Manufacturer registered with FDA
Good Sleep Co Pte Ltd
Singapore, Singapore. Lists 2 dental device types with FDA across 1 registered establishment, and holds 3 510(k) clearances as applicant.
- Device types listed
- 2
- Brands and models
- 6
- 510(k) clearances
- 32024–2025
- Markets registered in
- 22 registrations outside the US
- Establishments
- 1United States
510(k) clearances per year, 2007–2026
Registered in 2 markets
Where regulators' registries name Good Sleep Co Pte Ltd as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Good Sleep Co Pte Ltd | 3 clearances | 2024–2025 | Below |
| South Korea | MFDS | Manufacturer | GoodSleep co | 2 | 2025–2025 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Good Sleep Co Pte Ltd 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 | Maker | AveraHushd Pro AveraHUSHD PRO Z-LINKZ-LINK | 2024 |
| Orthodontic Space Preformed MaintainerDYT · Class 1 | Retainers, expanders & headgear | Maker | Hushd Pro GuardSplint | 2024 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Good Sleep Co Pte Ltd as the applicant, including filings under its other names.
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| GOOD SLEEP CO USA LLCFDA reg. 3031282374 | Grand Prairie, TX, United States | Manufacturer |
Other names on FDA records
Good Sleep Co. Usa LLC
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10090836). 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.