THE STRAUMANN ORTHO IMPLANT SYSTEM

K040469 · The Straumann Co. · OAT · Apr 30, 2004 · Dental

Device Facts

• Record ID: K040469
• Device Name: THE STRAUMANN ORTHO IMPLANT SYSTEM
• Applicant: The Straumann Co.
• Product Code: OAT · Dental
• Decision Date: Apr 30, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Ortho implant of the Straumann Ortho system is an endosseous implant intended for placement in the mid-sagittal or paramedian area of the hard palate or in retromolar positions. Its purpose is to provide a fixed anchorage point for attachment of orthodontic appliances intended to facilitate the orthodontic movement of teeth. It is used temporarily and is intended to be removed after orthodontic treatment has been completed. Ortho implants can be used in adults and juveniles (age 12 and older). In case of patients who have not yet completed skeletal growth (e.g. as shown by radiographic analysis of the hand/wrist), the ortho implant should be placed off the mid-line in the paramedian region of the palate in order to avoid the midpalatal suture.

Device Story

Solid, one-piece, threaded, self-tapping endosseous dental implant; CP Grade 4 titanium construction; SLA (sand-blasted, acid-etched) rough surface on endosseous portion; smooth machined surface on transmucosal section; internally threaded coronal portion with hex head. Used as temporary fixed anchorage point for orthodontic appliances to facilitate tooth movement. Placed in hard palate or retromolar positions by dental professionals. Removed upon completion of orthodontic treatment. Benefits include stable, temporary skeletal anchorage for complex orthodontic cases.

Clinical Evidence

No clinical data provided; substantial equivalence based on identical design and material characteristics to the predicate device.

Technological Characteristics

Material: CP Grade 4 titanium. Design: Solid, one-piece, threaded, self-tapping. Surface: SLA (sand-blasted, acid-etched) on endosseous portion; smooth machined on transmucosal portion. Coronal: Internally threaded with hex head.

Indications for Use

Indicated for adults and juveniles (age 12+) requiring temporary orthodontic anchorage. Implant placement sites include mid-sagittal/paramedian hard palate or retromolar regions. For patients with incomplete skeletal growth, placement must be in the paramedian region to avoid the midpalatal suture.

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

• Straumann Ortho System (K982509)

Submission Summary (Full Text)

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K04 0469

## ATTACHMENT 8

## 510(k) Summary

### Applicant's Name and Address 1 .

Straumann USA (on behalf of Institut Straumann AG) Reservoir Place 1601 Trapelo Road Waltham, MA 024511 Telephone Number: 781-890-000 1 Fax Number: 781-890-6464 Contact Person: Carolyn Bitetti Associate Director, Regulatory Affairs

#### 2. Name of the Device

Trade Name: Common Name: Classification Name: Straumann Ortho implant Endosseous dental implants Endosseous dental implants 21 CFR 872.3640

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

Straumann Ortho System (K982509)

### র্ব . Description of the Device

The Ortho implant is a solid, one-piece, threaded, self-tapping design made from CP Grade 4 titanium. It has a sand-blasted, acid etched (SLA) rough surface on the endossous portion of the implant. The transmucosal section of the implant has a smooth machined surface to allow for the attachment of epithelial tissue. The coronal portion of the implant is internally threaded and has a hex head.

- Indications for Use 5.
CONFIDENTIAL 510(k) Straumann Ortho Implant Page 33 February 17, 2004

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The Ortho implant of the Straumann Ortho system is an endosseous implant intended for placement in the mid-sagittal area of the hard palate or in retromolar positions. Its purpose is to provide a fixed anchorage point for attachment of orthodontic appliances intended to facilitate the orthodontic movement of teeth. It is used temporarily and is intended to be removed after orthodontic treatment has been completed.

### Basis for Substantial Equivalence 6.

The subject Ortho implants are substantially equivalent in intended use to the currently marketed Straumann Ortho implants.

The subject Straumann Ortho implants have the same design as the previously cleared Straumann Ortho implants. There has been no change in material, surface treatment, design, or operating principle.

CONFIDENTIAL 510(k) Straumann Ortho Implant Page 34 February 17, 2004

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized eagle or bird in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 2 2007

Ms. Carolyn Bitetti Associate Director, Regulatory Affairs The Straumann Company Reservoir Place 1601 Trapelo Road Waltham, Massachusetts 02451

Re: K040469

Trade/Device Name: The Straumann Ortho Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous dental implant Regulatory Class: II Product Code: OAT Dated: February 20, 2004 Received: February 24, 2004

Dear Ms. Bitetti:

This letter corrects our substantially equivalent letter of April 30, 2004.

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 (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 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.

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Page 2 - Ms. Bitetti

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 continue 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 (240) 276-__(see http://www.fda.gov/cdrh/organiz.html#OC for OC organization structure). 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,

Sutte y. Mchier Cus

Chiu S. Lin. PhD 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

K040469 510(k) Number (K982509):

Device Name: Straumann Ortho Implant

Indications for Use:

The Ortho implant of the Straumann Ortho system is an endosseous implant intended for placement in the mid-sagittal or paramedian area of the hard palate or in retromolar positions. Its purpose is to provide a fixed anchorage point for attachment of orthodontic appliances intended to facilitate the orthodontic movement of teeth. It is used temporarily and is intended to be removed after orthodontic treatment has been completed.

Ortho implants can be used in adults and juveniles (age 12 and older). In case of patients who have not yet completed skeletal growth (e.g. as shown by radiographic analysis of the hand/wrist), the ortho implant should be placed off the mid-line in the paramedian region of the palate in order to avoid the midpalatal suture.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Robert Betz, DNSL, & Susan Runner
Page 1 of 1

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

CONFIDENTIAL 510(k) Straumann Ortho Implang10(k) Number:
510(k) Straumann Ortho Implang10(k) Number:
Bago 38 Page 38 February 17, 2004

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