Dental Technologies Inc.

CLOSEOUT LETTER Dental Technologies Inc. MARCS-CMS 612599 — September 02, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: Via Electronic Mail - Return Receipt Requested Product: Drugs Recipient: Recipient Name Mr. Stephen A Erickson Recipient Title President Dental Technologies Inc. 6901 N Hamlin Ave Lincolnwood , IL 60712 United States serickson@dentaltech.com Issuing Office: Division of Pharmaceutical Quality Operations III United States Secondary Issuing Offices United States Dear Mr. Erickson The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter, dated November 30, 2021. Based on our evaluation, it appears that you have adequately addressed the violations contained in this Warning Letter. 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, /S/ Brian Nicholson Brian Nicholson Compliance Officer, Division of Drug Quality I Office of Manufacturing Quality Office of Compliance Center for Drug Evaluation and Research Cc: Paula Erickson | Vice President perickson@dentaltech.com Content current as of: 09/04/2026 Regulated Product(s) Drugs