Data / Medical devices / United States / Encore Laboratory
Encore Laboratory: FDA-registered device maker in Santa Ana, CA, United States, 4 510(k) clearances
Encore Laboratory is registered with the FDA (registration 3020749939) in Santa Ana, CA, United States. It lists 5 device types. The FDA files 4 510(k) clearances under its listings, the newest dated March 17, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3020749939
- Address
- 1520 Brookhollow DR Ste 38, Santa Ana, CA, United States, 92705
- Owner or operator
- enCore Laboratory (10083076)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- October 24, 2021
- Registered through
- 2026
- Brand names listed
- enCore Impression Material
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Impression Material For Fabrication Of Patient-Matched Mouthguards, Over-The-Counter | SHI | 2 | Manufacturer | accessdata.fda.gov |
| Material, Impression | ELW | 2 | Repackager or relabeler | accessdata.fda.gov |
| Mouthguard, Over-The-Counter | OBR | U | Manufacturer | accessdata.fda.gov |
| Mouthguard, Prescription | MQC | U | Manufacturer | accessdata.fda.gov |
| Tray, Impression, Preformed | EHY | 1 | Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 17, 2026 | K251926 | enCore Impression Material | SHI | Substantially Equivalent | Encore Guards | accessdata.fda.gov |
| November 25, 2025 | K252004 | enCore Night Guard | OBR | Substantially Equivalent | Encore Guards | accessdata.fda.gov |
| August 22, 2024 | K241369 | LIJIA Night Guard | MQC | Substantially Equivalent | Lijia, LLC | accessdata.fda.gov |
| September 16, 2009 | K092319 | STAR VPS, MODEL 80014-01, FIRST QUATER, MODEL 90649, FIRST HALF, MODEL 89387 | ELW | Substantially Equivalent | Danville Materials, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Tray, Impression, Preformed
- All makers of Mouthguard, Over-The-Counter
- All makers of Material, Impression
- All makers of Impression Material For Fabrication Of Patient-Matched Mouthguards, Over-The-Counter
- All makers of Mouthguard, Prescription
Updated March 17, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.