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510(k) K250015

Ormco™ EtchFree Bonding System, Ormco™ EtchFree Bonding Primer, Ormco™ EtchFree Adhesive by Ormco Corporation — Product Code DYH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 3, 2025
Date Received
January 2, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

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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