Data / Medical devices / United States / Owl Dental
Owl Dental: FDA-registered device maker in San Leandro, CA, United States, 2 510(k) clearances
Owl Dental is registered with the FDA (registration 3030268763) in San Leandro, CA, United States. It lists 5 device types. The FDA files 2 510(k) clearances under its listings, the newest dated February 26, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3030268763
- Address
- 345 Estudillo Ave # 211, San Leandro, CA, United States, 94577
- Owner or operator
- Owl Dental (10095355)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- March 3, 2026
- Registered through
- 2026
- Brand names listed
- Owl Impression Material, Owl Impression Tray, Owl Night Guard
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Material, Impression | ELW | 2 | Repackager or relabeler | accessdata.fda.gov |
| Mouthguard, Migraine/Tension Headache | OCO | U | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| February 26, 2026 | K253641 | Owl Night Guard | OBR | Substantially Equivalent | Owl Dental Lab, Inc. | accessdata.fda.gov |
| May 28, 2014 | K133071 | ELASTIC IMPRESSION MATERIAL | ELW | Substantially Equivalent | Rizhao Huge Dental Industry Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Tray, Impression, Preformed
- All makers of Mouthguard, Migraine/Tension Headache
- All makers of Mouthguard, Over-The-Counter
- All makers of Mouthguard, Prescription
- All makers of Material, Impression
Updated February 26, 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.