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FDA 510(k) Application Details - K223892
Device Classification Name
Material, Impression
More FDA Info for this Device
510(K) Number
K223892
Device Name
Material, Impression
Applicant
Innovative Product Brands, Inc.
7045 Palm Avenue
Highland, CA 92346 US
Other 510(k) Applications for this Company
Contact
Shane Nielsen
Other 510(k) Applications for this Contact
Regulation Number
872.3660
More FDA Info for this Regulation Number
Classification Product Code
ELW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/28/2022
Decision Date
04/27/2023
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
N
Expedited Review
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