Manufacturer registered with FDA
enCore Laboratory
Santa Ana, CA, United States. Lists 3 dental device types with FDA across 1 registered establishment.
- Device types listed
- 3
- Brands and models
- 1
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1United States
Devices listed with FDA
What enCore Laboratory currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Preformed Impression TrayEHY · Class 1 | Impression trays | Lister | — | 2021 |
| Impression MaterialELW · Class 2 | Impression materials | Lister | — | 2025 |
| Over-the-Counter Impression Material for Fabrication of Patient-Matched MouthguardsSHI · Class 2 | — | Maker | enCore Impression Material | 2026 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
enCore Laboratory lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Encore Guards (1), Danville Materials, LLC (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 17 Mar 2026 | K251926 | enCore Impression Material | Encore Guards | SHI Over-the-Counter Impression Material for Fabrication of Patient-Matched Mouthguards |
| 16 Sep 2009 | K092319 | STAR VPS, MODEL 80014-01, FIRST QUATER, MODEL 90649, FIRST HALF, MODEL 89387 | Danville Materials, LLC | ELW Impression Material |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| ENCORE LABORATORYFDA reg. 3020749939 | Santa Ana, CA, United States | Manufacturer, Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10083076). 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.