EVERSTICK A&O

K051953 · Stick Tech , Ltd. · DYW · Mar 21, 2006 · Dental

Device Facts

• Record ID: K051953
• Device Name: EVERSTICK A&O
• Applicant: Stick Tech , Ltd.
• Product Code: DYW · Dental
• Decision Date: Mar 21, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5470
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For orthodontic splinting

Device Story

everStick® A&O is a semi-manufactured dental product composed of unidirectional glass fibers and a polymer/resin matrix. It is used by dentists for orthodontic splinting. The device provides increased strength and stiffness perpendicular to the fiber direction. It is applied clinically to stabilize teeth in orthodontic procedures. The device is supplied as a material for professional use, requiring prescription.

Clinical Evidence

No clinical data provided; substantial equivalence is based on clinical usage comparison and material composition analysis.

Technological Characteristics

Semi-manufactured product consisting of unidirectional glass fibers in a polymer/resin matrix. Designed for orthodontic splinting applications.

Indications for Use

Indicated for orthodontic splinting.

Regulatory Classification

Identification

An orthodontic plastic bracket is a plastic device intended to be bonded to a tooth to apply pressure to a tooth from a flexible orthodontic wire to alter its position.

Predicate Devices

• Damon 3 (K052477)

Reference Devices

• everStick® PERIO (K030072)

Submission Summary (Full Text)

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MAR 2 ] 2006

## 510(k) Summary ﻨﺎ

| Applicant: | Stick Tech Ltd, PO Box 114, 20521 Turku, Finland<br>Tel: [phone]<br>Fax: [phone] |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Karri Airola, Ph.D. |
| U.S. Agent to respond to FDA requests: | William M. Troetel, Ph.D.<br>80 Parkway West<br>Mount Vernon, NY 10552<br>Tel: [phone]<br>Fax: [phone]<br>[e-mail] |
| Date Prepared: | January 30, 2006 |
| Device Trade Name: | everStick® A&O |
| Device Common Name: | Glass fiber for orthodontic splinting |
| Device Classificaton Name: | Orthodontic Plastic Bracket<br>(21 CFR §872.5470) |

Description of Device:

everStick® A&O is a semi-manufactured product made of glass fibers and polymer/resin matrix. The glass fiber in everStick® A&O is unidirectional which increases the strength and stiffness of the final product perpendicular to the direction of the fibers.

For orthodontic splinting Intended Use:

everStick A&O is substantially equivalent to its predicate device Damon 3 (510(K) number K052477) by Ormco Inc. in its clinical use. The composition of everStick® A&O is equal to everStick® PERIO (510(k) number K030072). By comparing the clinical usage of everStick A&O with the plastic bracket Damon 3 and by comparing the ingredients of everStick® A&O to the existing data available from dental polymerizable material, it can be stated that everStick® A&O does not expose the dentist nor the patient to unacceptable risks.

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features an eagle-like symbol with three stylized lines representing the bird's body and wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" are arranged in a circular pattern around the eagle symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAK 2 J 2006

Stick Tech Limited C/O Dr. William M. Troetel Certified Regulatory Consultant Managing Partner William M. Troetel, LLC 80 Parkway West Mount Vernon, New York 10552

Rc: K051953

Trade/Device Name: everStick® A&O Regulation Number: 872.5470 Regulation Name: Orthodontic Plastic Brackct Regulatory Class: II Product Code: DYW Dated: March 7, 2006 Received: March 8, 2006

Dear Dr. Troetel:

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 mendments, or to devices that have been reclassified in accordance with the provisions of Amendinens, or to de reast act (Act) that do not require approval of a premarket the Fouchal application (PMA). You may, therefore, market the device, subject to the general approval applicans of the Act. The general controls provisions of the Act include controls provisions of a 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 If your dovice in elabories to such additional controls. Existing major regulations affecting (1 WA), it may ob subject in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device ear or roublish further announcements concerning your device in the Eederal Register.

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## Page 2 - Dr. Troetel

Please be advised that FDA's issuance of a substantial equivalence determination does not I Teast to advisod that 1992 a determination that your device complies with other requirements mean that I Drimas made a atutes and regulations administered by other Federal agencies. of the Act of ally rederal station and securements, including, but not limited to: registration r ou must comply what are 807); labeling (21 CFR Part 801); good manufacturing practice alla listing (21 OF R Par 807), acclity systems (QS) regulation (21 CFR Part 820); and if requirements as set form in are quarty ajon 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) This letter will anon your be FDA finding of substantial equivalence of your device to a prematics notification. - 11 cevice 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), rryou dealte splee 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 may volum 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.

Clur

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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## Indications for Use Statement B.

510(k) Number (if known):_K ﮏ۱۹ﮐ >

Device Name: everStick® A&O

Indications for Use:

- . For orthodontic splinting
Susan Cuomo

v, General Hospit

K031953

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANQTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X (Per 21 CFR 801.109) OR

Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)