Home / 510(k) Clearances / K802679

510(k) K802679

SILANIT by Vivadent (Usa), Inc. — Product Code EBG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 1980
Date Received
October 28, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Crown And Bridge, Temporary, Resin
Device Class
Class II
Regulation Number
872.3770
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)
  • K802684 — HELIOMAT (November 24, 1980)
  • K802682 — CONTACT SEAL (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 EBG

  • K253380 — “FLNT Base” and “FLNT Temp” (March 2, 2026)
  • K251271 — TempFIT Temporary Crown and Bridge Resin (June 23, 2025)
  • K243370 — DentaTOOTH (May 5, 2025)
  • K243621 — Evoblock, Perléon (April 22, 2025)
  • K243951 — TEMP MASTER, PMMA-based dental resin (February 21, 2025)
  • K231859 — PrimmaArt (November 26, 2024)
  • K242559 — Digital Temp (November 26, 2024)
  • K240538 — Premium Teeth Resin (July 19, 2024)
  • K241226 — Fixtemp® C&B 4:1 (May 31, 2024)
  • K233868 — dima Print Teeth & Temp (May 23, 2024)