Manufacturer registered with FDA
Sleeping Well, LLC
Shelburne, VT, United States. Lists 2 dental device types with FDA across 1 registered establishment, and holds 6 510(k) clearances as applicant.
- Device types listed
- 2
- Brands and models
- 6
- 510(k) clearances
- 62009–2022
- Markets registered in
- 35 registrations outside the US
- Establishments
- 1United States
510(k) clearances per year, 2000–2026
Registered in 3 markets
Where regulators' registries name Sleeping Well, LLC 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 | Sleeping Well, LLC | 6 clearances | 2009–2022 | Below |
| Taiwan | TFDA | Manufacturer | SLEEPING WELL, LLC.SLEEPING WELL, LLC | 4 | 2013–2019 | Pure Global AI |
| Australia | TGA | Manufacturer | Sleeping Well LLC | 1 | 2026–2026 | 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 Sleeping Well, 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 | Maker | ZQuietZQuiet Advance Anti-Snoring MouthpieceZQuiet Pro-FlexZQuiet Pro-PlusZQuiet-S.A. | 2010 |
| Over the Counter Denture CleanserEFT · Class 1 | Denture cleansers & adhesives | Lister | ZQuiet Clean | 2025 |
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 Sleeping Well, LLC as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 15 Jun 2022 | K213088 | ZQuiet Advance | LRK Anti-Snoring Device |
| 12 Jun 2018 | K180124 | ZQuiet | LRK Anti-Snoring Device |
| 25 Jul 2014 | K140777 | ZQUIET-SA | LRK Anti-Snoring Device |
| 7 Dec 2012 | K122475 | ZQUIET PRO-PLUS | LRK Anti-Snoring Device |
| 22 Jun 2010 | K093407 | ZQUIET MOUTHPIECE | LRK Anti-Snoring Device |
| 10 Mar 2009 | K090503 | ZQUIET MOUTHPIECE | LRK Anti-Snoring Device |
Some of these clearances are listed with FDA today by another company: AdvanTech Plastics, LLC (1).
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| SLEEPING WELL, LLCFDA reg. 3008797926 | Shelburne, VT, United States | Repacker / relabeler, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10034704). 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.