ORTHODONTIC TAADS (TEMPORARY ANATOMICAL ANCHOR DEVICE SYSTEM)

K063149 · T.O.A.D.S., LLC · OAT · Mar 8, 2007 · Dental

Device Facts

• Record ID: K063149
• Device Name: ORTHODONTIC TAADS (TEMPORARY ANATOMICAL ANCHOR DEVICE SYSTEM)
• Applicant: T.O.A.D.S., LLC
• Product Code: OAT · Dental
• Decision Date: Mar 8, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Orthodontic TAADS Screws are intended to provide a fixed anchorage point for the attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. They are intended for temporary use and should be removed after orthodontic treatment has been completed. The screws are intended for single use only.

Device Story

Orthodontic TAADS (Temporary Anatomical Anchor Device System) consists of single-use, screw-type, root-form endosseous dental implants. Designed for anchoring orthodontic appliances to the jaw to facilitate tooth movement. Each model is region-specific for optimal holding power and anodized for color-coded identification. Provided in sterile and non-sterile versions. Used by orthodontists in a clinical setting. The device provides a stable, fixed point for appliance attachment, allowing for controlled orthodontic force application. Benefits include temporary, removable anchorage that is removed upon completion of treatment.

Clinical Evidence

No clinical data. Substantial equivalence determined via dimensional comparison and engineering analysis (bench testing only).

Technological Characteristics

Screw-type, root-form endosseous dental implants. Anodized for identification. Single-use. Provided in sterile and non-sterile configurations. Mechanical fixation principle.

Indications for Use

Indicated for patients requiring fixed anchorage for orthodontic appliances to facilitate tooth movement. Intended for temporary use; must be removed post-treatment. Single-use only.

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

• AbsoAnchor (Orthodontic Microimplant) (K060126)
• Lin/Liou Orthodontic Mini Anchor System (LOMAS) (Sterile) (K050257)
• Temporary Orthodontic Anchor (K061266)
• tomas (Temporary Orthodontic Micro Anchorage System) pins (K042965)

Submission Summary (Full Text)

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## 3. 510(K) SUMMARY T.O.A.D.S., LLC. 1. Applicant/Sponsor. 1226 Rowan St. Louisville, KY 40203 MAR 0 8 2007 David Baughman 2. Contact Person: President Email: [e-mail] Phone: [phone]. Proprietary Name: Orthodontic TAADS (Temporary Anatomical Anchor Device System) 4. Common Name: Screw type endosseous implants 5. Classification Name: Endosseous Implant (21 CFR 872.3640) ర. Legally Marketed Devices to which Substantial Equivalence is claimed: AbsoAnchor (Orthodontic Microimplant) - Dentos Incorporated (K060126) a. b. Lin/Liou Orthodontic Mini Anchor System (LOMAS) (Sterile) - Mondeal Medical Systems GmbH (K050257) Temporary Orthodontic Anchor - Ortho Organizers, Inc. (K061266) C. tomas (Temporary Orthodontic Micro Anchorage System) pins - Dentaurum ರ್ಕರ (K042965) 7. Device Description: The Orthodontic TAADS Screws are single-use, screw-type, root-form endosseous dental implants designed for the anchoring of orthodontic appliances to the jaw. Each Orthodontic TAADS Screw model is designed for optimal holding power and function in a specific region of the mouth or jaw. Each model is also anodized for ease of identification through color. All of the TAADS devices are intended for

and non-sterile versions.

immediate loading. All of the Orthodontic TAADS Screws are provided in sterile

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- 8. Intended Use:
The Orthodontic TAADS Screws are intended to provide a fixed anchorage point for the attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. They are intended for temporary use and should be removed after orthodontic treatment has been completed. The screws are intended for single use only.

- 9. Summary of Technologies/Substantial Equivalence:
The Orthodontic TAADS Screws have the same intended use and indications for use as, consist of the same materials as, and are similar in design to the following predicate devices: AbsoAnchor (Orthodontic Microimplant) - Dentos Incorporated; and Lin/Liou Orthodontic Mini Anchor System (LOMAS) (Sterile) - Mondeal. They are also similar in design and function to the Temporary Orthodontic Anchor -- Ortho Organizers, Inc. and the tomas (Temporary Orthodontic Micro Anchorage System) pins - Dentaurum. Each of the Orthodontic TAADS Screw devices passes previously defined performance requirements and is thus considered to be as functionally safe and effective as the predicate devices.

- 10. Non-Clinical Testing:
Dimensional comparison and engineering analysis were used to determine that the Orthodontic TAADS Screws are substantially equivalent to the predicate devices. Non-clinical (bench) testing was not performed.

- 11. Clinical Testing:
Clinical testing was not necessary to determine substantial equivalence between the Orthodontic TAADS Screws and the predicates.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an abstract eagle design with three stylized wing segments. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. David Baughman President T.O.A.D.S., LLC 1226 Rowan Street Louisville, Kentucky 40203

MAR 0 8 2007

Re: K063149

Trade/Device Name: Orthodontic TAADS (Temporary Anatomical Anchor Device System) Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: OAT Dated: February 16, 2007 Received: February 20, 2007

Dear Mr. Baughman:

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 – Mr. Baughman

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,

Cluts

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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## 2002. FINDICATIONS FOR USE I

510(k) Number (if known): _

Device Name: Orthodontic TAADS (Temporary Anatomical Anchor Device System)

Indications for Use:

The Orthodontic TAADS Screws are intended to provide a fixed anchorage point for the attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. They are intended for temporary use and should be removed after orthodontic treatment has been completed. The screws are intended for single use only.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

*Suse Cousine*

Division of Anesthesiology, General Hospital,

Infection Control, Div. Services

| 510(k) Number: | k06319 |
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