PMA P040013S027

Device: GEM21S Growth Factor Enhanced Matrix
Applicant: Lynch Biologics, LLC
PMA number: P040013
Supplement: S027
Product code: NPZ
Decision date: 2023-05-04
Classification: Dental
Generic name: Bone grafting material, dental, with biologic component
Approval order statement: Approval for the addition of a Flurotec coating to the piston stopper component in the syringe system of the final finished packaging.

Current openFDA PMA Record#

Device: GEM21S Growth Factor Enhanced Matrix
Applicant: Lynch Biologics, LLC
PMA number: P040013
Supplement: S027
Product code: NPZ
Generic name: Bone grafting material, dental, with biologic component
Decision date: 2023-05-04
Decision code: APPR
Date received: 2022-11-15
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for the addition of a Flurotec coating to the piston stopper component in the syringe system of the final finished packaging.