EVERSTICK POST

K030820 · Stick Tech , Ltd. · ELR · May 20, 2003 · Dental

Device Facts

• Record ID: K030820
• Device Name: EVERSTICK POST
• Applicant: Stick Tech , Ltd.
• Product Code: ELR · Dental
• Decision Date: May 20, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3810
• Device Class: Class 1

Intended Use

Intended for use as a fiber reinforced root canal post

Device Story

everStick™ POST is a semi-manufactured dental device composed of unidirectional glass fibers embedded in a polymer/resin matrix. It functions as a root canal reinforcement post to increase the strength and stiffness of dental restorations. The device is used by dentists in a clinical setting. The clinician shapes and places the post within the root canal to provide structural support for the final restoration. By reinforcing the tooth structure, the device aims to improve the durability and longevity of dental repairs. It is supplied as a pre-formed material that is adapted by the practitioner during the restorative procedure.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and material composition comparisons to legally marketed predicate devices.

Technological Characteristics

Semi-manufactured root canal post; unidirectional glass fibers in a polymer/resin matrix. Dimensions and form factor are designed for root canal reinforcement. No specific ASTM standards cited. Device is a passive structural reinforcement material; no energy source or software components.

Indications for Use

Indicated for use as a fiber reinforced root canal post in dental patients requiring root canal reinforcement.

Regulatory Classification

Identification

A root canal post is a device made of austenitic alloys or alloys containing 75 percent or greater gold and metals of the platinum group intended to be cemented into the root canal of a tooth to stabilize and support a restoration.

Predicate Devices

• everStick™ (K011788)
• Ribbond (K913040)

Submission Summary (Full Text)

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KO308do

## 510(k) Summary F.

| 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<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: | March 17th, 2003 |
| Device Trade Name: | everStick™ POST |
| Device Common Name: | Glass fiber root canal reinforcement |
| Device Classification Name: | Denture relining, repairing, or rebasing resin |
| | (21 CFR §872.3760) |

Description of Device:

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

Intended use: Glass fiber reinforcement for dentistry

everStick™ POST is substantially equivalent to everStick™, approved under 510(k) number K011788 dated November 7, 2001 and Ribbond, approved under K913040 dated October7, 1991.

The composition of everStick™ POST is equal with its predicate device, everStick™ with the same technological characteristics. Only the ratio of glass fibers and

F-1

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polymer matrices are slightly different. The second predicate device Ribbond has the same intended use as everStick™ POST but different technological characteristics that do not raise new questions of safety and effectiveness.

By comparing the ingredients of everStick™ POST to the existing data available from dental polymerizable material it can be stated that everStick™ POST does not expose the dentist or the patient to unacceptable risks.

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a series of flowing lines, possibly representing human profiles or interconnectedness.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 0 2003

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

Re: K030820

Trade/Device Name: everStick™ POST Regulation Number: 21 CFR 872.3810 Regulation Name: Root Canal Post Regulatory Class: I Product Code: ELR Dated: March 14, 2003 Received: March 14, 2003

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 Cosnetic 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 - William M. Troetel, Ph.D.

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 (OS) 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]. 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) you may obtain. 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,

Suses Pinar

Susan Runner, DDS, MA Interim 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.

1030820 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________ Device Name: everStick™ POST Indications for Use:

Intended for use as a fiber reinforced root canal post ●

(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) ાર

Over-the-Counter Use _

Keen Muly fa wish
(Optionai Format 1-2-96)

(Division Sign-Off) Division of Anesthesiology, General Hospital. tion Control. Dental Device

510(k) Number: K030820