Home / 510(k) Clearances / K123278

510(k) K123278

IBOND SELF ETCH BOTTLE ASSORTMENT, IBOND SELF ETCH BOTTLE VALUE PACK, IBOND SELF ETCH SINGLE DOSE ASSORTMENT, IBOND SELF by Heraeus Kulzer, LLC — Product Code KLE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 7, 2012
Date Received
October 22, 2012
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Agent, Tooth Bonding, Resin
Device Class
Class II
Regulation Number
872.3200
Review Panel
DE
Submission Type

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