PMA P930021S010

Device: EMODOGAIN
Applicant: The Straumann Company
PMA number: P930021
Supplement: S010
Product code: NQA
Decision date: 2007-11-28
Classification: Biologic Material, Dental
Generic name: Biologic material, dental
Approval order statement: APPROVAL FOR TWO MODIFICATIONS TO THE DEVICE INSTRUCTIONS FOR USE: 1) A MODIFICATION OF THE DESCRIPTION OF EMODOGAIN, AND 2) A RESTRICTION OF THE RECOMMENDATION TO THE USE OF PREFGEL TOOTH CONDITIONER.

Current openFDA PMA Record#

Device: EMODOGAIN
Applicant: The Straumann Company
PMA number: P930021
Supplement: S010
Product code: NQA
Generic name: Biologic material, dental
Decision date: 2007-11-28
Decision code: APPR
Date received: 2007-10-09
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR TWO MODIFICATIONS TO THE DEVICE INSTRUCTIONS FOR USE: 1) A MODIFICATION OF THE DESCRIPTION OF EMODOGAIN, AND 2) A RESTRICTION OF THE RECOMMENDATION TO THE USE OF PREFGEL TOOTH CONDITIONER.