PRETTAU ANTERIOR T0— 510(k) K151490

Substantially Equivalent

Zirkonzahn GmbH

FDA 510(k) clearance K151490 for PRETTAU ANTERIOR T0, Substantially Equivalent on 2015-10-08. Applicant: Zirkonzahn GmbH. Device class: 2.

Clearance details

Applicant: Zirkonzahn GmbH
Product code: Code EIH
Device class: Class 2
Regulation: 21 CFR 872.6660
Advisory panel: Dental
Date received: 2015-06-03
Decision date: 2015-10-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gais, IT

Download summary PDF View on FDA.gov ↗

Recent devices under product code EIH

K262074 — Any-Zircos2026-08-21
K262239 — Obsidian® Press Over Zirconia2026-07-30
K261046 — Dental Zirconia Blank & Coloring Liquid2026-07-17
K262195 — Dandy Ceramic Stain and Glaze2026-06-30
K260918 — Zolid Lunaris2026-06-29

More clearances from Zirkonzahn GmbH

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