Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges and overdentures. Abutments can be used in single tooth replacements and multiple tooth restorations.

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 and surgical and prosthetic parts and instruments. The device covered in this submission is an abutment.

The coronal portion of the abutment has an octagon design to interface with the final restoration. The abutment is seated in the implant with a screw that is mounted in the basal portion of the abutment. The abutment is used for cemented and screw-retained restorations.

AI/ML Overview

This document is a 510(k) submission for a dental abutment, not an AI/ML medical device. Therefore, it does not contain the information requested about acceptance criteria or a study demonstrating the device meets those criteria, as these concepts are typically applied to the validation of AI/ML algorithms.

The document primarily focuses on establishing substantial equivalence to a predicate device based on similar intended use and technological characteristics.

Here's why the requested information cannot be extracted from the provided text:

Acceptance Criteria & Device Performance Table: This submission is for a physical medical device (dental abutment). Its "performance" is assessed through material properties, fit, and intended function validation, not through metrics like sensitivity, specificity, or accuracy that would be relevant to an AI/ML algorithm. The document states "The proposed abutment is substantially equivalent to the currently marketed device. The intended use, basic design and fundamental operating principles are the same as the predicate device." This is the core "acceptance criteria" here – similarity to an already approved device.
Sample Size for Test Set & Data Provenance: Not applicable for this type of device submission. There is no "test set" in the context of an algorithm.
Number of Experts & Qualifications for Ground Truth: Not applicable. Ground truth, in the AI/ML context, refers to expertly labeled data. For a dental abutment, the "ground truth" would be established by engineering specifications, material standards, and clinical performance over time, not through labeling of data by experts in a diagnostic sense.
Adjudication Method: Not applicable.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable, as this is a physical device, not a diagnostic algorithm.
Standalone Performance: Not applicable.
Type of Ground Truth Used: The "ground truth" for this device is its physical properties, material compatibility, and structural integrity under anticipated loads, which are confirmed through engineering tests and adherence to manufacturing standards, not through "expert consensus, pathology, or outcomes data" in the AI/ML sense.
Sample Size for Training Set: Not applicable.
How Ground Truth for Training Set Was Established: Not applicable.

In summary, this document describes a traditional medical device submission (a dental abutment) based on substantial equivalence. It does not provide information relevant to the validation of an AI/ML algorithm.

Summary

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Ko 7362 d

Section I 510(k) Summary

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: December 21, 2007

JAN 22 2008

Name of the Device

	Trade Name:	RN synOcta® 1.5 mm Abutment
	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)
  Straumann RN synOcta® 1.5 mm Abutment, K022859

4. Description of the Device

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5. Intended Use of the Device

6. Technological Characteristics

The proposed abutment is substantially equivalent to the currently marketed device. The intended use, basic design and fundamental operating principles are the same as the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 eagle with three stripes representing the agency's mission to promote health, well-being, and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Public Health Service

JAN 22 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K073628

Trade/Device Name: RN synOcta® 1.5mm Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: December 21, 2007 Received: December 26, 2007

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,

Sautge H. Michael Davis.

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

Device Name: RN synOcta® 1.5 mm Abutment

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

Suda Turner

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

510(k) Number: K673625

510(k) Submission: 1.5 mm synOcta Abutment Redesign Proprietary and Confidential December 21, 2007

Straumann US Page 5

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.)