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FDA 510(k) Application Details - K981095
Device Classification Name
Aligner, Sequential
More FDA Info for this Device
510(K) Number
K981095
Device Name
Aligner, Sequential
Applicant
ALIGN TECHNOLOGY
18140 SMOKESIGNAL DR.
SAN DIEGO, CA 92127 US
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Contact
CAROL PATTERSON
Other 510(k) Applications for this Contact
Regulation Number
872.5470
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Classification Product Code
NXC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/26/1998
Decision Date
09/08/1998
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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