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FDA 510(k) Application Details - K200077
Device Classification Name
Varnish, Cavity
More FDA Info for this Device
510(K) Number
K200077
Device Name
Varnish, Cavity
Applicant
Dr. Collins, Inc.
4330 Barranca Pkwy. Ste #100
Irvine, CA 92604 US
Other 510(k) Applications for this Company
Contact
Jiahe Li
Other 510(k) Applications for this Contact
Regulation Number
872.3260
More FDA Info for this Regulation Number
Classification Product Code
LBH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/14/2020
Decision Date
11/06/2020
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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