STICK FLOW

K031341 · Stick Tech , Ltd. · EBF · Oct 29, 2003 · Dental

Device Facts

• Record ID: K031341
• Device Name: STICK FLOW
• Applicant: Stick Tech , Ltd.
• Product Code: EBF · Dental
• Decision Date: Oct 29, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

A flowable light cure microhybrid composite for tooth filling, sealing and cementing.

Device Story

Stick™ Flow is a flowable, light-cured microhybrid composite resin used by dentists for tooth filling, sealing, and cementing. The material is applied to the tooth structure and cured using a dental light source. It provides aesthetic, abrasion-resistant, radiopaque, and high-gloss polishable restorations for anterior and limited posterior applications. The device is intended for professional use in a clinical dental setting.

Clinical Evidence

Bench testing only.

Technological Characteristics

Flowable light-cure microhybrid composite resin. Features include color stability, abrasion resistance, radiopacity, and polishability. Classified as a tooth shade resin material (21 CFR 872.3690).

Indications for Use

Indicated for tooth filling, sealing, and cementing in dental patients requiring anterior and limited posterior restorations.

Regulatory Classification

Identification

Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.

Predicate Devices

• Aeliteflo™ (K955292)

Submission Summary (Full Text)

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K031341

OCT 2 9 2003

## E. 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: | April 16th, 2003 |
| Device Trade Name: | Stick™ Flow |
| Device Common Name: | Flowable light cure composite |
| Device Classification Name: | Material, tooth shade and resin |
| | (21 CFR §872.3690) |

Description of Device:

Stick™ Flow is a flowable composite with excellent color stability. It is flowable, aesthetic, abrasion resistant, strongly radiopaque and high gloss polish able.

Intended Use: For anterior and limited posterior restorations and sealings in dentistry

Stick™ Flow is substantially equivalent to Aeliteflo™, approved under 510(k) number K955292 dated December 13, 1995.

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is a stylized image of three wavy lines, which are meant to represent a human figure.

## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 9 2003

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

Re: K031341

Trade/Device Name: Stick Flow Regulation Number: 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: August 8 , 2003 Received: August 11, 2003

Dear Mr. Troetal:

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. Troetel

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/dsma/dsmamain.html

Sincerely yours,

Ques

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 B.

5 · 0(k) Number (if known): _ K (31341

Device Name: Stick™ Flow

Indications for Use:

- A flowable light cure microhybrid composite for tooth filling, sealing and . cementing.
Kein Mulay for MSR

(Divisi Division of Anesthesiology, General Ho on Control. Dental D

510(k) Number

(FLEASE 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)