Medical Device Manufacturer · US , Silver Creek , NY

Zirkonzahn GmbH - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 2006

Recent clearances: TEMP BASIC, TEMP PREMIUM, TEMP PREMIUM FLEXIBLE, MULTISTRATUM FLEXIBLE, THERAPON, TRY-IN, BURNOUT, TRY-IN & BURNOUT, PRETTAU ANTERIOR T0, ZIRKONZAHN ICE

View 3 510(k) Devices ↓

3

Total

3

Cleared

0

Denied

FDA 510(k) Regulatory Record - Zirkonzahn GmbH Dental ✕

3 devices

1-3 of 3

Cleared Jun 28, 2018

TEMP BASIC, TEMP PREMIUM, TEMP PREMIUM FLEXIBLE, MULTISTRATUM FLEXIBLE,...

Cleared Oct 08, 2015

PRETTAU ANTERIOR T0

Cleared Sep 29, 2006

Data Source

Sourced from the FDA 510(k) public files . 176,325 total devices indexed.

Last updated: Jun 09, 2026