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PMA P930021S032

Device
Straumann Emdogain
Applicant
The Straumann Company
PMA number
P930021
Supplement
S032
Product code
NQA
Decision date
2023-06-21
Classification
Dental
Generic name
Biologic material, dental
Approval order statement
Relocation of Visual Inspection and Blistering activities to new cleanrooms in house K to release space for manufacturing of other products in the clean room areas but will also be beneficial for the Emdogain process since it will lead to a better material flow between clean room areas and warehouse.

Current openFDA PMA Record#

Device
Straumann Emdogain
Applicant
The Straumann Company
PMA number
P930021
Supplement
S032
Product code
NQA
Generic name
Biologic material, dental
Decision date
2023-06-21
Decision code
OK30
Date received
2023-05-25
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Relocation of Visual Inspection and Blistering activities to new cleanrooms in house K to release space for manufacturing of other products in the clean room areas but will also be beneficial for the Emdogain process since it will lead to a better material flow between clean room areas and warehouse.