STRAUMANN EXTRAORAL IMPLANT SYSTEM

K990458 · Straumann USA · KCZ · Apr 16, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K990458
• Device Name: STRAUMANN EXTRAORAL IMPLANT SYSTEM
• Applicant: Straumann USA
• Product Code: KCZ · General, Plastic Surgery
• Decision Date: Apr 16, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3800
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The Straumann Extraoral implant is an endosseous implant intended for placement in the skull, mainly in the mastoid process, periorbital, and perinasal regions. Its purpose is to provide rigid retention for maxillofacial epitheses such as eye, ear and nose epitheses.

Device Story

Solid, threaded, self-tapping titanium (Grade 4) endosseous implant; insertion lengths 2.5 mm to 5.0 mm. Features rough SLA surface for osseointegration in bone and smooth machined surface for epithelial tissue attachment. Used by surgeons for anchoring craniofacial prostheses. Provides mechanical retention for eye, ear, and nose epitheses. Implanted into skull regions to support external prosthetic devices.

Clinical Evidence

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

Technological Characteristics

Material: Titanium, Grade 4. Design: Solid, threaded, self-tapping, 2.5-5.0 mm length. Surface: Rough SLA (bone contact) and smooth machined (soft tissue contact).

Indications for Use

Indicated for patients requiring rigid retention of maxillofacial epitheses (eye, ear, nose) via endosseous implantation in the skull, specifically mastoid, periorbital, and perinasal regions.

Regulatory Classification

Identification

An external aesthetic restoration prosthesis is a device intended to be used to construct an external artificial body structure, such as an ear, breast, or nose. Usually the device is made of silicone rubber and it may be fastened to the body with an external prosthesis adhesive. The device is not intended to be implanted.

Predicate Devices

• ITI SLA Dental Implant (K971578)
• Nobel Biocare (K945154)
• Leibinger Epitec Implant (K961719)
• BUD Craniofacial Implant (K912521)

Submission Summary (Full Text)

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K990408

### APR 16

1 ..

# ATTACHMENT 9 - 510(k) Summary

# Applicant's Name and Address

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: · Extraoral Implant Extra Oral Implant Threaded Metallic Bone Fixation Fastener (21 CFR 888.3040)

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

ITI SLA Dental Implant (K971578) Nobel Biocare (K945154) Leibinger Epitec Implant (K961719) BUD Craniofacial Implant (K912521)

### Description of the Device 4.

Description of the Device
The Extraoral implant is a solid, threaded, self-tapping implant made from 2.5 mm to 5.0 The Extraoral Intplant 15 a solla, n. insertion lengths ranging from 2.5 mm to 5.0
titanium, Grade 4. It is available in insertion lengths ranging from 2.5 mm do 5.0 thanium, Orade 4. It is available in his as cleared Strauman endosseous dental mm. It has the same rough barace as the a smooth machined surface to allow for the attachment of epithelial tissue.

### Intended Use of the Device న.

Intended OSC of the Dories
The Straumann Extraoral implant is an endosseous implant intended for The Straumann Extraord implainthe mastoid process, periorbital, and perinasal
placement in the skull, mainly in the mastoid process, periorbith with and success with placement in the skull, mainly in tigid retention for maxillofacial epitheses such as eye, ear and nose epitheses.

## Basis for Substantial Equivalence

The Straumann Extraoral Implant is substantially equivalent to the Nobel Blocare The Straumann Extraoral Iniptant is Suscements System Implant, the Leibinger Boite Anchored Craniofacial Implant in intended use, material and

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design. In addition, the Extraoral Implant is substantially equivalent to the ITI SLA Dental Implant in material and design.

The Extraoral implant has the same intended use as the Nobel Biocare The Extraofal Implant, the Bud Craniofacial Implant and the Leibinger Epited al Inflant, the Date implants, the Straumann Extraoral implant is Implant. intended to be used for the mechanical retention of a craniofacial prosthesis.

The Extraoral implant is composed of the same material and has the same surface I he Extraoral implant is composed as addition, the design of the Extraoral implant is as the 111 SEA demar implant. In the Bud implants. Like the ITI dental implant, the Extraoral implant has a rough SLA surface in contact with bone for the Extraoral Infplant has a from surface in contact with soft tissue. Like ossebilitegration and a smooth thank, the Straumann Extraoral implants have a the 1000r I topping implanted portion for anchorage in bone.

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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 a stylized symbol that resembles a human figure with three overlapping profiles, representing health and human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 16 999

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

Re : K990458 Straumann Extraoral Implant System Trade Name: Requlatory Class: I Product Code: KCZ February 11, 1999 Dated: Received: February 12, 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, Druq, 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਸ 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 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 the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Jalbert

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 marice 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 che office of Compliance at [phone]. Also, please note ens 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.fda.gov/cdrh/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

Enclosure

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## Indications for Use Statement

### Device Name:

Extraoral Implant

### Indications for Use:

The Straumann Extraoral implant is an endosseous implant intended for placement in the The Strainland Extractorial, and perinasal regions. Its purpose is to purpose is to skun, manny in the may or craniomaxillofacial epitheses such as eye, ear and nose epitheses.

Susan Rurr

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

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