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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Sybron Dental Specialties, Inc.- Close Out Letter 10/2/12


Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration

10903 New Hampshire Avenue
Silver Spring, MD 20993

OCT 2, 2012

Mr. Vicente Reynal
President, Ormco Corporation
1717 West Collins Avenue
Orange, California 92867

Dear Mr. Reynal:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter (Warning Letter No. 313518), dated July 17, 2012. Based on our evaluation, it appears that your firm has addressed the violation contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.

This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your firm's state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.

Sincerely yours,


Steven D. Silverman
Office of Compliance
Center for Devices and
Radiological Health


     Ms. Colleen Boswell
     VP, Regulatory Affairs
     Sybron Dental Specialties, Inc.
     1717 West Collins Avenue
     Orange, California 92867