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FDA 510(k) Application Details - K223632
Device Classification Name
Material, Tooth Shade, Resin
More FDA Info for this Device
510(K) Number
K223632
Device Name
Material, Tooth Shade, Resin
Applicant
Premier Dental Products Company
1710 Romano Drive
Plymouth Meeting, PA 19462-4500 US
Other 510(k) Applications for this Company
Contact
Jessica Huang
Other 510(k) Applications for this Contact
Regulation Number
872.3690
More FDA Info for this Regulation Number
Classification Product Code
EBF
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/05/2022
Decision Date
12/06/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
Y
Expedited Review
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