METACRYL

K040881 · Great Lakes Orthodontics, Ltd. · EBI · May 25, 2004 · Dental

Device Facts

• Record ID: K040881
• Device Name: METACRYL
• Applicant: Great Lakes Orthodontics, Ltd.
• Product Code: EBI · Dental
• Decision Date: May 25, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3760
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Metacryl is intended for the chairside fabrication of soft denture reline.

Device Story

Metacryl is a chemically cured soft denture reline material used by dental professionals in a clinical setting. The device is applied chairside to fabricate soft relines for dentures, improving patient comfort and fit. It functions as a dental acrylic resin. The healthcare provider prepares and applies the material directly to the denture base; the chemical curing process allows for chairside completion without laboratory processing. This provides a direct benefit to the patient by enabling immediate adjustment or repair of denture fit during a single clinical visit.

Clinical Evidence

Bench testing only. Performance evaluated via mechanical properties (hardness, water absorption, discoloration, peel strength) and biocompatibility (ISO Agar Overlay Cytotoxicity Test, result: non-cytotoxic). No clinical data provided.

Technological Characteristics

Chemically cured soft denture reline resin. Evaluated for mechanical properties including hardness, water absorption, discoloration, and peel strength. Biocompatibility confirmed via ISO Agar Overlay Cytotoxicity Test.

Indications for Use

Indicated for chairside fabrication of soft relines for dentures in patients requiring denture adjustment or repair.

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

• Flexacryl Soft (Lang Dental Corporation)

Submission Summary (Full Text)

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MAY 2 5 2004

Image /page/0/Picture/1 description: The image is a logo for Great Lakes Orthodontics. The logo is a circle with the words "GREAT LAKES ORTHODONTICS" around the outside. In the center of the circle is an outline of the United States with the Great Lakes shown in white. The logo is black and white.

K04088,

## Great Lakes Orthodontics, LTD.

An Employee Owned Company

Our Vision "Delight our customers. Respect and help our co-workers."

## 510(k) SUMMARY

Great Lakes Orthodontics 800-828-7626 CONTACT PERSON: Mr. Mark Lauren [e-mail]

DATE PREPARED: April 2, 2004

TRADE OR PROPRIETARY NAME: Metacryl COMMON NAME: Dental acrylic, soft denture reline CLASSIFICATION NAME: Denture relining, repairing or rebasing resin 872.3760 PRODUCT CODE: EBI

Lang Dental Corporation PREDICATE DEVICE: Flexacryl Soft 175 Messner Drive Wheeling, IL 60090 800-222-5264

## DEVICE DESCRIPTION

Metacryl is a chemically cured soft denture reline. All components have been used in legally marketed devices or have been found to be safe for dental use.

INTENDED USE Mctacryl is intended for the chairside fabrication of soft denture reline.

TECHNOLOGICAL CHARACTERISTICS COMPARED WITH PREDICATE DEVICE Metacryl was evaluated as follows: Mechanical propertics, Hardness, Water absorption, Discoloration, Peel strength

Metacryl was also evaluated as follows:

ISO Agar Overlay Cytotoxicity Test non-cytotoxic

We conclude that the similarity in composition between Metacryl and the predicate device, as well as the performance data and biocompatibility results, supports the safety and effectiveness of Metacryl for the indicated uses.

200 Cooper Avenue · P.O. Box 5111 · Tonawanda, New York 14151-5111 ・ · 800-828-7626 Fax [phone] e-mail: [e-mail] · Website: www.greatlakesortho.com

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Image /page/1/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of what appears to be an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 5 2004

Mr. Mark Lauren Great Lakes Orthodontics, Limited 200 Cooper Avenue P.O. Box 5111 Tonawanda, New York 14151-5111

Re: K040881

Trade/Device Name: MetacryI™ Soft Denture Reline Regulation Number: 872.3760 Regulation Name: Denture Relining Repairing or Rebasing Resin Regulatory Class: II Product Codc: EBI Dated: April 2, 2004 Received: April 6, 2004

Dear Mr. Lauren:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially cquivalent (for the receiced above and 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 approvisions 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 cither class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 Nr.), I may of 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. Lauren

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 moun that 1 Drives and regulations administered by other Federal agencies. or the Fet of any a vith 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 fisting (21 certer in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as 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) I mis letter notification. The FDA finding of substantial equivalence of your device to a premainer results in a classification for your device and thus, pour 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), 11 you dontact 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 mitj overnit 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,

Charles

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): ____________________________________________________________________________________________________________________________________________________

Great Lakes Orthodontics 200 Cooper Avenue Tonawanda, NY 14150

Device Name: Metacry|™ soft denture reline

Indications for Use:

Metacryl ™ is intended for the chairside fabrication of soft relines for dentures.

Prescription Use ﺴﺴﺎ (21 CFR Part 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR Part 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Rung

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

Kouck 510(k) Number:_