The device that is the subject of this submission is an angled titanium coping, which is a pre-manufactured component offering a pre-formed inner surface for mating with the dental implant abutment. The outer surface of the coping can be adapted to the individual restoration. The coping is angled and is used only with the ITI anterior implant.

Device Description

The ITI 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, abutments, and surgical and prosthetic parts and instruments. The devices covered by this submission are titanium anqled copings for the ITI anterior implant.

AI/ML Overview

This document describes a 510(k) premarket notification for a dental device, specifically a "Titanium coping for ITI anterior implant." The information provided in the document is for a traditional device submission and does not include any details on acceptance criteria or a study proving that a device meets such criteria.

The document states that the device is "substantially equivalent to previously cleared ITI copings," and its "intended use...is identical to the predicate copings." This suggests that the substantial equivalence was likely established through a comparison of material properties, design features, and intended use with the predicate devices, rather than through a performance study with specific acceptance criteria that would typically be associated with new or significantly modified medical devices, especially those involving AI or complex functionalities.

Therefore, your request for the following information cannot be fulfilled based on the provided text:

A table of acceptance criteria and the reported device performance: Not provided.
Sample sized used for the test set and the data provenance: Not provided. The submission appears to be based on design and material comparisons, not performance testing on a "test set."
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no test set or ground truth establishment relevant to AI/performance studies is mentioned.
Adjudication method for the test set: Not applicable.
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 device is not an AI-powered diagnostic or assistive tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used: Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Summary

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AUG 2 7 2003

K032498

ATTACHMENT 5 - 510(k) Summary

1. Applicant's Name and Address

Straumann USA (on behalf of Institut Straumann AG) Reservoir Place 1601 Trapelo Road Waltham, MA 02451 Telephone Number: 781-890-0001 781-890-6464 Fax Number: Linda Jalbert Contact Person: Director, Requlatory Affairs

2. Name of the Device

Trade Name: Common Name: Classification Name:

Titanium coping for ITI anterior implant Endosseous dental implants Endosseous dental implants 21 CFR 872.3640

3. Legally Marketed Devices to which Equivalence is Claimed (Predicate Devices)

ITI Gold coping for anterior implant (K010921) SynOcta milling cylinders (K022859)

র্বা Description of the Device

5. Intended Use of the Device

The ITI Dental Implant System is an integrated system of endosseous dental implants which are designed to support prosthetic devices (crowns, bridges, and overdentures) for partially and fully edentulous patients. The system consists of a variety of dental implants, abutments, copings and other surgical and prosthetic parts and instruments.

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Basis for Substantial Equivalence 6.

The subject devices are substantially equivalent to previously cleared ITI copings. The intended use of the subject coping is identical to the predicate copings.

: 上一篇:

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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 circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings and head.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 7 2003

Ms. Linda Jalbert Director of Regulatory Affairs Straumann USA Reservoir Place 1601Trapelo Road Waltham, Massachusetts 02451

Re: K032498

Trade/Device Name: Titanium Coping for the ITI Anterior Implant Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implants Regulatory Class: III Product Code: NHA Dated: August 8, 2003 Received: August 16, 2003

Dear Ms. Jalbert:

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. Jalbert

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 (301) 594-4613. 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/dsma/dsmamain.html

Sincerely yours,

Susan Runrer

Susan Runner, DDS, MA Interim Direction 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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Ko32498 510(k) Number (if known):

Titanium coping for the ITI Anterior implant Device Name:

Indications For Use:

Kein Mulvey for MSD

y, General Hospital.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

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.)