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510(k) K924824

MICRODOSE PIT AND FISSURE SEALANT-CLEAR OR WHITE by Unicep — Product Code EBC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 16, 1993
Date Received
September 28, 1992
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 Unicep

  • K925163 — MICODOSE CHLORHEXIPREP (May 27, 1993)
  • K924821 — MICRODOSE PORCELAIN ETCHANT (March 16, 1993)
  • K924823 — MICRODOSE SILANE (March 16, 1993)
  • K925162 — MICRODOSE DENTIN CONDITIONER (March 16, 1993)
  • K924826 — MICRODOSE TOTAL ETCHANT (March 5, 1993)
  • K924825 — MICRODOSE RC-EZ (March 5, 1993)
  • K924822 — MICRODOSE ENAMEL ETCHANT (March 5, 1993)
  • K924827 — MICRODOSE POTASSIUM OXYLATE (March 5, 1993)

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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)
  • 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)