ESTHETIC EASE ABUTMENTS FOR THE ITI DENTAL IMPLANT SYSTEM

K020096 · Institut Straumann AG · DZE · Feb 8, 2002 · Dental

Device Facts

• Record ID: K020096
• Device Name: ESTHETIC EASE ABUTMENTS FOR THE ITI DENTAL IMPLANT SYSTEM
• Applicant: Institut Straumann AG
• Product Code: DZE · Dental
• Decision Date: Feb 8, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.3640
• Device Class: Class 2

Intended Use

Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns or bridges. The ITI Esthetic abutments are indicated for cemented restorations in esthetic areas of the mouth. The abutment can be used to restore crowns for single tooth replacements and bridges for multiple tooth restorations.

Device Story

ITI Esthetic Abutments are dental implant components designed to support prosthetic reconstructions; placed into dental implants to provide foundation for cemented crowns or bridges. Device consists of abutment body and titanium alloy screw; features conical taper with inset octagonal design. Available in 4.8 mm and 6.5 mm diameters. Used by dental professionals in clinical settings to restore single tooth replacements or multiple tooth bridges. Abutment is mounted into implant shoulder; provides structural support for final prosthetic restoration. Benefits include improved esthetic outcomes for patients requiring dental reconstruction.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Material: Commercially pure Grade 4 titanium (ASTM F67) with titanium alloy screw. Design: Conical taper with inset octagonal geometry. Diameters: 4.8 mm and 6.5 mm. Mechanical fixation via screw. Non-software device.

Indications for Use

Indicated for patients requiring cemented dental restorations, including single crowns or bridges, in esthetic areas of the mouth.

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 synOcta Abutment (K990342)
• ITI Wide Neck Implant synOcta Abutment (K013798)

Submission Summary (Full Text)

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# KO20096

## FEB 0 8 2002

### 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: Contact Person: Linda Jalbert Director, Requlatory Affairs

#### 2. Name of the Device

| Trade Name: | ITI Esthetic Ease Abutments |
|----------------------|-----------------------------------------------|
| Common Name: | Dental implant abutment |
| Classification Name: | Endosseous dental implants<br>21 CFR 872.3640 |

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

ITI synOcta Abutment (K990342) ITI Wide Neck Implant synOcta Abutment (K013798)

#### Description of the Device 4.

The ITI Dental Implant System is an integrated system of endosseous dental implants which are designed to support prosthetic devices for partially or fully edentulous patients. The system consists of a variety of dental implants, abutments, and surgical and prosthetic parts and instruments. The devices covered by this submission are abutments which are placed into the dental implant to provide support for a prosthetic reconstruction. The subject abutments are indicated for cemented restorations, particularly in esthetic areas of the mouth.

The ITI esthetic abutments are made from commercially pure Grade 4 titanium (ASTM F67) with a titanium alloy screw. The basal portion of the abutment has conical taper with an inset octagonal design. The abutment is placed over the implant shoulder and is mounted into the implant with a

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screw. The abutment is available in two diameters for use with ITI implants with shoulder diameters of 4.8 mm and 6.5 mm.

#### Intended Use of the Device 5.

The devices covered by this submission are abutments which are placed into the dental implant to provide support for a prosthetic reconstruction. The subject abutments are indicated for cemented restorations, particularly in esthetic areas of the mouth. The abutment can be used to restore crowns for single tooth replacements and bridges for multiple tooth restorations.

#### 6. Basis for Substantial Equivalence

The ITI esthetic abutments are substantially equivalent in intended use, material, and design to the ITI synOcta abutments cleared under K990342and ITI Wide Neck Implant synOcta abutments cleared under K013798.

ITI synOcta Esthetic Abutments 01/10/02 Page 23 of 26

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and 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 in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 0 8 2002

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

Re: K020096

Trade/Device Name: ITI Esthetic Abutments Regulation Number: 872.3640 Regulation Name: Dental Implant System Regulatory Class: III Product Code: DZE Dated: January 9, 2002 Received: January 11, 2002

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.

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

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### Page 2 - Ms. Jalbert

of the Act or any Federal statutes and regulations administered by other Federal agencies. or the Act of ally I outsial title Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and instills (21 es read in the quality systems (QS) regulation (21 CFR Part 820); and if requirence 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 11ms letter will and w your of your 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 If you desire pp. 11 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Timothy A . Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

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510(k) Number (if known):

Device Name: ITI Esthetic Abutments

Indications For Use:

Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns or bridges. The ITI Esthetic abutments are indicated for cemented restorations in esthetic areas of the mouth. The abutment can be used to restore crowns for single tooth replacements and bridges for multiple tooth restorations.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_ (Per 21 CFR 801.109) OR

Over-The-Counter Use

(Optional Format 1-2-96)

R. A. Ulatra A.

Division Sign-Off) ് vision of Dental, Infection Control, ം General Hospital Devices 110(k) Number ________________________________________________________________________________________________________________________________________________________________

ITI synOcta Esthetic Abutments 01/10/02 Page 26 of 26