DISCOVRED

Device, Caries Detection

PHOENIX DENTAL, INC.

The following data is part of a premarket notification filed by Phoenix Dental, Inc. with the FDA for Discovred.

Pre-market Notification Details

• Device ID: K102821
• 510k Number: K102821
• Device Name: DISCOVRED
• Classification: Device, Caries Detection
• Applicant: PHOENIX DENTAL, INC. 3452 WEST THOMPSON RD. Fenton, MI 48430
• Contact: Jeffrey S Cox
• Correspondent: Jeffrey S Cox; PHOENIX DENTAL, INC. 3452 WEST THOMPSON RD. Fenton, MI 48430
• Product Code: LFC
• CFR Regulation Number: 872.1740 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-09-28
• Decision Date: 2011-03-11
• Summary: summary