MODIFICATION TO ITI DENTAL IMPLANT SYSTEM

K033922 · Institut Straumann AG · DZE · Jan 7, 2004 · Dental

Device Facts

• Record ID: K033922
• Device Name: MODIFICATION TO ITI DENTAL IMPLANT SYSTEM
• Applicant: Institut Straumann AG
• Product Code: DZE · Dental
• Decision Date: Jan 7, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

ITI implants are surgically placed in the maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients. ITI Dental Implants are for single-stage or two-stage surgery. The implants are intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. Multiple tooth applications oon be rigidly splinted. In the case of edentulous patients, four or more implants must be used.

Device Story

Endosseous dental implants; solid screw design; composed of Grade 4 commercially pure titanium; feature SLA surface (grit blasted and acid etched). Surgically placed in maxillary or mandibular arches by dental professionals; used for single-stage or two-stage procedures. Provides support for prosthetic restorations in edentulous or partially edentulous patients; enables immediate placement and function when primary stability is achieved. Restores chewing function; multiple tooth applications may be rigidly splinted; minimum of four implants required for edentulous cases.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design, material, and intended use similarities to legally marketed predicate devices.

Technological Characteristics

Material: Grade 4 commercially pure titanium. Surface treatment: SLA (grit blasted and acid etched). Design: Solid screw endosseous dental implant. Available in various lengths and diameters. No software or electronic components.

Indications for Use

Indicated for edentulous or partially edentulous patients requiring prosthetic restoration support in maxillary or mandibular arches. Suitable for single-stage or two-stage surgery. Intended for immediate placement and function on single or multiple tooth applications, provided good primary stability and appropriate occlusal loading are achieved. For edentulous patients, a minimum of four implants is required.

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 Esthetic PLUS Solid Screw Implants (K983742)
• ITI Esthetic PLUS Solid Screw Implants (K030007)

Submission Summary (Full Text)

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### JAN - 7 2004

# K033922

### ATTACHMENT 7 - 510(k) Summary

#### Applicant's Name and Address 1 .

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

#### 2. Name of the Device

| Trade Name: | ITI® DENTAL IMPLANT SYSTEM<br>(Standard PLUS implants) |
|----------------------|--------------------------------------------------------|
| Common Name: | Endosseous dental implants |
| Classification Name: | Endosseous dental implants<br>21 CFR 872.3640 |

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

ITI Esthetic PLUS Solid Screw Implants (K983742 and K030007)

#### Description of the Device এ -

The ITI Standard PLUS implants are modifications of the currently distributed ITI Esthetic PLUS implants. The subject implant is a solid screw with an SLA surface (grit blasted then acid etched). The implants are composed of Grade 4 commercially pure titanium and are available in a range of lengths and diameters.

#### റ്റ് . Intended Use of the Device

ITI implants are surgically placed in the maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous

> 510{k} ITl® Dental Implant System 12/16/03 Page 39 of 44

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patients. ITI Dental Implants are for single-stage or two-stage surgery. The implants are intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. Multiple tooth applications oon be rigidly splinted. In the case of edentulous patients, four or more implants must be used.

#### Basis for Substantial Equivalence 6.

The subject ITI dental implants are substantially equivalent to the previously cleared ITI Esthetic PLUS implants. The intended use is identical to the predicate device. ITI implants are surgically placed in the maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients. ITI Dental Implants are for single-stage or two-stage surgery. The implants are intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, four or more implants must be used.

The subject ITI implants have the same material composition and the same surface treatment as previously cleared ITI implants. In addition, the design of the modified implant is almost identical to the previously cleared Esthetic PLUS implants.

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized wings or feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN - 7 2004

Institut Straumann AG C/O Ms. Carolyn Bitetti Assistant Director, Regulatory Affairs Straumann USA Reservoir Place 1601 Trapelo Road Waltham, Massachusetts 02451

Re: K033922

Trade/Devicc Name: Modification To ITI Dental Implant System Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: III Product Code: DZE Dated: December 15, 2003 Received: December 18, 2003

Dear Ms. Bitetti:

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 mendments, or to devices that have been reclassified in accordance with the provisions of Amendment, of to do rood Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls provisions of a 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 (1 Writ), it har be bacyse in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Eederal Register.

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Page 2 - Ms. Bitetti

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 inteall that 1271 has made a autes and regulations administered by other l'ederal agencies. of the Act of ally I edelur statues and reguirements, including, but not limited to: registration 1 ou must comply with an are rebeling (21 CFR Part 801); good manufacturing practice allu listing (21 CF RT art 007), labelity systems (QS) regulation (21 CFR Part 820); and if requirements as set form in the qualify ion 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) This letter will anow you to began time.
The fication. The FDA finding of substantial equivalence of your device to a premits notification. - The Presults 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), If you desire specific at not reserved 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 may votall outer generational 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,

Clu L

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

510(k) Number (if known): K033922

Modification to ITI Dental Implant System Device Name:

### Indications for Use:

ITI implants are intended for surgical placement in the maxillary and/or mandibular ITT linplans are interactions in edentulous in edentulous or partially edentulous patients. ITI Dental Implants are for single-stage or two-stage surgery.

ITI Dental Implants are intended for immediate placement and function on single-tooth IT Doman informations when good primary stability is achieved, with and/or the occlusal loading, in order to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, four or more implants must be used.

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)

Susan Rumm

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510(k) Number: K023622