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  5. Laboratorios Dentales De Zona Franca, S.A. - 607719 - 08/20/2021
  1. Warning Letters

CLOSEOUT LETTER

Laboratorios Dentales De Zona Franca, S.A. MARCS-CMS 607719 —

Product:
Medical Devices
Recipient:
Recipient Name
Mr. James R. Glidewell
Recipient Title
President and Chief Executive Officer
Laboratorios Dentales De Zona Franca, S.A.
Prismatik Dentalcraft, Inc.

2144 Michelson Dr.
Irvine, CA 92612
United States

Issuing Office:
Center for Devices and Radiological Health

United States

Dear Mr. Glidewell:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS #607719, dated May 15, 2020). Based on our evaluation, it appears that you have addressed the violations 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 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,
/S/
Michael E. Adjodha, M.ChE.
Assistant Director
Division of Dental and ENT Devices
OHT1: Office of Ophthalmic, Anesthesia,
Respiratory, ENT and Dental Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

CC:
Herbert Schoenhoefer
Director of Regulatory Affairs and Quality Assurance
U.S. Agent for Laboratorios Dentales De Zona Franca, S.A.
Prismatik Dentalcraft Inc.
2144 Michelson Dr.
Irvine, CA 92612

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