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FDA 510(k) Application Details - K211010
Device Classification Name
Aligner, Sequential
More FDA Info for this Device
510(K) Number
K211010
Device Name
Aligner, Sequential
Applicant
Laxmi Dental Exports Pvt Ltd
Survey No. 201/1, Village Gundale, Boisar Chillar Highway
Boisar 401501 IN
Other 510(k) Applications for this Company
Contact
Sameer Merchant
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
04/05/2021
Decision Date
04/26/2021
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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