Home / 510(k) Clearances / K110058

510(k) K110058

BPA-FREE PIT AND FISSURE SEALANT by Novocol Inc. Dba Septodont and Confi-Dental Produc — Product Code EBC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 2011
Date Received
January 10, 2011
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 Novocol Inc. Dba Septodont and Confi-Dental Produc

  • K101540 — GRANITEC DUAL-CURE CORE BUILD-UP, N'DURANCE DIMER CORE (October 29, 2010)

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)
  • K190998 — BA Pit & Fissure Sealant (November 8, 2019)
  • 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)