PMA P930021S029

Device: Straumann® Emdogain®
Applicant: The Straumann Company
PMA number: P930021
Supplement: S029
Product code: NQA
Decision date: 2022-11-16
Generic name: Biologic material, dental
Approval order statement: Improved settings for HPLC identification (ID) method for Emdogain (test method for in-process control and final release testing);2) Removal of redundant Acetic acid content determination (release testing);3) Removal of one redundant Calcium concentration determination (in-process control); and4) Removal of redundant sampling step on Emdogain gel bulk(in-process control.

Current openFDA PMA Record#

Device: Straumann® Emdogain®
Applicant: The Straumann Company
PMA number: P930021
Supplement: S029
Product code: NQA
Generic name: Biologic material, dental
Decision date: 2022-11-16
Decision code: OK30
Date received: 2022-10-17
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Improved settings for HPLC identification (ID) method for Emdogain (test method for in-process control and final release testing);2) Removal of redundant Acetic acid content determination (release testing);3) Removal of one redundant Calcium concentration determination (in-process control); and4) Removal of redundant sampling step on Emdogain gel bulk(in-process control.