ABSOANCHOR MICROIMPLANT

K060126 · Dentos, Inc. · DZE · May 16, 2006 · Dental

Device Facts

• Record ID: K060126
• Device Name: ABSOANCHOR MICROIMPLANT
• Applicant: Dentos, Inc.
• Product Code: DZE · Dental
• Decision Date: May 16, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

To provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth

Device Story

AbsoAnchor is an endosseous dental microimplant used in orthodontics to provide fixed anchorage for tooth movement. Device consists of a titanium alloy (ASTM F136) screw with various head styles (button, bracket, etc.) and neck designs to reduce gingival impingement. Available in taper or cylinder forms with diameters of 1.2mm–1.8mm. Inserted into maxilla or mandible between tooth roots by a dental professional. Head features accept ligatures, coil springs, or elastomers. Provides stable point for applying orthodontic forces; facilitates tooth movement; benefits patient by enabling complex orthodontic corrections.

Clinical Evidence

No clinical data. Substantial equivalence is based on bench testing and comparison of technological characteristics to legally marketed predicate devices.

Technological Characteristics

Material: Titanium-6Aluminum-4Vanadium ELI Alloy Grade 5 (ASTM F136). Form: Endosseous screw, 1.2mm-1.8mm diameter, 4.0mm-12mm length. Head styles: 8 variations (e.g., bracket, button, OMAS mushroom). Sterilization: Non-sterile, requires steam sterilization by user. Mechanical fixation via screw threads.

Indications for Use

Indicated for patients requiring orthodontic tooth movement who need a fixed anchorage point for the attachment of orthodontic appliances.

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

• Dentaurum Tomas-pin (K042965)
• Jeil Medical Dual Top Anchor System Screws (K033767)
• IMTEC MDI Ortho (K042289)

Submission Summary (Full Text)

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K060126

## Dentos, Incorporated Dong Bu B/D 2F #22, 251,4Ga, Dong-In-Dong Jung-Gu Daugu, South Korea, 700-424 Phone: [phone] Fax: [phone] Contact: Myung Sub Kim, Assistant Manager of Quality Management Summary Preparation Date: 10/25/05

## 510(k) Summary of Safety and Effectiveness

- 1. Identification of the Device: Proprietary-Trade Name: AbsoAnchor (Orthodontic Microimplant) Classification Name: Implant, Endosseous, Product Code DZE Common/Usual Name: Dental Implant
- 2. Equivalent Legally Marketed Devices: Dentaurum Tomas-pin (K042965), Jeil Medical Dual Top Anchor System Screws (K033767), and IMTEC MDI Ortho (K042289).
- 3. Description of the Device:

The Dentos AbsoAnchor Orthodontic Microimplant is composed of Titanium-6Aluminum-4Vanadium ELI Alloy Grade 5 (ASTM F136) material. It has been designed specifically for orthodontic use and has a button-like head and a bracket-like head with a small hole that accepts ligatures, coil springs, and elastomers. Gingival impingement by these attachments is reduced due to the slanted neck of the implant head. The smaller diameter of AbsoAnchor (1.2mm - 1.8mm) allows its insertion into many areas of the maxilla and mandible and between roots of adjacent teeth. It is classified into 2 implant groups: Taper and Cylinder. It also consists of 8 different head styles: small head, no head, long head, circle head, fixation head, bracket head, bracket head-left handed screw, OMAS mushroom.

- 4. Indications for Use:
To provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth

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- 5. Potential Adverse Affects and Complications (common to all devices of this type):
- Metal sensitivity or allergic reaction
- Pain or discomfort due to presence of device
- · Infection
- 6. Safety and Effectiveness, Comparisons to Predicate Devices:

| Device<br>Name | AbsoAnchor | Tomas-pin | Dual Top<br>Anchor<br>System | MDI Ortho |
|-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product<br>Code | DZE | DZE | DZE | DZE |
| Applicant | Dentos, Inc | Dentaurum,<br>Inc | Jeil<br>Medical<br>Corp. | IMTEC Corp. |
| 510(k) # | This submission | K042965 | K033767 | K042289 |
| Material | Titanium6Aluminum-<br>4Vanadium ELI<br>Alloy Grade 5<br>(ASTM F136-98) | Titanium<br>Grade 5 | Titanium<br>Alloy<br>(ASTM<br>F136-98) | Titanium Alloy |
| Intended<br>Use | Provide a fixed<br>anchorage point for<br>attachment of<br>orthodontic<br>appliances to<br>facilitate the<br>orthodontic<br>movement of teeth | Provide a<br>fixed<br>anchorage<br>point for<br>attachment<br>of<br>orthodontic<br>appliances<br>to facilitate<br>the<br>orthodontic<br>movement<br>of teeth | Provide a<br>fixed<br>anchorage<br>point for<br>attachment<br>of<br>orthodontic<br>appliances<br>to facilitate<br>the<br>orthodontic<br>movement<br>of teeth | Provide a<br>fixed<br>anchorage<br>point for<br>attachment of<br>orthodontic<br>appliances to<br>facilitate the<br>orthodontic<br>movement of<br>teeth |
| Sterility | Non-sterile: steam<br>sterilize before use | Sterile | Non-sterile<br>steam<br>sterilize<br>before use | Sterile |
| Diameter | 1.2mm-1.8mm | 1.2mm | 1.4mm-<br>2.0mm | 1.8mm |
| Length | 4.0mm-10mm<br>&12mm | 8.0-10mm | 6.0mm-<br>12mm | 6.0mm,8.0mm<br>& 10mm |

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Image /page/2/Picture/1 description: The image is a black and white emblem for the U.S. Department of Health and Human Services. The emblem features a stylized eagle with three horizontal lines representing its wings. The eagle is enclosed within a circular border, with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" arranged around the upper half of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 16 2006

Dentos, Incorporated C/O Ms. Anna Shafto, BS, MT Health Science Research Assistant University of Michigan School of Dentistry 1011 North University Avenue Ann Arbor, Michigan 48109

Re: K060126

Trade/Device Name: AbsoAnchor Microimplant Regulation Number: 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: April 28, 2006 Received: May 1, 2006

Dear Ms. Shafto:

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.

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## Page 2 - Ms. Shafto

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 begin 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 [phone]. 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/industry/support/index.html.

Sincerely yours,

Svette y. Michau MD

Chiu Lin, Ph.D. 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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K060126

## Indications for Use Statement

510(k) Number (if known): ______________________________________________________________________

Device Name: AbsoAnchor Microimplant

Indications for Use:

The intended purpose of the AbsoAnchor microimplant is to provide a fixed The intendod purpose of thodontic appliances to facilitate the orthodontic movement of teeth.

Prescription Use *X* AND/OR Over-The-Counter Use **__**
(Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runne

11 - 13- 11- 6 : 5) m of Anasthesialogy, General Hospital, on Control, Dantal Devices

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