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510(k) K080203

MTA ROOT CANAL SEALER by Dentsply Interntional — Product Code KIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 26, 2008
Date Received
January 28, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Resin, Root Canal Filling
Device Class
Class II
Regulation Number
872.3820
Review Panel
DE
Submission Type

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  • K080246 — COMPOSITE ALIGNER BUTTON (April 11, 2008)
  • K073173 — SELF-ADHESIVE RESIN CEMENT (January 23, 2008)
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