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510(k) K941015

ORMCO SYSTEM 1+ (TM) by Ormco Corp. — Product Code DYH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 1994
Date Received
March 3, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Adhesive, Bracket And Tooth Conditioner, Resin
Device Class
Class II
Regulation Number
872.3750
Review Panel
DE
Submission Type

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