The Healing Collar is used to assist in the forming of the soft tissue during healing before a final restoration is placed. The Healing Collar is for single use only.

Device Description

The healing collar is designed to form the soft tissue during the healing period before a final restoration is placed. The device is threaded onto the implant immediately after implant placement in a one-stage protocol. In a two-stage protocol, the healing collar is placed on the implant following the bone healing period. The soft tissue is sutured around the healing collar and the device remains in the mouth until the soft tissue fully develops. Depending on the needs of the patient, various healing collar sizes are available to interface with the implant and also to properly form the soft tissue. Healing collars are offered with three distinct implant platform diameters to accommodate for the different implant platform sizes. They are also available in differing cuff heights and emergence profile diameters to assist in forming the soft tissue. Because of the various sizes available, certain features are being incorporated into the design to assist in identifying the healing collars visually: The bottom half of the healing collar will be colored according to 1.) the shade that defines its respective implant platform size. The top face will be etched with all size parameters related to the 2.) use of the healing collar: implant platform diameter, emergence profile diameter, cuff height.

AI/ML Overview

Here's an analysis of the provided text regarding acceptance criteria and supporting studies:

This document describes a 510(k) premarket notification for a device modification – specifically, the addition of an anodization process to an existing healing collar. Crucially, the document explicitly states that no non-clinical or clinical testing was performed to establish new acceptance criteria or prove device performance for this modification. Instead, the submission relies on the substantial equivalence to a predicate device.

Therefore, many of the requested sections regarding specific testing details will not be applicable based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance	Comments
Design Equivalence	1. Dimensions	"dimensionally identical" to current Healing Collars.	No specific performance data provided beyond statement of equivalence.
	2. Material	"same as the Healing Collar Predicate Device"	No specific performance data provided beyond statement of equivalence.
	3. Implant Interface	"same as the Healing Collar Predicate Device"	No specific performance data provided beyond statement of equivalence.
	4. Function in System	"same as the Healing Collar Predicate Device"	No specific performance data provided beyond statement of equivalence.
Mechanical Performance	1. Load Bearing	Not a load-bearing component; placed out of occlusion.	"experience minimal mechanical forces."
Biocompatibility	(Implicit, not explicitly stated as criteria in this document)	(Not addressed in the provided text in terms of new testing or performance data for the anodized version.)	Presumably, the predicate device had established biocompatibility, and the anodization process is assumed not to introduce new bioincompatibilities requiring further testing.
New Features	1. Color Coding	"bottom half... will be colored according to... implant platform size"	Descriptive only; no performance criteria are met, but rather a characteristic.
	2. Etched Parameters	"top face will be etched with all size parameters"	Descriptive only; no performance criteria are met.

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

Sample Size for Test Set: Not applicable. No test set was used for this modification.
Data Provenance: Not applicable. No new data from testing was generated for this submission. The basis for equivalence is the existing predicate device.

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

Not applicable. No ground truth for a test set was established as no new testing was performed.

4. Adjudication Method 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

No. An MRMC comparative effectiveness study was not done, as no clinical or even new non-clinical testing was performed.

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

Not applicable. This device is a physical healing collar, not software or an algorithm.

7. The Type of Ground Truth Used

Not applicable for the modified device. The submission relies entirely on the ground truth established for the predicate device, which is implicitly safe and effective based on its prior 510(k) clearance (K953101).

8. The Sample Size for the Training Set

Not applicable. This device is a physical healing collar, not a machine learning model.

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

Not applicable. This device is a physical healing collar.

Summary of the Document's Approach:

The provided document details a 510(k) Special Notification for a device modification, specifically adding an anodization process for color-coding. The core argument for clearance is substantial equivalence to a previously cleared predicate device (Paragon Implant System, K953101).

The manufacturer explicitly states:

"Non-clinical testing was not performed."
"No clinical testing was performed."

The justification for not performing testing is that:

The healing collars are not load-bearing components ("placed out of occlusion and experience minimal mechanical forces").
The design and function, material, implant interface, and dimensions of the anodized healing collars are equivalent to the existing (predicate) healing collars.
Therefore, the mechanical properties of the material are sufficient, loading conditions remain the same, and the anodization does not present a "new worst case."

In essence, the "study" proving the device meets acceptance criteria is the argument of substantial equivalence based on the predicate device's established safety and effectiveness, rather than new testing data. The "acceptance criteria" for the modified device are implicitly met because its fundamental design and function are identical to the predicate, with the anodization being a surface treatment for identification that does not alter mechanical properties or intended use in a way requiring new performance validation.

Summary

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

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

111852 510k No.:

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

A5-1 Page No .:

AUG 1 1 2011

ﮩﺴ

pecial 510(k): Device Modification -MARKET NOTIFICATION 510(k) 510(k) SUMMARY (21CFR807.92(a))

Anodized Healing Collar

872.3630 NHA

1. Submitter's Information:

Name:	Zimmer Dental Inc.
Address:	1900 Aston Ave. Carlsbad, CA 92008
Phone:	760-929-4300
Contact:	Melissa Burbage
Date Prepared:	June 28, 2011

1. Device Name:

Trade Name:
Regulation Number:
Classification Code:

Predicate Device(s): Trade Name:

510(k) No: Requlation Number: Classification Code:

Paragon Implant System (now known as Tapered Screw-Vent System) K953101 872.3640 DZE

Device Description: র্বা

Depending on the needs of the patient, various healing collar sizes are available to interface with the implant and also to properly form the soft tissue. Healing collars are offered with three distinct implant platform diameters to accommodate for the different implant platform sizes. They are also available in differing cuff heights and emergence profile diameters to assist in forming the soft tissue. Because of the various

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

sizes available, certain features are being incorporated into the design to assist in identifying the healing collars visually:

The bottom half of the healing collar will be colored according to 1.) the shade that defines its respective implant platform size.

The top face will be etched with all size parameters related to the 2.) use of the healing collar: implant platform diameter, emergence profile diameter, cuff height.

Indications for Use: 5.

The Healing Collar is used to assist in the forming of the soft tissue during healing before a final restoration is placed. The Healing Collar is for single use only.

Device Comparison: 6.

The new device is equivalent in design with Healing Collar Predicate. The new device has an added manufacturing process of anodization to allow for color coding. The device dimensions specifications, material, implant interface, and function in the system remains the same as the Healing Collar Predicate Device.

7. Non-Clinical Testing:

Non-clinical testing was not performed. The Healing Collars are not load bearing components, they are placed out of occlusion and experience minimal mechanical forces. Since the design and function of the Anodized Healing Collars is equivalent to the existing Healing Collars, the mechanical properties of the material are sufficient for the function of the part. In addition, because the two part families are dimensionally identical, the Anodized Healing Collars will interface with mating components in the same manner as the current Healing Collars. Therefore, any loading conditions will remain the same and the Anodized Healing Collars do not present a new worst case when compared to the Healing Collars. As a result, mechanical testing is not necessary.

Clinical Testing 8.

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

1. Conclusion

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

Based on our analysis, the device is substantially equivalent to the Baoou off our analyders the new device is as safe and effective for its intended use and performs as well the predicate device.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

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

Ms. Melissa Burbage Manager, Regulatory Affairs Zimmer Dental, Incorporated 1900 Aston Avenue Carlsbad, California 92008-7308

AUG 1 1 2011

Re: K111852

Trade/Device Name: Anodized Healing Collar Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: August 1. 2011 Received: August 2, 2011

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.

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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/ucm 1 15809.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.

hn 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

Enclosure

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Indications for Use **

111828 510(k) Number (if known):

Device Name: Anodized Healing Collar

Indications For Use:

ﺔ ﺑﺎﻟﻘﺎﺑﺔ

The Healing Collar is used to assist in the forming of the soft tissue during healing before a final restoration is placed. The Healing Collar is for single use only.

× 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)

Swsa Runne

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

1411852 510(k) Number:

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.)