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FDA 510(k) Application Details - K182329
Device Classification Name
Aligner, Sequential
More FDA Info for this Device
510(K) Number
K182329
Device Name
Aligner, Sequential
Applicant
Digital Orthodontic Care
348 Bronte Street, Unit 16
Milton L925B6 CA
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Contact
Jeff Sheppard
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
08/28/2018
Decision Date
11/08/2018
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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