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FDA 510(k) Application Details - K190003
Device Classification Name
Aligner, Sequential
More FDA Info for this Device
510(K) Number
K190003
Device Name
Aligner, Sequential
Applicant
Orthodent Laboratory, Inc.
6325 Sheridan Drive
Buffalo, NY 14221 US
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Contact
Michael Wright
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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
01/02/2019
Decision Date
11/06/2019
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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