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510(k) K200676

ABRO 1, RESITON GINGIVA, PRIME and THERAPON TRANSPA by Zirkonzahn Srl — Product Code EBG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 8, 2020
Date Received
March 16, 2020
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 Srl

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  • K190518 — Color Liquid, Vita Liquid (November 22, 2019)
  • K183304 — Prettau, ICE, Z-White zirconia blanks (April 4, 2019)
  • K180562 — TEMP BASIC, TEMP PREMIUM, TEMP PREMIUM FLEXIBLE, MULTISTRATUM FLEXIBLE, THERAPON (June 28, 2018)
  • 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)
  • K242559 — Digital Temp (November 26, 2024)
  • K231859 — PrimmaArt (November 26, 2024)
  • K240538 — Premium Teeth Resin (July 19, 2024)
  • K241226 — Fixtemp® C&B 4:1 (May 31, 2024)