# Sleepcare, LLC (repackager or relabeler, Los Angeles, CA): 2 new FDA device listings, incl. positioner, tooth, preformed

**Score:** 50/100

| Field | Value |
|---|---|
| Establishment | Sleepcare, LLC |
| Role | Repackager or relabeler |
| Establishment types | Repack or Relabel Medical Device |
| Location | Los Angeles, CA, US |
| New listings | 2 |
| Devices | Positioner, Tooth, Preformed; Material, Impression |
| Product codes | KMY, ELW |
| Device classes | Class I, Class II |
| Medical specialties | Dental |
| Brand names | Rise and Bite; Daybreak Impression Material Kit |
| First new listing | 2026-05-01 |
| Latest new listing | 2026-06-18 |
| FDA registration number | 3031288631 |
| Registration expires | 2026-12-31 |

## Why this score
- Class II or III devices: QMS and regulatory demands.
- U.S. establishment.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-10-28T20:51:27.468Z.
From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.