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FDA 510(k) Application Details - K221537
Device Classification Name
Aligner, Sequential
More FDA Info for this Device
510(K) Number
K221537
Device Name
Aligner, Sequential
Applicant
Smylio Inc.
48890 Milmont Dr. Ste 101D
Fremont, CA 94538 US
Other 510(k) Applications for this Company
Contact
Ren Menon
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
05/27/2022
Decision Date
04/05/2023
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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