ITI DENTAL IMPLANT SYSTEM

K983742 · Institut Straumann AG · DZE · Mar 15, 1999 · Dental

Device Facts

• Record ID: K983742
• Device Name: ITI DENTAL IMPLANT SYSTEM
• Applicant: Institut Straumann AG
• Product Code: DZE · Dental
• Decision Date: Mar 15, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The ITI All-in-One Dental Implants are intended to be placed in the maxillary and/or mandibular arch to support crowns, bridges or overdentures in edentulous or partially edentulous patients.

Device Story

ITI All-in-One Dental Implants are screw and cylinder type endosseous dental implants. Fabricated from CP titanium (Grade 4), they feature a rough surface for osseointegration in bone and a smooth machined surface for transmucosal attachment. Available in various diameters and lengths. Used by dental professionals in clinical settings to support prosthetic restorations (crowns, bridges, overdentures) in edentulous or partially edentulous patients. The device provides a stable foundation for dental prosthetics, facilitating oral rehabilitation.

Clinical Evidence

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

Technological Characteristics

Material: CP titanium, Grade 4. Design: Screw and cylinder type endosseous dental implant. Surface: Rough surface for bone contact, smooth machined surface for transmucosal attachment. Form factor: Various diameters and insertion lengths.

Indications for Use

Indicated for surgical placement in the maxillary and/or mandibular arch to support crowns, bridges, or overdentures in edentulous or partially edentulous patients.

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 Implants (K894593)
• ITI Dental Implants (K894595)
• ITI Dental Implants (K971578)
• Nobel Biocare Branemark Implants
• Lifecore Dental Implant (K954512)
• Lifecore Dental Implant (K960288)
• Implant Innovations (K954347)
• Implant Innovations (K960417)

Submission Summary (Full Text)

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3/5/99

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# ATTACHMENT 9 - 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. .

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

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

ITI Dental Implants (K894593, K894595, K971578) Nobel Biocare Branemark Implants Lifecore Dental Implant (K954512, K960288) Implant Innovations (K954347, K960417)

#### 4. Description of the Device

The All-in-One implants are screw and cylinder type dental implants made from CP titanium, Grade 4. They are available in various diameters and insertion lengths. The implants have the same rough surface as cleared ITI endosseous implants. The transmucosal part has a smooth machined surface to allow for the attachment of epithelial tissue.

#### Intended Use of the Device રું.

The ITI All-in-One Dental Implants are intended to be placed in the maxillary and/or mandibular arch to support crowns, bridges or overdentures in edentulous or partially edentulous patients.

#### Basis for Substantial Equivalence 6.

The modified ITI dental implants are substantially equivalent to ITI Dental Implants, the Nobel Biocare Branemark implants, Lifecore and Implant Innovations Dental Implants in intended use, material and design.

The modified ITI dental implants have the same intended use as the current ITI dental implants, the Nobel Biocare Branemark implants, Lifecore and Implant Innovations dental implants.

The modified ITI implants are composed of the same material and have the same surface as the cleared ITI dental implants. In addition, the design of the modified ITI implants is similar to the cleared ITI implants. The implant has a rough surface in contact with bone for osseointegration and a smooth titanium surface in contact with mucosa. The range of diameters and lengths of the modified implants are also similar to the commercially available Nobel Biocare Branemark, Lifecore (K960288) and Implant Innovations (K954347) implants.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 5 1999

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

Re : K983742 ITI Dental Implant System® Trade Name: Regulatory Class: III Product Code: DZE Dated: January 22, । ਭੇਰੇ ਰ Received: January 25, 1999

Dear Ms. Jalbert:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of

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Page 2 - Ms. Jalbert

the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely Yours,

Timothy A. Ulatowski

Directbr Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use Statement

Device Name:

,

ITI Dental Implants

# Indications for Use:

ITT dental implants are intended for surgical placement in the maxillary and/oular I II dental implants are mended for surgical placement in also handing and our partially edentulous patients.

Susan Runner

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number _ 6482740

**Prescription Use**
(Per 21 CFR 801.109)

Prescription Use -------------------------------------------------------------------------------------------------------------------------------------------------------------

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