Premarket Approval (PMA)

Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.

• Trade Name: BIORA EMDOGAIN(R)
• Classification Name: biologic material, dental
• Generic Name: enamel derivative
• Regulation Number: 872.3930
• Applicant: THE STRAUMANN COMPANY
• PMA Number: P930021
• Date Received: 07/19/1993
• Decision Date: 09/30/1996
• Product Code: NQA [ Registered Establishments with NQA ]
• Docket Number: 96M-0482
• Notice Date: 11/21/1996
• Advisory Committee: Dental
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Approval for the emdogain.

• Supplements: S001 S002 S003 S004 S005 S006 ; S007 S008 S009 S010 S011 S012