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510(k) K211101

E-Temp by Envisiontec GmbH — Product Code EBG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 14, 2021
Date Received
April 13, 2021
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 Envisiontec GmbH

  • K220894 — SmileGuard (June 10, 2022)
  • K210977 — E-Dent 1000 (May 25, 2021)
  • K203641 — E-Denture Pro (March 30, 2021)
  • K201173 — E-Guard (November 27, 2020)

Other clearances for product code EBG

  • K261261 — Dura-Arch (April 17, 2026)
  • 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)