HYPERION

System, X-ray, Extraoral Source, Digital

CEFLA S.C. CEFLA DENTAL GROUP

The following data is part of a premarket notification filed by Cefla S.c. Cefla Dental Group with the FDA for Hyperion.

Pre-market Notification Details

• Device ID: K113497
• 510k Number: K113497
• Device Name: HYPERION
• Classification: System, X-ray, Extraoral Source, Digital
• Applicant: CEFLA S.C. CEFLA DENTAL GROUP VIA BICOCCA N.14/C Imola, IT B040026
• Contact: Marisa Testa
• Correspondent: William Sammons; INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087
• Product Code: MUH
• CFR Regulation Number: 872.1800 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: Yes
• Combination Product: No
• Date Received: 2011-11-25
• Decision Date: 2012-01-17