Laboratorios Dentales De Zona Franca, S.A.

CLOSEOUT LETTER Laboratorios Dentales De Zona Franca, S.A. MARCS-CMS 607719 — August 20, 2021 More Warning Letters Warning Letters About Warning and Close-Out Letters 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 Content current as of: 09/22/2021 Regulated Product(s) Medical Devices