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PMA P930021S019

Device
Straumann Emdogain
Applicant
The Straumann Company
PMA number
P930021
Supplement
S019
Product code
NQA
Decision date
2018-08-14
Classification
Biologic Material, Dental
Generic name
Biologic material, dental
Approval order statement
Approval for the change made to an original “visual inspection” room E166. The room was remodeled by means of taking down dividing walls and extended to incorporate existing E143 “labeling” space to form one large “labeling” room. Both rooms are considered to be “clean rooms”.

Current openFDA PMA Record#

Device
Straumann Emdogain
Applicant
The Straumann Company
PMA number
P930021
Supplement
S019
Product code
NQA
Generic name
Biologic material, dental
Decision date
2018-08-14
Decision code
APPR
Date received
2018-04-13
Supplement type
135 Review Track For 30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Approval for the change made to an original “visual inspection” room E166. The room was remodeled by means of taking down dividing walls and extended to incorporate existing E143 “labeling” space to form one large “labeling” room. Both rooms are considered to be “clean rooms”.