Data / Medical devices / United States / Sleepcare, LLC
Sleepcare, LLC: FDA-registered device maker in Los Angeles, CA, United States, 4 510(k) clearances
Sleepcare, LLC is registered with the FDA (registration 3031288631) in Los Angeles, CA, United States. It lists 5 device types. The FDA files 4 510(k) clearances under its listings, the newest dated October 20, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3031288631
- Address
- 11858 La Grange Ave Fl 2, Los Angeles, CA, United States, 90025
- Owner or operator
- Sleepcare, LLC (10090819)
- Roles
- Repackager or relabeler, Specification developer
- First device listed
- May 21, 2024
- Registered through
- 2027
- Brand names listed
- Daybreak Device Classic, Daybreak Device Neo, Daybreak Impression Material Kit, Daybreak Impression Material OTC, Rise and Bite
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Anti-Snoring | LRK | 2 | Repackager or relabeler | accessdata.fda.gov |
| Device, Jaw Repositioning | LQZ | 2 | Repackager or relabeler | accessdata.fda.gov |
| Impression Material For Fabrication Of Patient-Matched Mouthguards, Over-The-Counter | SHI | 2 | Specification developer | accessdata.fda.gov |
| Material, Impression | ELW | 2 | Repackager or relabeler | accessdata.fda.gov |
| Positioner, Tooth, Preformed | KMY | 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 |
|---|---|---|---|---|---|---|
| October 20, 2026 | K262421 | Daybreak Impression Material | SHI | Substantially Equivalent | Sleepcare, LLC | accessdata.fda.gov |
| December 18, 2025 | K252976 | Park Dental Nylon MAD | LRK | Substantially Equivalent | Park Dental Research Corp. | accessdata.fda.gov |
| October 8, 2020 | K201483 | Impression Material | ELW | Substantially Equivalent | Zhengzhou Huaer Electro Optics Technology Co., Ltd. | accessdata.fda.gov |
| July 17, 2019 | K183270 | Silent Nite sl | LRK | Substantially Equivalent | Prismatik Dentalcraft, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Material, Impression
- All makers of Impression Material For Fabrication Of Patient-Matched Mouthguards, Over-The-Counter
- All makers of Device, Jaw Repositioning
- All makers of Device, Anti-Snoring
- All makers of Positioner, Tooth, Preformed
Updated October 20, 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.