Healing Caps are intended for placement onto dental implants to protect the inner configuration and shoulder of the implant and to maintain, stabilize and form the soft tissue during the healing phase.

Device Description

The Straumann Dental Implant System is an integrated system of endosseous dental implants, which are designed to support prosthetic devices for partially or fully edentulous patients. The system consists of a variety of dental implants, permanent and temporary abutments, healing caps and surgical and prosthetic parts and instruments. The device covered in this submission is a healing cap.

AI/ML Overview

This submission does not contain a study that proves the device meets specific acceptance criteria using reported performance metrics. Instead, the 510(k) summary for the "RN Healing Cap, Concave" relies on substantial equivalence to a previously cleared predicate device (RN Esthetic Healing Caps, K960634).

Here's a breakdown of why and what information is available based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Not applicable. The submission explicitly states: "The proposed healing cap is substantially equivalent to the currently cleared device. The intended use, material, basic design and fundamental operating principles are identical to the predicate device." This means the performance is assumed to be equivalent to the predicate, and no new performance data or acceptance criteria are presented for this specific device in this document.

2. Sample size used for the test set and the data provenance:

Not applicable. No new test set data is presented.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. No new test set data is presented.

4. Adjudication method for the test set:

Not applicable. No new test set data is presented.

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:

Not applicable. This is a medical device (healing cap for dental implants), not an AI-powered diagnostic or comparative effectiveness study involving human readers.

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

Not applicable. This is a physical medical device.

7. The type of ground truth used:

Not applicable. There is no new ground truth established for this submission. The basis for clearance is substantial equivalence to a predicate device. The "ground truth" here is the established safety and effectiveness of the predicate device.

8. The sample size for the training set:

Not applicable. This is not an AI/machine learning device.

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

Not applicable. This is not an AI/machine learning device.

Summary of Acceptance and Evidence:

The "acceptance criteria" in this context are primarily regulatory: demonstrating substantial equivalence to a legally marketed predicate device. The "study" proving this is a comparison of technological characteristics and intended use, rather than a clinical trial or performance study of the new device itself.

The key points from the provided text are:

Acceptance Criteria (Implicit): The device must be "substantially equivalent" to a predicate device (RN Esthetic Healing Caps, K960634) in terms of intended use, material, basic design, and fundamental operating principles.
Proof of Meeting Acceptance Criteria: The submission states that "The proposed healing cap is substantially equivalent to the currently cleared device. The intended use, material, basic design and fundamental operating principles are identical to the predicate device." This statement, along with detailed device descriptions (which are not fully provided in the given text but would be part of a complete 510(k) submission), serves as the "proof" for regulatory clearance based on substantial equivalence. No new performance data is presented or required for a 510(k) based solely on substantial equivalence.

Summary

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K081186

Section I 510(k) Summary

MAY 2 3 2008

1. Applicant's Name and Address

Straumann US (on behalf of Institut Straumann AG) 60 Minuteman Rd. Andover, MA 01810 Telephone Number: 800-448-8168, ext 2513 Fax Number: 978-747-0023 Contact Person: Elaine Alan Regulatory Affairs Specialist Date of Submission: April 25, 2008

2. Name of the Device

Trade Name:	RN Healing Cap, Concave
Common Name:	Abutment, Dental, Endosseous implants
Classification Name:	Abutment, Dental, Endosseous implants
Regulation Number:	§872.3630

1. Legally Marketed Device to which Equivalence is Claimed (Predicate Device)
  RN Esthetic Healing Caps, K960634

4. Description of the Device

5. Intended Use of the Device

Healing caps are intended to be placed into dental implants to protect the inner configuration and shoulder of the implant and to maintain, stabilize and form the soft tissue during the healing phase.

6. Technological Characteristics

The proposed healing cap is substantially equivalent to the currently cleared device. The intended use, material, basic design and fundamental operating principles are identical to the predicate device.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 3 2008

Institut Straumann AG C/O Ms. Elaine Alan Regulatory Affairs Specialist Straumann USA 60 Minuteman Road Andover, Massachusetts 01810

Re: K081186

Trade/Device Name: RN Healing Cap, Concave Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: April 25, 2008 Received: April 28, 2008

Dear Ms. Alan:

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 such 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. Alan

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Sasa Runa

Chiu Lin, Ph.D. 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 Statement

KO81186

Device Name: RN Healing Cap, Concave

Indications for Use:

× Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Supe Quano

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

510(k) Number:

ber. KCS 11856

510(k) Submission: RN Healing Cap, Concave April 25, 2008

Straumann US Page 5

Proprietary and Confidential

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.)