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510(k) K802682

CONTACT SEAL by Vivadent (Usa), Inc. — Product Code EBC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 24, 1980
Date Received
October 28, 1980
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 Vivadent (Usa), Inc.

  • K863831 — VIVADENT FILPIN (October 14, 1986)
  • K823409 — HELIOSIT-ORTHODONTIC (January 21, 1983)
  • K813015 — HELIOSEAL (December 2, 1981)
  • K802679 — SILANIT (December 17, 1980)
  • K802684 — HELIOMAT (November 24, 1980)
  • K802683 — HELIOSIT (November 24, 1980)
  • K802681 — HELIOBOND (November 24, 1980)
  • K802680 — ISOPAST-DS (November 12, 1980)
  • K802685 — REOLIT (November 12, 1980)
  • K801227 — SILICAP (August 12, 1980)

Other clearances for product code EBC

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  • 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)