Medical Device Manufacturer · US , Newport Beach , CA

Glidewell Laboratories - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 1997

Recent clearances: PRISMATIK CLINICAL ZIRCONIA, PRISMATIK CERAMIC, SILENTNITE

View 3 510(k) Devices ↓

3

Total

3

Cleared

0

Denied

FDA 510(k) Regulatory Record - Glidewell Laboratories Dental ✕

3 devices

1-3 of 3

Cleared Mar 15, 2006

PRISMATIK CLINICAL ZIRCONIA

Cleared Mar 03, 2005

PRISMATIK CERAMIC

Cleared Sep 18, 1997

Data Source

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

Last updated: Sep 07, 2026