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510(k) K190998

BA Pit & Fissure Sealant by Apex Dental Materials, Inc. — Product Code EBC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 8, 2019
Date Received
April 16, 2019
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sealant, Pit And Fissure, And Conditioner
Device Class
Class II
Regulation Number
872.3765
Review Panel
DE
Submission Type

Other clearances by Apex Dental Materials, Inc.

  • K161077 — RnD TE and RnD SE (March 17, 2017)
  • K131043 — APEX UNIVERSAL ADHESIVE (September 10, 2013)
  • K131049 — ZRP (August 27, 2013)
  • K120620 — CLEAN AND BOOST (May 31, 2012)
  • K110859 — METAL OPAQUER (June 23, 2011)
  • K092539 — SEAMFREE (October 1, 2009)
  • K091647 — INJECTAFIL (September 21, 2009)
  • K062157 — CONFORM (October 13, 2006)
  • K061981 — SURPASS (July 31, 2006)
  • K053103 — INTERFACE (February 1, 2006)

Other clearances for product code EBC

  • K243254 — Parkell Pit and Fissure Sealant (August 8, 2025)
  • K232498 — UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection b (August 18, 2023)
  • K230455 — Enamel Coating Resin (July 25, 2023)
  • K190339 — Helioseal F Plus (July 29, 2019)
  • K172169 — Pulpdent (Activa) Pit and Fissure Sealant with MCP (January 5, 2018)
  • K171330 — Nanova Sealant (September 8, 2017)
  • K162598 — HAPI Seal (May 23, 2017)
  • K161580 — Premier Sealant (October 18, 2016)
  • K141717 — PACSEAL PIT & FISSURE SEALANT (March 9, 2015)
  • K130485 — CONTROL SEAL (February 11, 2014)