SYNERGY

Bone Grafting Material, Animal Source

ODONTIT SA

The following data is part of a premarket notification filed by Odontit Sa with the FDA for Synergy.

Pre-market Notification Details

• Device ID: K123876
• 510k Number: K123876
• Device Name: SYNERGY
• Classification: Bone Grafting Material, Animal Source
• Applicant: ODONTIT SA 2600 MULLINIX MILL ROAD Mt Airy, MD 21771
• Contact: Blix Winston
• Correspondent: Blix Winston; ODONTIT SA 2600 MULLINIX MILL ROAD Mt Airy, MD 21771
• Product Code: NPM
• CFR Regulation Number: 872.3930 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-12-17
• Decision Date: 2014-05-22
• Summary: summary