PMA P930021

Device
Straumann Emdogain
Applicant
The Straumann Company
PMA number
P930021
Supplement
S030
Product code
NQA
Decision date
2025-09-05
Generic name
Biologic material, dental
Approval order statement
implementation of new Blue zone cleanroom area (ISO 7/8)

Current openFDA PMA Record#

Device
Straumann Emdogain
Applicant
The Straumann Company
PMA number
P930021
Supplement
S034
Product code
NQA
Generic name
Biologic material, dental
Decision date
2025-09-05
Decision code
OK30
Date received
2025-08-07
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
implementation of new Blue zone cleanroom area (ISO 7/8)