Manufacturer registered with FDA
Sleepcare, LLC
Los Angeles, CA, United States. Lists 5 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 5
- Brands and models
- 6
- 510(k) clearances
- 12026–2026
- Markets registered in
- 1United States
- Establishments
- 1United States
510(k) clearances per year, 2007–2026
Devices listed with FDA
What Sleepcare, LLC currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Anti-Snoring DeviceLRK · Class 2 | Anti-snoring & jaw-repositioning devices | Lister | Daybreak Device ClassicDaybreak Device Neo | 2024 |
| Impression MaterialELW · Class 2 | Impression materials | Lister | Daybreak Impression Material Kit | 2026 |
| Preformed Tooth PositionerKMY · Class 1 | Retainers, expanders & headgear | Lister | Rise and Bite | 2026 |
| Jaw Repositioning DeviceLQZ · Class 2 | Anti-snoring & jaw-repositioning devices | Lister | Daybreak Device Neo | 2026 |
| Over-the-Counter Impression Material for Fabrication of Patient-Matched MouthguardsSHI · Class 2 | — | Maker | Daybreak Impression Material OTC | 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
Sleepcare, LLC 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: Park Dental Research Corp (1), Zhengzhou Huaer Electro-optics Technology Co., Ltd. (1), Prismatik Dentalcraft, Inc. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 18 Dec 2025 | K252976 | Park Dental Nylon MAD | Park Dental Research Corp | LRK Anti-Snoring Device |
| 8 Oct 2020 | K201483 | Impression Material | Zhengzhou Huaer Electro-optics Technology Co., Ltd. | ELW Impression Material |
| 17 Jul 2019 | K183270 | Silent Nite sl | Prismatik Dentalcraft, Inc. | LRK Anti-Snoring Device |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| SLEEPCARE, LLCFDA reg. 3031288631 | Los Angeles, CA, United States | Repacker / relabeler, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10090819). 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.