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FDA 510(k) Application Details - K220287
Device Classification Name
Aligner, Sequential
More FDA Info for this Device
510(K) Number
K220287
Device Name
Aligner, Sequential
Applicant
Align Technology, Inc.
2820 Orchard Parkway
San Jose, CA 95134 US
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Contact
Shweta Daga
Other 510(k) Applications for this Contact
Regulation Number
872.5470
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Classification Product Code
NXC
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More FDA Info for this Product Code
Date Received
02/01/2022
Decision Date
04/07/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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