Premarket Approval (PMA)

Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.

• Trade Name: EMDOGAIN
• Classification Name: biologic material, dental
• Generic Name: enamel derivative
• Regulation Number: 872.3930
• Applicant: THE STRAUMANN CO.
• PMA Number: P930021
• Supplement Number: S009
• Date Received: 04/11/2006
• Decision Date: 04/24/2006
• Product Code: NQA [ Registered Establishments with NQA ]
• Advisory Committee: Dental
• Supplement Type: Special Supplement
• Supplement Reason: labeling change - other
• Expedited Review Granted?: No
• Combination Product: Yes

Approval Order Statement 
Approval for the addition of post-market experience information to the warning section of the emdogain package insert.