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510(k) K810950

VISIO-SEAL by Espe Dental Products — Product Code EBC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 1981
Date Received
April 7, 1981
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 Espe Dental Products

  • K802819 — KETAC-CEM IN REF. TO K802048 (November 24, 1980)
  • K802049 — NIMETIC-DISPERS (September 16, 1980)
  • K800031 — PERMADYNE POLYETHER RUBBER IMPRESSION (February 5, 1980)
  • K771901 — CAPMIX (October 20, 1977)
  • K771889 — UNIOLITE (October 20, 1977)
  • K771120 — IMPREFLEX ALGINATE IMPRESSION MATERIAL (August 3, 1977)
  • K771119 — PASTES, RESTORATIVE & TINTED, DEBTAL (July 15, 1977)

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  • 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)