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510(k) K112078

ENDOCEM MTA (MINERAL TRIOXIDE AGGREGATE) by Maruchi — Product Code KIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 19, 2012
Date Received
July 21, 2011
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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  • K201799 — CleaniCal (February 12, 2021)
  • K170175 — ENDOSEAL MTA (February 26, 2018)
  • K133054 — ENDOSEAL (May 12, 2014)
  • K133042 — ENDOCEM ZR (May 12, 2014)

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  • K243353 — One-Fil Putty (March 14, 2025)
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