Home / 510(k) Clearances / K180562

510(k) K180562

TEMP BASIC, TEMP PREMIUM, TEMP PREMIUM FLEXIBLE, MULTISTRATUM FLEXIBLE, THERAPON, TRY-IN, BURNOUT, TRY-IN & BURNOUT by Zirkonzahn GmbH — Product Code EBG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 28, 2018
Date Received
March 5, 2018
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 Zirkonzahn GmbH

  • K232691 — Polibond (September 5, 2023)
  • K213722 — ICE Ceramics, ICE Stains, Fresco (December 14, 2022)
  • K203765 — ZIRKONZAHN.Implant-Planner, ZIRKONZAHN.Implant-Planner Practice, CAD/CAM STL Con (July 20, 2021)
  • K200676 — ABRO 1, RESITON GINGIVA, PRIME and THERAPON TRANSPA (July 8, 2020)
  • K190518 — Color Liquid, Vita Liquid (November 22, 2019)
  • K183304 — Prettau, ICE, Z-White zirconia blanks (April 4, 2019)
  • K181484 — Tecno Med, Tecno Med Mineral, Tecno Med Mineral Dentine, Tecno Med Mineral Tissu (June 18, 2018)
  • K151490 — PRETTAU ANTERIOR T0 (October 8, 2015)
  • K132230 — ICE ZIRKON TRANSLUZENT (November 5, 2014)
  • K061851 — ZIRKONZAHN ICE (September 29, 2006)

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)