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510(k) K172169

Pulpdent (Activa) Pit and Fissure Sealant with MCP by Pulpdent Corporation — Product Code EBC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 5, 2018
Date Received
July 18, 2017
Clearance Type
Traditional
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 Pulpdent Corporation

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  • K173020 — OBA-MCP, Orthodontic Bracket Adhesive with MCP (January 17, 2018)
  • K153249 — Pulpdent Solo Flowable Composite with MCP (April 1, 2016)
  • K130223 — RMGI FILL (March 29, 2013)
  • K123265 — RMGI LOW VISCOSITY (December 7, 2012)
  • K120784 — TUFF-TEMP 2.0 (June 8, 2012)
  • K120003 — NUCAL (April 5, 2012)
  • K120213 — ETCH-RITE SUPREME (March 30, 2012)
  • K113818 — EMBRACE WETBOND PIT AND FISSURE SEALANT, LOW FILL (March 21, 2012)
  • K113711 — LIME-LITE II (March 5, 2012)

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  • K230455 — Enamel Coating Resin (July 25, 2023)
  • K190998 — BA Pit & Fissure Sealant (November 8, 2019)
  • K190339 — Helioseal F Plus (July 29, 2019)
  • 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)