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510(k) K231480

Bright MTA Sealer Plus by Genoss Co., Ltd. — Product Code KIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 2023
Date Received
May 22, 2023
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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  • K200155 — Bright High Flow (November 30, 2020)
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  • K170596 — TN-Brush (September 11, 2017)
  • K160079 — rainbow Shine (November 10, 2016)

Other clearances for product code KIF

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  • K251465 — Root canal repair materials (nRoot BP) (September 25, 2025)
  • K252285 — Well-Root PT (September 19, 2025)
  • K251884 — One-Fil Putty Injectable (August 22, 2025)
  • K251390 — MTA vpt (July 3, 2025)
  • K250710 — Injectable Root Canal Bioceramic Sealer (nRoot SP) (June 11, 2025)
  • 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)