ITI DENTAL IMPLANT SYSTEM

K030007 · Straumann USA · DZE · Mar 31, 2003 · Dental

Device Facts

• Record ID: K030007
• Device Name: ITI DENTAL IMPLANT SYSTEM
• Applicant: Straumann USA
• Product Code: DZE · Dental
• Decision Date: Mar 31, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The ITI dental implants are intended for immediate placement and function on singletooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients 4 or more implants must be used.

Device Story

Endosseous dental implants for tooth replacement; Grade 4 cold-worked titanium construction; external spiral screw thread design; surface options include grit-blasted/acid-etched (SLA) or titanium plasma-sprayed (TPS). Smooth machined neck allows epithelial tissue attachment. Implants placed surgically into jawbone by dental professionals; intended for immediate function when primary stability is achieved. Restores chewing function for single or multiple tooth applications; multiple implants may be splinted. Benefits include restoration of oral function and aesthetics.

Clinical Evidence

No clinical data provided; substantial equivalence based on identical design, materials, and intended use to previously cleared predicate devices.

Technological Characteristics

Grade 4 cold-worked titanium; external spiral screw thread; surface treatments: grit-blasted/acid-etched (SLA) or titanium plasma-sprayed (TPS); smooth machined neck; diameters 3.3-4.8 mm; various lengths.

Indications for Use

Indicated for patients requiring single or multiple tooth replacement, including edentulous patients (minimum 4 implants), where good primary stability and appropriate occlusal loading can be achieved to restore chewing function.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• ITI Dental Implant System (K984104)
• ITI Dental Implant System (K003552)
• Branemark System Implants (K022562)

Submission Summary (Full Text)

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K030007

MAR 3 1 2003

## ATTACHMENT 6

## 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 Fax Number: 781-890-6464 Contact Person: Linda Jalbert Director, Regulatory 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 |

### ന് Legally Marketed Devices to which Equivalence is Claimed (Predicate Devices)

ITI Dental Implant System (K984104, K003552) Various Branemark System Implants (K022562)

### 4. Description of the Device

ITI solid screw implants have an external spiral screw thread and an anchorage surface that is grit blasted then acid etched (SLA surface) or titanium plasmasprayed (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.

#### 5. Indications for Use

Like the predicate Branemark implants, the ITI Dental System implants are intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients 4 or more implants must be used.

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### Basis for Substantial Equivalence 6.

The subject ITI® dental implants are identical in intended use to currently marketed ITI® dental implants, and the indications for use covered in this 510(k) are the same as that of the predicate Branemark system dental implants.

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.

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Image /page/2/Picture/1 description: The image is a black and white 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 three human profiles facing right, with flowing lines representing hair or clothing.

Public Health Service

Food and Drug Administration

9200 Corporate Boulevard Rockville MD 20850

MAR 3 1 2003

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

Re: K030007

Trade/Device Name: ITI® Dental Implant System Regulation Number: 872.3640 Regulation Name: Endosseous Dental Implants Regulatory Class: III Product Code: DZE Dated: December 31, 2002 Received: January 1, 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 (OS) 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 vour 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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Susan Ramos

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

Enclosure

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K030007

Page 45 of 46

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name:_ ITI Dental Implant System

Indications For Use:

The ITI dental implants are intended for immediate placement and function on singletooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients 4 or more implants must be used.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | <span style="text-decoration: overline;">X</span> | OR | Over-The-Counter Use |
|----------------------|---------------------------------------------------|----|-----------------------|
| (Per 21 CFR 801.109) | | | (Optional Format 1-2- |

96)

| (Division Sign-Off) | <span style="text-decoration: underline;">Keri Mely for MSR</span> |
|---------------------|--------------------------------------------------------------------|
| | Division of Anesthesiology, General Hospital, |
| | Infection Control, Dental Devices |
| 510(k) Number: | <span style="text-decoration: underline;">K030007</span> |