Straumann® Emdogain®
FDA premarket approval P930021/S029 · decided 2022-11-16
Approval details
- PMA number
- P930021
- Supplement
- S029
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Straumann® Emdogain®
- Generic name
- Biologic material, dental
- Applicant
- The Straumann Company
- Date received
- 2022-10-17
- Decision date
- 2022-11-16
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- NQA
- Advisory committee
- Dental
- Expedited review
- No
- Location
- Andover, MA
- 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.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.