TEMP BASIC, TEMP PREMIUM, TEMP PREMIUM FLEXIBLE, MULTISTRATUM FLEXIBLE, THERAPON, TRY-IN, BURNOUT, TRY-IN & BURNOUT— 510(k) K180562

Name: FDA 510(k) clearance K180562
Creator: U.S. Food and Drug Administration
Published: 2018-06-28

Substantially Equivalent

Zirkonzahn GmbH

FDA 510(k) clearance K180562 for TEMP BASIC, TEMP PREMIUM, TEMP PREMIUM FLEXIBLE, MULTISTRATUM FLEXIBLE, THERAPON, TRY-IN, BURNOUT, TRY-IN & BURNOUT, Substantially Equivalent on 2018-06-28. Applicant: Zirkonzahn GmbH. Device class: 2.

Clearance details

Applicant: Zirkonzahn GmbH
Product code: Code EBG
Device class: Class 2
Regulation: 21 CFR 872.3770
Advisory panel: Dental
Date received: 2018-03-05
Decision date: 2018-06-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gais, IT

Download summary PDF View on FDA.gov ↗

Recent devices under product code EBG

view all

K261261 — Dura-Arch2026-04-17
K253380 — FLNT Base and FLNT Temp2026-03-02
K251271 — TempFIT Temporary Crown and Bridge Resin2025-06-23
K243370 — DentaTOOTH2025-05-05
K243621 — Evoblock, Perléon2025-04-22

More clearances from Zirkonzahn GmbH

view all

K151490 — PRETTAU ANTERIOR T02015-10-08
K061851 — ZIRKONZAHN ICE2006-09-29

Data sourced from openFDA. This site is unofficial and independent of the FDA.