BIOCRYL X

K083479 · Great Lakes Orthodontics, Ltd. · EBI · Feb 27, 2009 · Dental

Device Facts

• Record ID: K083479
• Device Name: BIOCRYL X
• Applicant: Great Lakes Orthodontics, Ltd.
• Product Code: EBI · Dental
• Decision Date: Feb 27, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3760
• Device Class: Class 2

Intended Use

Biocryl X is intended for the laboratory fabrication of radiographic templates to be worn by a patient during x-ray imaging.

Device Story

Biocryl X is a radiopaque, auto-polymerizing powder/liquid dental acrylic system. It is used in a laboratory setting by dental technicians to fabricate radiographic templates. These templates are worn by patients during x-ray imaging procedures to assist in diagnostic visualization. The device functions as a material for creating custom dental appliances.

Clinical Evidence

Bench testing only. Performance data evaluated mechanical properties (hardness, exotherm, water absorption, extractables, working times) and biocompatibility (non-cytotoxic, non-irritant, non-sensitizer).

Technological Characteristics

Auto-polymerizing powder/liquid dental acrylic system. Radiopaque. Evaluated for mechanical properties and biocompatibility.

Indications for Use

Indicated for the fabrication of dental radiographic templates worn by patients during x-ray imaging.

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

• Biocryl™

Submission Summary (Full Text)

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KOS 3472

Image /page/0/Picture/1 description: The image is a logo for Great Lakes Orthodontics. The logo features an outline of the United States with the Great Lakes highlighted in white. The words "GREAT LAKES" are written in a circular fashion above the image, and the word "ORTHODONTICS" is written in a circular fashion below the image.

FEB 2 7 2009

# Great Lakes Orthodontics, LTD.

An Employee Owned Company

Our Vision "Delight our customers. Respect and help our co-workers." 510(k) SUMMARY

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

DATE PREPARED: November 20, 2008

### TRADE OR PROPRIETARY NAME: Biocryl X

COMMON NAME: Radiopaque dental acrylic, cold-cure acrylic CLASSIFICATION NAME: Denture relining, repairing, or rebasing (872.3760) PRODUCT CODE: EBI

PREDICATE DEVICE: Biocryl™

Great Lakes Orthodontics 200 Cooper Avenue Tonawanda, NY 14150

### DEVICE DESCRIPTION

Biocryl X is a radiopaque, auto-polymerizing powder/liquid dental acrylic system.

INTENDED USE

Biocryl X is intended for the laboratory fabrication of radiographic templates to be worn by a patient during x-ray imaging.

### TECHNOLOGICAL CHARACTERISTICS COMPARED TO PREDICATE DEVICE

Biocryl X was evaluated as follows:

Mechanical properties, Hardness, Exotherm, Water absorption and extractables, and Working times.

Biocryl X was also evaluated as follows:

Agar Diffusion Assay Mucous Membrane Irritation Klingman Maximization Test non-cytotoxic non-irritant non-sensitizer

We conclude that the similarity in comparison between Biocryl X and the predicate device, as well as the performance data and biocompatibility results, support the safety and effectiveness of Biocryl X for the indicated uses.

200 Cooper Avenue · P.O. Box 5111_+ Tonawanda, New York 14151-5111 800-828-7626 716-871-1161 . . Fax [phone] e-mail: [e-mail] . Website: www.greatlakesortho.com

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## FEB 2 7 2009

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

Re: K083479

Trade/Device Name: Biocryl X Regulation Number: 21 CFR 872.3760 Regulation Name: Denture Relining, Repairing, or Rebasing Resin Regulatory Class: II Product Code: EBI Dated: December 19, 2008 Received: December 19, 2008

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 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 vour 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. 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 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/industry/support/index.html.

Sincerely yours,

Susan Kunner

Sineta V. Michael, MD

Ginette Y. Michaud, M.D. Acting 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): K083479

Device Name: Biocryl X

Indications For Use:

Biocryl X is indicated for the fabrication of dental radiographic templates worn during x-ray imaging.

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

Over-The-Counter Use (21 CFR 801 Subpart C)

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

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Su Concurrence of CDRH, Office of Device Evaluation (ODE)

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

108 8470

510(k) Numbar:

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