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510(k) K102163

REALSEAL XT SEALER by Kerr Corporation — Product Code KIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 16, 2010
Date Received
August 2, 2010
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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  • K162164 — GingiKnit+, GingiBraid+, and Shortcut with GingiBraid+ Non-Impregnated Retractio (January 13, 2017)
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  • K243353 — One-Fil Putty (March 14, 2025)
  • K243546 — AH Plus Endodontic Sealer (February 13, 2025)
  • K242934 — Bioceramic Root Canal Sealer and Repair Materials (i-MTA BP) (December 12, 2024)