparison:

Zimmer Dental Inc. believes the Zimmer® Contour Provisional Coping and Zimmer® Short Provisional Coping to be substantially equivalent to their respective predicates as listed below. The modified devices are not subject to geometry modification and will be manufactured using the same process. The modified devices are equivalent in intended use, design. and materials. PEEK (polyether ether ketone) material demonstrates an improvement in functional performance compared to Ultem and PMMA. The modifications affect product labeling; however, these changes do not bring up new concerns regarding safety and efficacy and no new risks have been identified.

Feature:	New Device 1:	Predicate No. 1:	Predicate No. 2:	Predicate No. 3:
	Contour ProvisionalCoping	Contour ProvisionalCoping	Zimmer PlasticTemporaryAbutment	Zimmer ContourHealing Cap
Material	PEEK (polyetherether ketone)	Ultem 1010-1101(polyetherimide)	PEEK (polyetherether ketone)	PMMA AcrylicCP-1000-IG
Fit	Mates uniquely withshape of Contourabutment.	Mates uniquely withshape of Contourabutment.	Hexagonconnection	Mates uniquelywith shape ofContourabutment.
DesignFeature	Has indexing / antirotation feature	Has indexing / antirotation feature	Straight or angled,collar heights in 1or 4mm. Groovesfor retention,defined margin	Has indexing /anti rotationfeature
Feature:	New Device 2:	Predicate No. 1:	Predicate No. 2:	Predicate No. 3:
	Short ProvisionalCoping	Short ProvisionalCoping	Zimmer PlasticTemporaryAbutment	Short Healing Cap
Material	PEEK (polyetherether ketone)	Ultem 1010-1101(polyetherimide)	PEEK (polyetherether ketone)	PMMA AcrylicCP-1000-IG
Fit	Mates uniquely withshape of shortabutment.	Mates uniquely withshape of shortabutment.	Hexagonconnection	Mates uniquelywith shape ofShort abutment.

7. Technological Characteristics

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DesignFeature	Has indexing / antirotation feature	Has indexing / antirotation feature	Straight or angled,collar heights in 1or 4mm. Groovesfor retention,defined margin	Has indexing /anti rotationfeature
-------------------	-----------------------------------------	-----------------------------------------	---------------------------------------------------------------------------------------------------	--------------------------------------------

Non-Clinical Testing: 8.

Non-clinical test data was not used to support the decision of safety and effectiveness. Clinical literature and material mechanical prosperities indicated that the device is strong enough to withstand the anticipated forces and demonstrated improvements over the predicate devices.

9. Clinical Testing

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

Conclusion 10.

Based on our analysis, the device is substantially equivalent to the predicates and it is considered that the new device is as safe and effective for its intended use and performs as well or better than the predicate device(s).

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Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three lines forming the wings and a snake winding around a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

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

Mr. Jeremy Markovich Regulatory Affairs Zimmer Dental Incorporated 1900 Aston Avenue Carlsbad. California 92008

JAN 2 3 2012

Re: K113092

Trade/Device Name: Zimmer® Contour Provisional Coping Zimmer® Short Provisional Coping Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: January 11, 2012 Received: January 17, 2012

Dear Mr. Markovich:

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 - Mr. Markovich

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 vours.

Nr for

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

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Image /page/6/Picture/0 description: The image shows a logo for Zimmer Dental. The logo consists of a stylized letter "Z" inside a circle, with the word "zimmer" written in lowercase letters below it. Underneath "zimmer" is the word "dental" in a smaller font size. The logo appears to be for a dental-related company or service.

510k No.: A4-1 Page No .:

Zimmer® Contour Provisional Coping Zimmer® Short Provisional Coping

Indications for Use

510(k) Number (if known): _

Device Name: Zimmer® Contour Provisional Coping Zimmer® Short Provisional Coping

Indications For Use:

1 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)

Swear Puane

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

510(k) Number: K113092

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.)