Not currently registered with FDA under this name
Glidewell Laboratories
Newport Beach, CA, United States. Named as applicant on 3 dental 510(k) clearances between 1997 and 2006. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 31997–2006
- Markets registered in
- 1United States
- Establishments
- 0—
510(k) clearances per year, 1990–2026
510(k) clearances
Clearances on which FDA names Glidewell Laboratories as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 15 Mar 2006 | K060104 | PRISMATIK CLINICAL ZIRCONIA | EIH Porcelain Powder |
| 3 Mar 2005 | K050144 | PRISMATIK CERAMIC | EIH Porcelain Powder |
| 18 Sep 1997 | K972424 | SILENTNITE | LRK Anti-Snoring Device |
Some of these clearances are listed with FDA today by another company: Prismatik Dentalcraft, Inc. (1).
Sources
FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record of the most recent filing, which can be a US agent.