Home / 510(k) Clearances / K153067

510(k) K153067

Tubli-Seal, Tubli-Seal EWT,Tubli-Seal Xpress, Tubli-Seal EWT Xpress by Sybron Dental Specialties — Product Code KIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 2016
Date Received
October 22, 2015
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

Other clearances by Sybron Dental Specialties

  • K182826 — Ormco Spark Aligner System (October 11, 2018)
  • K162063 — Steri-Cassette and Steri-Cage Sterilization Packaging System (April 21, 2017)
  • K160097 — Image Fast Set, Image Regular Set (August 5, 2016)
  • K152956 — Pulp Canal Sealer, Pulp Canal Sealer EWT (May 6, 2016)
  • K152959 — Sealapex tubes, Sealapex bulk package, Sealapex Xpress dual-barrel syringes (April 14, 2016)
  • K151526 — Zone, ZoneFree, Zone A1 (September 10, 2015)
  • K151332 — Nexus Universal, Nexus Universal Chroma (August 17, 2015)
  • K150559 — Life Fast Set, Life Regular Set (June 19, 2015)
  • K143209 — SonicFill 2 (February 5, 2015)
  • K130869 — TAKE 1 ADVANCE (May 30, 2013)

Other clearances for product code KIF

  • K253167 — Any-Paste (January 12, 2026)
  • K252890 — ZenSeal Pro (January 7, 2026)
  • 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)