IMPAK ACRYLIC REPAIR RESIN LIQUID

K033020 · Cmp Industries, LLC · EBI · Dec 19, 2003 · Dental

Device Facts

• Record ID: K033020
• Device Name: IMPAK ACRYLIC REPAIR RESIN LIQUID
• Applicant: Cmp Industries, LLC
• Product Code: EBI · Dental
• Decision Date: Dec 19, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3760
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

resin is indicated for relining a denture surface which contains tissue, for repairing a fractured denture, or forming a new denture base.

Device Story

Impak Acrylic Repair Resin Liquid is a dental material used for denture relining, repairing fractured dentures, or forming new denture bases. It is intended for use by dental professionals. The liquid component is mixed with corresponding powder to form a resin, which is applied to the denture surface or mold. The material cures to provide a stable, functional denture base or repair. It serves as a restorative dental device to improve denture fit and structural integrity.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Denture relining, repairing, or rebasing resin. Product code EBI. Class II device per 21 CFR 872.3760.

Indications for Use

Indicated for patients requiring denture relining, repair of fractured dentures, or fabrication of new denture bases.

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.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human figures, one behind the other, with their heads tilted slightly forward.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 9 2003

Mr. William Regan CMP Industries LLC 413 North Pearl Street Albany, New York 12207

Re: K033020

Trade/Device Name: Impak Acrylic Repair Resin Liquid Regulation Number: 872.3760 Regulation Name: Denture Relining Repairing or Rebasing Resin Regulatory Class: II Product Code: EBI Dated: September 25, 2003 Received: September 26, 2003

Dear Mr. Regan:

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. Regan

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.

CluLs

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 → 510(k) Number (if known): KO33020 IMPAK MIRYLIC REPAIR LIQUID Device Name: CMP' IMPAK denture relining, repairing/rebasing liquid Indications For Use: resin is indicated for relining a denture surface which contains tissue, for repairing a fractured denture, or forming a new denture base. Over-The-Counter Use AND/OR Prescription Use (21 CFR 807 Subpart C) (P:irt 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF N EEDED)

Concurreince of CDRH, Office of Device Evaluation (ODE)

Susan Runore

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

033020 510(k) Number:________________________________________________________________________________________________________________________________________________________________

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