FDA Requires 510K on Dental/Medical Diagnostic's Intraoral Cameras

The US Food and Drug Administration notified Dental/ Medical Diagnostic Systems Inc. (Westlake Village, CA) that a 510(K) Notification pursuant to Section 510(K) of the federal Food, Drug and Cosmetic Act will be required on all intraoral cameras sold in the United States, including the company's TeliCam product.

The staff of the FDA also verbally confirmed that the company may continue to sell the TeliCam domestically and internationally pending clearance of the product. The company believes that the marketing and sales of the TeliCam intraoral dental camera does not require filing or clearance of a 510(K) Notification and would vigorously challenge any enforcement action based upon such a contention. However, the company has decided to promptly comply with the staff's direction since there will be no negative affect on the sales or operations of the company.

The company and its regulatory experts believe that the obtaining of the 510(K) Notification for the camera will be a relatively easy process and should be completed in the next two to three months.