EVERSTICK

K011788 · Stick Tech , Ltd. · EBI · Nov 5, 2001 · Dental

Device Facts

• Record ID: K011788
• Device Name: EVERSTICK
• Applicant: Stick Tech , Ltd.
• Product Code: EBI · Dental
• Decision Date: Nov 5, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3760
• Device Class: Class 2

Intended Use

As reinforcement in manufacturing and/or repairing full or partial dentures as well as overdentures and orthodontic appliances. As reinforcement for temporary and/or permanent plastic/composite inlays, onlays and bridges. As reinforcement for customized splints used to immobilize teeth which may be required for post-trauma, post-operative, or for orthodontic therapy.

Device Story

everStick is a semi-manufactured dental reinforcement material; composed of unidirectional continuous glass fibers impregnated with a polymer/resin matrix. Used by dental professionals in clinical settings to increase strength and stiffness of dental acrylic polymers and composites. Applied during fabrication or repair of dentures, bridges, inlays, onlays, and splints. Provides structural reinforcement to dental appliances; improves durability and mechanical performance of final restorations. No complex electronics or software involved.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Unidirectional continuous glass fibers impregnated with polymer/resin matrix. Form factor: semi-manufactured reinforcement material. No energy source, connectivity, or software.

Indications for Use

Indicated for use as reinforcement in the manufacturing or repair of full/partial dentures, overdentures, orthodontic appliances, temporary/permanent plastic/composite inlays, onlays, bridges, and customized splints for tooth immobilization following trauma, surgery, or orthodontic therapy.

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

• fibreStick (K003333)

Submission Summary (Full Text)

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NOV 0 5 2001

# 510(k) Summary E.

| Applicant: | Stick Tech Ltd, PO Box 114, 20521 Turku, Finland<br>Tel: [phone]<br>Fax: [phone] |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Ilkka Kangasniemi, Ph.D. |
| U.S. Agent to respond to<br>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: | June 4th, 2001 |
| Device Trade Name: | everStickTM |
| Device Common Name: | Glass fiber reinforcement material |
| Device Classification Name: | Denture relining, repairing, or rebasing resin<br>(21 CFR §872.3760) |

Description of Device:

everStick™ is a semi-manufactured product made of glass fibers and polymer/resin matrix for reinforcing dental acrylic polymers. everStick™ is made of unidirectional fibers which increase the strength and stiffness of the final product perpendicular to the direction of the fibers.

Intended Use:

As reinforcement in manufacturing and/or repairing full or partial dentures as well as overdentures and orthodontic appliances.

As reinforcement for temporary and/or permanent plastic/composite inlays, onlays and bridges.

As reinforcement for customized splints used to immobilize teeth which may be required for post-trauma, post-operative, or for orthodontic therapy.

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everStick™ is substantially equivalent to fibreStick™, approved under 510(k) number K003333 dated January 4, 2001.

Testing which has been performed on everStick™ indicates that the device has the same intended use but somewhat different technological characteristics.

everStick™ is a polymer/resin impregnated unidirectional continuous glass fiber whereas fibreStick™ is a polymer pre-impregnated unidirectional continuous glass fiber. The different technological characteristics of everStick™ does not raise new questions of safety and effectiveness and demonstrates that the device is as safe and effective as the predicate device.

Test results indicate that there are no hazards presented with the use of everStick™ as compared with the predicate device.

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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 features a stylized eagle with three lines representing its body and wings. The eagle is facing left and is enclosed in a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 0 5 2001

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

Re: K011788

Trade/Device Name: Everstick Regulation Number: 872.3760 Regulation Name: EBI Resin, Denture, Relining, Pepairing, Rebasing Regulatory Class: II Product Code: EBI Dated: October 29, 2001 Received: October 30, 2001

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 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.

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

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# Page 2 - Dr. Troetel

of the Act or any Federal statutes and regulations administered by other Federal agencies. or the Fet of all - 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 and insting (21 es read of 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [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" (21CFR 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,

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

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# NOV 0 5 2001

# B-1

## B. Indications for Use

510(k) Number (if known): KOLL788

Device Name: __everStick™

Indications for Use:

- As reinforcement in manufacturing and/or repairing full or partial dentures as ● well as overdentures and orthodontic appliances.
- As reinforcement for temporary and/or permanent plastic/composite inlays, . onlays and bridges.
- As reinforcement for customized splints used to immobilize teeth which may . be required post-trauma, post-operative, or for orthodontic therapy.

Susan Punney

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

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

Prescription Use X (Per 21 CFR 801.109)

Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________ OR

(Optional Format 1-2-96)