Home / 510(k) Clearances / K241226

510(k) K241226

Fixtemp® C&B 4:1 by Dreve Denatmid GmbH — Product Code EBG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 31, 2024
Date Received
May 2, 2024
Clearance Type
Special
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 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)
  • K233868 — dima Print Teeth & Temp (May 23, 2024)
  • K223706 — PMMA BLOCK (May 12, 2023)