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FDA 510(k) Application Details - K192596
Device Classification Name
Aligner, Sequential
More FDA Info for this Device
510(K) Number
K192596
Device Name
Aligner, Sequential
Applicant
uLab Systems, Inc.
6 Lagoon Drive, Suite 180
Redwood City, CA 94065 US
Other 510(k) Applications for this Company
Contact
Charlie Wen
Other 510(k) Applications for this Contact
Regulation Number
872.5470
More FDA Info for this Regulation Number
Classification Product Code
NXC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/20/2019
Decision Date
02/11/2020
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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