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FDA 510(k) Application Details - K203737
Device Classification Name
Aligner, Sequential
More FDA Info for this Device
510(K) Number
K203737
Device Name
Aligner, Sequential
Applicant
Ormco Corporation
200 S Kraemer Blvd
Brea, CA 92821 US
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Contact
Frank Ray
Other 510(k) Applications for this Contact
Regulation Number
872.5470
More FDA Info for this Regulation Number
Classification Product Code
NXC
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More FDA Info for this Product Code
Date Received
12/22/2020
Decision Date
03/22/2021
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
N
Expedited Review
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