EVERSTICK ORTHO

K021126 · Stick Tech , Ltd. · EBI · May 13, 2002 · Dental

Device Facts

• Record ID: K021126
• Device Name: EVERSTICK ORTHO
• Applicant: Stick Tech , Ltd.
• Product Code: EBI · Dental
• Decision Date: May 13, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3760
• Device Class: Class 2

Intended Use

GLASS-FIBER REINFORCEMENT FOR ORTH-DONTIC RETAINERS

Device Story

everStick ORTHO is a semi-manufactured dental material composed of unidirectional glass fibers and a polymer/resin matrix. It is used by dental professionals as a reinforcement component for orthodontic retainers. The device provides increased strength and stiffness in the direction perpendicular to the fibers. It is applied by the clinician to stabilize teeth following orthodontic treatment. The device is supplied as a semi-manufactured product that is integrated into the final retainer structure by the dentist.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on comparison of ingredients and existing data available for dental polymerizable materials, concluding no unacceptable risks to the dentist or patient.

Technological Characteristics

Semi-manufactured material consisting of unidirectional glass fibers and polymer/resin matrix. Dimensions and specific ASTM standards are not provided. The device is a passive dental material; no energy source, connectivity, or software components are involved.

Indications for Use

Indicated for use as a glass-fiber reinforcement for orthodontic retainers.

Regulatory Classification

Identification

A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.

Predicate Devices

• everStick (K011788)

Submission Summary (Full Text)

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## 510(k) Summary u

Stick Tech Ltd, PO Box 114, 20521 Turku, Finland Applicant: Tel: [phone] Fax: [phone] Ilkka Kangasniemi, Ph.D. Contact Person: William M. Troetel, Ph.D. U.S. Agent to respond to 80 Parkway West FDA requests: Mount Vernon, NY 10552 Tel: [phone] Fax: [phone] [e-mail] April 4, 2002 Date Prepared: everStick™ ORTHO Device Trade Name: Device Common Name: Glass fiber orthodontic retainer Denture relining, repairing, or rebasing resin Device Classificaton Name: (21 CFR §872.3760)

Description of Device:

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

Intended Use: As orthodontic retainer

everStick™ ORTHO is substantially equivalent to everStick™, approved under 510(k) number K011788 dated November 7, 2001.

The composition of everStick™ ORTHO is equal with its predicate device, everStick™. Only the ratio of glass fibers and polymer matrices are slightly different. The indication for use in orthodontics supplements the indications for use to be done with the predicate device.

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By comparing the ingredients of everStick ORTHO to the existing data available from dental polymerizable material, it can be stated that everStick ORTHO does not expose the dentist nor the patient to unacceptable risks.

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Public Health Service

MAY 13 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Stick Tech. Limited C/O William M. Troetel, Ph.D., LLC 80 Parkway West Mount Vernon, New York 10552

Re: K021126

Trade/Device Name: everStick™ ORTHO Regulation Number: 872.3760 Regulation Name: Denture Relining, Repairing, or Rebasing Resin Regulatory Class: II Product Codes: EBI and DYT Dated: April 05, 2002 Received: April 08, 2002

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 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 appeared were in 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 (1 ra )) var 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.

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.

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## Page 2 - Dr. William M. Troetel

You must comply with all the Act's requirements, including, but not limited to: registration r ou must compry was and many (21 CFR Part 801); good manufacturing practice and ilsung (21 CF R Part 801), and ity systems (QS) regulation (21 CFR Part 820); and if requirents as bet rent in aroduct 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 1111s letter will and in yours of the FDA finding of substantial equivalence of your device to 910(x) promation nowledge 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 11 you debire up 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the and catalians in onal [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Valter Cussatfor

Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

| Page | 1 of 1 |
|---------------------------|------------------|
| 510(k) Number (if known): | K021126 |
| Device Name: | EVER STICK ORTHO |

Indications for Use:

GLASS-FIBER REINFORCEMENT FOR
ORTH-DONTIC RETAINERS

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

Susan Runnes

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

Prescription Use (Per 21 CFR 801.108) OR

Over the Counter Use _