ORTHO IMPLANT AND ACCESSORIES

K982509 · Straumann USA · OAT · Sep 30, 1998 · Dental

Device Facts

• Record ID: K982509
• Device Name: ORTHO IMPLANT AND ACCESSORIES
• Applicant: Straumann USA
• Product Code: OAT · Dental
• Decision Date: Sep 30, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Ortho implant of the Straumann Orthosystem is an endosseous implant intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed.

Device Story

Ortho implant is solid, one-piece, threaded, self-tapping dental implant; CP titanium Grade 4 construction; 4.0 mm or 6.0 mm lengths. Features rough surface for osseointegration in bone and smooth machined surface for transmucosal tissue attachment; coronal portion internally threaded with hex head. Used by orthodontists/dentists in clinical setting to provide fixed anchorage for orthodontic appliances; facilitates tooth movement. Implant is temporary; removed upon treatment completion. Benefits patient by providing stable anchorage point for complex orthodontic corrections.

Clinical Evidence

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

Technological Characteristics

Material: CP titanium, Grade 4. Design: Solid, one-piece, threaded, self-tapping. Surface: Rough (osseointegration) and smooth (transmucosal). Dimensions: 4.0 mm and 6.0 mm lengths. Configuration: Internally threaded coronal portion with hex head. Energy source: None (mechanical).

Indications for Use

Indicated for patients requiring orthodontic tooth movement; implant placement in median palatal region or retromolar positions to provide fixed anchorage for orthodontic appliances; temporary use only, removed post-treatment.

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 SLA Dental Implant with Bonding Base (K971578, K973353)
• Nobel Biocare Onplant (K980460)
• Sendax Mini Dental Implant (K972351)

Submission Summary (Full Text)

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# ATTACHMENT 9 - 510(k) Summary

### 1. Applicant's Name and Address

Straumann USA (on behalf of Institut Straumann AG) Reservoir Place 1601 Trapelo Road Waltham, MA 02154 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: Ortho Implant Orthodontic Implant Dental Implant (21 CFR 872.3640)

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

ITI SLA Dental Implant with Bonding Base (K971578, K973353) Nobel Biocare Onplant (K980460) Sendax Mini Dental Implant (K972351)

### 4. Description of the Device

The Ortho implant is a solid one-piece, threaded, self-tapping design made from CP titanium, Grade 4. It is available in insertion lengths of 4.0 mm and 6.0 mm. It has the same rough surface as cleared Straumann endosseous implants. The transmucosal part 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.

### 5. Intended Use of the Device

The Ortho implant of the Straumann Orthosystem is an endosseous implant intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed.

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### Basis for Substantial Equivalence റ.

The Ortho implant is substantially equivalent to ITI SLA Dental Implant with Bonding Base, the Nobel Biocare Onplant, and the Sendax Mini Dental Implant in intended use, material and design.

The Ortho implant has the same intended use as the Straumann bonding base used in combination with an ITI dental implant and the Nobel Biocare Onplant. Like the Onplant and the Sendax Mini Dental Implant, the Ortho implant is intended to be used as a temporary implant.

The Ortho implant is composed of the same material and has the same surface as the ITI SLA dental implant. In addition, the design of the Ortho implant is similar to the Nobel Biocare Onplant. The implant has a rough surface in contact with bone for osseointegration and a smooth titanium surface in contact with mucosa. Both implants have a threaded transmucosal portion for attachment of the orthodontic anchorage appliance.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & 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 image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 2 2007

Ms. Linda Jalbert Director, Regulatory Affairs Straumann USA Reservoir Place 1601 Trapelo Road Waltham, Massachusetts 02145

Re: K982509

Trade/Device Name: Ortho Implant and Accessories Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous dental implant Regulatory Class: II Product Code: OAT Dated: July 17, 1998 Received: July 20, 1998

Dear Ms. Jalbert:

This letter corrects our substantially equivalent letter of September 30, 1998.

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. Jalbert

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,

Suite of Michael Omd

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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510(k) Number (if known): K902509

Device Name:

Indications For Use:

The Ortho implant of the Straumann Orthosystem is an endosseous implant intended for placement in the median palatal region or in retromolar positions. lts 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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96).