ITI DENTAL IMPLANT SYSTEM

K984104 · Straumann USA · DZE · May 13, 1999 · Dental

Device Facts

• Record ID: K984104
• Device Name: ITI DENTAL IMPLANT SYSTEM
• Applicant: Straumann USA
• Product Code: DZE · Dental
• Decision Date: May 13, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

ITI One Part octa 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. ITI one-part octa implants are for use in edentulous jaws in conjunction with barborne superstructure on 4 implants. If ITI one-part implants are splinted with a bar, they can be loaded immediately. ITI one-part implants can also be used for indications requiring endosseous implants for functional rehabilitation in regions where an ITI two part implant and an Octa abutment would normally be used.

Device Story

Screw-type dental implants; manufactured from CP titanium Grade 4. Device features rough surface for osseointegration in bone and smooth machined surface for transmucosal attachment. Placed surgically in maxillary or mandibular arches by dental professionals to support prosthetic restorations. Enables functional rehabilitation; supports bar-borne superstructures in edentulous jaws; allows immediate loading when splinted. Benefits include structural support for dental prosthetics.

Clinical Evidence

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

Technological Characteristics

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

Indications for Use

Indicated for edentulous or partially edentulous patients requiring functional rehabilitation via endosseous dental implants in the maxillary or mandibular arches. Includes use in edentulous jaws with bar-borne superstructures on 4 implants, allowing for immediate loading when splinted.

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 (K894595, K971578)
• Nobel Biocare Branemark Implants (K925765, K934825)
• Implant Innovations Implants (K954347, K960417)
• Sterngold Implamed Implants (K981516)
• SARGON Dental Implants (K930071)

Submission Summary (Full Text)

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K984104

# ATTACHMENT 8 - 510(k) Summary

### Annlicant's Name and Address 1 .

Straumann USA (on behalf of Institut Straumann AG) Reservoir Place 1601 Trapel › Road Waltham, MA 02451 781-890-0001 Telephone Number: 781-890-6464 Fax Number: Contact Person:

Linda Jalbert, Director of Regulatory Affairs

### 2. Name of the Device

Trade Name: Common Name: Classification Name: ITI Dental Implant System® Dental Implant Endosseous Dental Implant (21 CFR 872,3640)

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

ITI Dental Ir plants (K894595, K971578) Nobel Bioca e Branemark Implants (K925765, K934825) Implant Innovations Implants (K954347, K960417) Sterngold Implamed Implants (K981516) SARGON Dental Implants (K930071)

### 4. Description of the Device

The All-in-O re implants are screw type dental implants made from CP titanium. Grade 4. They are available in various 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.

#### న్న Intended Use of the Device

The ITT All-in-One Dental Implants are intended to be placed in the maxillary and/or mandibular a ch to support prosthetic reconstructions in edentulous or partially edentulous patients.

### ర. Basis for Substantial Equivalence

The modified ITI dental implants are substantially equivalent to ITT Dental Implants, the Nobel Biocare Branemark implants, Sargon 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, Sargon 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 ITT implants in similar to the cleared ITI implants. The implant has a rough surface in contact wit i bone for osseointegration and a smooth titanium surface in contact with mucosa. The design of the modified implants are also similar to the commercially available Nobel Biocare Branemark, Sterngold Implamed, and Implant Innovations implants.

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular emblem with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 3 1999

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

Re : K984104 ITI Dental Implant System® Trade Name: Requlatory Class: ırı Product Code: DZE February 18, 1999 Dated: February 19, 1999 Received:

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 aqainst 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (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 requlation 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 requlation (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
premarket notification" (21 CFR 807.97). 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.fpa.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Tir Director Divishon of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

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Page

K984104 510(k) Number (if known):

| Device Name: | ITI One Part Implant |
|--------------|----------------------|
|--------------|----------------------|

Indications For Use:

ITI One Part octa 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.

ITI one-part octa implants are for use in edentulous jaws in conjunction with barborne superstructure on 4 implants. If ITI one-part implants are splinted with a bar, they can be loaded immediately.

ITI one-part implants can also be used for indications requiring endosseous implants for functional rehabilitation in regions where an ITI two part implant and an Octa abutment would normally be used.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runner

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

(Optional Format 3-10-98)

Prescription Use (Per 21 CFR 801.109)