STRAUMANN DENTAL IMPLANT SYSTEM

K033984 · Institut Straumann AG · DZE · Jun 30, 2004 · Dental

Device Facts

• Record ID: K033984
• Device Name: STRAUMANN DENTAL IMPLANT SYSTEM
• Applicant: Institut Straumann AG
• Product Code: DZE · Dental
• Decision Date: Jun 30, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

For immediate or delayed placement in the maxillary and/or mandibular arches to support crowns, bridges and overdentures in edentulous or partially edentulous patients.

Device Story

The ITI Dental Implant System consists of endosseous dental implants used to support dental prosthetics. Implants are surgically placed into the maxillary or mandibular arches. The device features a modified surface (grit-blasted and acid-etched) designed to accelerate osseointegration and improve secondary stability compared to previous iterations. The implant neck is smooth-machined to facilitate epithelial tissue attachment. The device is used by dental clinicians in a clinical setting. By providing a stable anchor for crowns, bridges, and overdentures, the implant restores chewing function for patients. The modified surface allows for earlier loading procedures during the healing phase.

Clinical Evidence

No human clinical data provided. Evidence consists of animal studies demonstrating improved bone-to-implant contact and earlier secondary stability at 2-4 weeks healing periods for the modified surface compared to the predicate SLA surface.

Technological Characteristics

Endosseous dental implant; material: Grade 4 cold-worked titanium; surface: grit-blasted and acid-etched; diameters: 3.3 to 4.8 mm; design: solid screw with smooth-machined neck; energy source: none (mechanical); sterilization: not specified.

Indications for Use

Indicated for single-stage or two-stage surgical procedures in edentulous or partially edentulous patients. Intended for immediate placement and function on single or multiple tooth applications to restore chewing function, provided good primary stability is achieved and appropriate occlusal loading is applied. Multiple tooth applications may be rigidly splinted. In edentulous patients, 4 or more implants are required for immediate loading.

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 (K971578, K983742, K984104, K003271, K010291, K012757, K030007)
• Friadent CELLplus implants (K031674, K032158, K032284)

Submission Summary (Full Text)

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## ATTACHMENT 6 - 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: Linda Jalbert, Director of Regulatory Affairs Contact Person:

#### Name of the Device 2.

ITI Dental Implant System® Trade Name: Dental Implant Common Name: Endosseous Dental Implant (21 CFR 872.3640) Classification Name:

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

ITI Dental Implant System (K971578, K983742, K984104, K003271, K010291, K012757 and K030007) Friadent CELLplus implants (K031674, K032158, K032284)

#### Description of the Device 4.

The Straumann solid screw dental implants are of various diameters and lengths with an anchorage surface that is grit blasted and acid etched. This surface has been modified for faster osseointegration and secondary stability. The dental implants are composed of Grade 4 titanium, cold worked. The neck of the implant is a smooth machined surface to allow for the attachment of epithelial tissue. Straumann implants are available in a range of endosseous diameters (3.3 to 4.8 mm) and lengths. No changes to overall implant design or dimensions were made.

#### Intended Use of the Device ട്.

For immediate or delayed placement in the maxillary and/or mandibular arches to support crowns, bridges and overdentures in edentulous or partially edentulous patients.

#### Basis for Substantial Equivalence 6.

The subject dental implants are identical to the currently marketed ITI dental implants in intended use, material and design. The subject SLActive dental implants have the same indications for use as the currently marketed ITI dental implants. The subject device is the same as the currently marketed ITI dental implants with a modified surface. This surface promotes faster osseointegration. Increased bone to implant contact and earlier secondary stability with the modified surface compared to the SLA surface was demonstrated at early healing periods of 2-4 weeks in animal studies. This improved bone anchorage

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provides increased implant stability during the important early treatment periods provided increasing loading procedures.

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, represented by three curved lines that suggest the shape of a bird in flight.

### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUN 3 0 2004

Institut Straumann AG C/O Ms. Linda Jalbert Director, Regulatory Affairs Straumann USA 1601 Trapelo Road Waltham, Massachusetts 02451

Re: K033984

Trade/Device Name: ITI Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Implant Regulatory Class: II Product Code: DZE Dated: April 13, 2004 Received: April 14, 2004

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 Eederal 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 [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,

Chiu Lin, Ph.D.

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): K033984

Device Name: ITI Dental Implant System

Indications for Use: The ITI Dental System implants are for single-stage or two-stage surgical procedures. 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 in immediately loaded cases.

Susan Quare

(Division Sign-Off) (Division of Anesthesiology, General Hospital, Infection Control, Dental Devices 510(k) Number:

Prescription Use X X . . . (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

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

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

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