Not currently registered with FDA under this name
Enamelite, LLC
Austin, TX, United States. Named as applicant on 2 dental 510(k) clearances between 2003 and 2009. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 22003–2009
- Markets registered in
- 1United States
- Establishments
- 0—
510(k) clearances per year, 2000–2026
510(k) clearances
Clearances on which FDA names Enamelite, LLC as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 22 Dec 2009 | K093019 | ENAMELITE ACRYSEAL SPRAY SEALANT | EBD Resin Filling Material Coating |
| 27 Mar 2003 | K030859 | NOVA CERAMIC SPRAY GLAZE AND TRU-PAQUE, OPAQUE PORCELAIN | EIH Porcelain Powder |
Some of these clearances are listed with FDA today by another company: Prismatik Dentalcraft, Inc. (1), Keystone Industries (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.