FASTRAY LC

K991631 · Harry J. Bosworth Co. · ELW · Jul 26, 1999 · Dental

Device Facts

• Record ID: K991631
• Device Name: FASTRAY LC
• Applicant: Harry J. Bosworth Co.
• Product Code: ELW · Dental
• Decision Date: Jul 26, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3660
• Device Class: Class 2

Indications for Use

Light curing resin in form of contoured wafers for the fabrication of custom trays.

Device Story

Fastray LC consists of light-curing resin contoured wafers used by dental professionals to fabricate custom dental trays. The device is applied manually to create a custom fit for dental impressions. It requires an external light-curing source to polymerize and harden the resin material. The resulting custom tray is used by the clinician to facilitate accurate dental impressions for patient treatment. The device simplifies the tray fabrication process compared to traditional self-curing acrylics.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Light-curing resin material provided in pre-contoured wafer form. Requires external light source for polymerization. Class II device (Product Code ELW).

Indications for Use

Indicated for use as a light-curing resin in the form of contoured wafers for the fabrication of custom dental trays.

Regulatory Classification

Identification

Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.

Special Controls

*Classification.* Class II (Special Controls).

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three stripes forming its body and head. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 26 1999

Ms. Mildred M. Goldstein President Harry J. Bosworth Company 7227 North Hamlin Avenue Skokie, Illinois 60076-3999

Re : K991631 Fastray LC Trade Name: Requlatory Class: II Product Code: ELW May 7, 1999 Dated: Received: May 11, 1999

Dear Ms. Goldstein:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Goldstein

this response to your premarket notification Please note: submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA findinq 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 and additionally 809.10 for in vitro diagnostic devices), 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" (21 CFR 807.97). Other gener Other qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.qov/cdrh/dsmamain.html".

Sincerely yours

Timothy A. Ulatowski

Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indication For Use

510(K) Number:_

Device Name: Fastray LC

Indications For Use:

Light curing resin in form of contoured wafers for the fabrication of custom trays.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)

Susan Kearns

**CONFIDENTIAL**

on Control, 11:00 and General Hos 510(k) Number