EVERSTICKNET

K011799 · Stick Tech , Ltd. · EBI · Nov 5, 2001 · Dental

Device Facts

• Record ID: K011799
• Device Name: EVERSTICKNET
• 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 partial and full crowns and bridges. As reinforcement for customized splints used to immobilize teeth which may be required post-trauma, post-operative, or for orthodontic therapy.

Device Story

everStickNet is a semi-manufactured dental reinforcement material consisting of a thin, bi-directionally continuously woven fiberglass fabric impregnated with a polymer/resin matrix. It is used by dental professionals to increase the strength and stiffness of dental acrylic polymers and composite structures. The material is incorporated into the fabrication or repair process of dentures, crowns, bridges, and splints. By providing structural reinforcement, the device enhances the durability and mechanical integrity of the final dental appliance, benefiting the patient by reducing the risk of fracture or failure of the dental restoration or appliance.

Clinical Evidence

Bench testing only.

Technological Characteristics

Material: Bi-directionally continuously woven glass fiber impregnated with polymer/resin matrix. Form factor: Thin fiberglass fabric. Function: Reinforcement for dental acrylic polymers and composites. No electronic components or software.

Indications for Use

Indicated for dental patients requiring reinforcement of full/partial dentures, overdentures, orthodontic appliances, temporary/permanent crowns and bridges, or customized splints for tooth immobilization post-trauma, post-operative, or for 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

• fibreNet (K003334)

Submission Summary (Full Text)

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# NOV 0 5 2001

### F. 510(k) Summary

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

Description of Device:

everStickNet™ is a semi-manufactured product made of glass fibers and polymer/resin matrix for reinforcing dental acrylic polymers. everStickNet™ is made of a thin fiberglass fabric, which increase the strength and stiffness of the final product in all directions.

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 partial and full crowns and bridges.

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

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everStickNet™ is substantially equivalent to fibreNet™, approved under 510(k) number K003334 dated January 8, 2001.

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

everStickNet™ is a polymer impregnated bi-directionally continuously woven glass fiber whereas fibreNet™ is a polymer pre-impregnated bi-directionally woven glass fiber. The different technological characteristics of everStickNet™ 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 everStickNet™ 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 consists of a stylized eagle with three stripes forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Stick Tech Limited NOV 0 5 2001 C/O Dr. William Troetel Managing Partner William M. Troetel, LLC 80 Parkway West Mount Vernon, New York 10552

Re: K011799

Trade/Device Name: Eversticknet Regulation Number: 872.3760 Regulation Name: EBI Resin, Denture, Relining, Repairing, 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 (1 12) is and 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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of the Act or any Federal statutes and regulations administered by other Federal agencies. of the Act of ally I ederal states and Nyanments, including, but not limited to: registration 1 ou must comply with and the reseling (21 CFR Part 801); good manufacturing practice allu listing (21 CFR Pat 807), absitisg (QS) regulation (21 CFR Part 820); and if requirents as set form in are quality in 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 anow you to oegalling of substantial equivalence of your device to 310(k) promative nouricate 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 II you desire specific ad 1.00 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and Office of Collightance are, 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 notification (21 OF ICP of the Division of Small Manufacturers, International and the Act may be obtained in its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

[signature]

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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# B-1

# NOV 0 5 2001

## B. Indications for Use

510(k) Number (if known): \<< \ \ \ ] \ 9 9

Device Name: __everStickNetTM

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

Suvas Rana

Division Sidt Division of Dental, Infection Con and General Hosp F100k) 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) OR

Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)