ITI implants are intended for surgical placement in the maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients. The ITI Dental Implants are for single-stage or two-stage surgical procedures.

Device Description

ITI implants have an anchorage surface that is grit blasted then acid etched (SLA surface) or titanium plasma-sprayed (TPS surface). The implants are composed of Grade 4 titanium, cold worked. The neck of the implant, intended to remain above the crest of the bone on implantation, is a smooth machined surface to allow for the attachment of epithelial tissue. ITI implants are available in a range of endosseous diameters (3.3 to 4.8 mm) and lengths.

AI/ML Overview

This document is a 510(k) Summary for the ITI® Dental Implant System. It primarily focuses on demonstrating substantial equivalence to predicate devices and does not describe a study involving specific acceptance criteria or device performance data for this product.

Therefore, I cannot fully answer your request based on the provided text. The document states:

"The subject ITI® implants are identical in all respects to previously cleared ITI implants. There has been no change in material, surface treatment, design, or operating principle."

This indicates that the submission is for a device that is essentially the same as a previously cleared one, and as such, detailed performance studies with acceptance criteria are typically not required. The basis for substantial equivalence is the identity of the device to its predicate.

However, I can extract information related to the device and its regulatory context:

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

Not applicable. The document does not describe acceptance criteria or reported device performance for a new study. Instead, it asserts that the device is identical to previously cleared devices.

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

Not applicable. No test set or data provenance is mentioned as no new performance study was conducted.

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 for a test set is discussed.

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

Not applicable. No test set or adjudication method is described.

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 document pertains to dental implants, not AI-assisted reading or diagnostic devices.

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

Not applicable. This document pertains to dental implants, not algorithms.

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

Not applicable. No new ground truth was established as no new performance study was described.

8. The sample size for the training set

Not applicable. No training set for a new study is mentioned.

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

Not applicable. No training set or ground truth establishment is described.

Summary of what the document does indicate:

Device Name: ITI® Dental Implant System
Indications for Use: Surgical placement in maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients, for single-stage or two-stage surgical procedures.
Predicate Devices: ITI Dental Implant System and Implant Innovations Inc. Osseotite Dental Implants (K013570).
Basis for Substantial Equivalence: The device is identical in intended use, material, surface treatment, design, and operating principle to previously cleared ITI implants. The contraindication regarding tobacco use has also been removed, aligning with the predicate Implant Innovations Inc. Osseotite Dental Implants.
Device Components: Grade 4 titanium (cold worked), grit blasted and acid-etched (SLA surface) or titanium plasma-sprayed (TPS surface) anchorage surface, smooth machined neck. Available in diameters from 3.3 to 4.8 mm and various lengths.
Regulatory Classification: Class III, Product Code DZE, Regulation Number 21 CFR 872.3640 (Endosseous Implants).

Summary

{0}------------------------------------------------

031055

ATTACHMENT 6

510(k) Summary

JUL 0 7 2003

1. Applicant's Name and Address

Straumann USA (on behalf of Institut Straumann AG) Reservoir Place 1601 Trapelo Road Waltham, MA 02451 Telephone Number: 800-448-8168 Fax Number: 781-890-0791 Linda Jalbert Contact Person: Director, Requlatory Affairs

2. Name of the Device

Trade Name: ITI® DENTAL IMPLANT SYSTEM Common Name: Endosseous dental implants Classification Name: Endosseous dental implants 21 CFR 872.3640

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

ITI Dental Implant System Implant Innovations Inc. Osseotite Dental Implants(K013570)

Description of the Device 4.

5. Indications for Use

{1}------------------------------------------------

Basis for Substantial Equivalence 6.

The subject ITI® dental implants are identical in intended use to currently marketed ITI® dental implants. As with the predicate device, Implant Innovations Inc. Osseotite Dental Implants, the contraindication regarding tobacco use has been removed.

The subject ITI® implants are identical in all respects to previously cleared ITI implants. There has been no change in material, surface treatment, design, or operating principle.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The caduceus is composed of three curved lines that resemble a human profile. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 0 7 2003

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

Re: K031055

Trade/Device Name: ITI® Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Implant Regulatory Class: III Product Code: DZE Dated: April 2, 2003 Received: April 9, 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 vour 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.

{3}------------------------------------------------

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 vours.

Susan Puarer

Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

ﺎﺕ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ Enclosure

{4}------------------------------------------------

ATTACHMENT 8

Indications for Use Statement

Device Name:

ITI® Dental Implant System

Indications for Use:

Kim Rudy for MSN

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

510(k) Number:________________________________________________________________________________________________________________________________________________________________

ity
A

Regulation Number and Section

§ 872.3640 Endosseous dental implant.

(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. 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.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.