Manufacturer registered with FDA
Vivos Therapeutics, Inc.
Murray, KY, United States. Lists 6 dental device types with FDA across 1 registered establishment, and holds 3 510(k) clearances as applicant.
- Device types listed
- 6
- Brands and models
- 18
- 510(k) clearances
- 32022–2024
- Markets registered in
- 24 registrations outside the US
- Establishments
- 1United States
510(k) clearances per year, 2007–2026
Registered in 2 markets
Where regulators' registries name Vivos Therapeutics, Inc. 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 | Vivos Therapeutics, Inc. | 3 clearances | 2022–2024 | Below |
| Australia | TGA | Manufacturer | Vivos Therapeutics Inc | 4 | 2024–2024 | 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 Vivos Therapeutics, Inc. 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 | DNAVivos EMA NowVivos mmRNA ApplianceVivos mRNA ApplianceVivos VersaVivos Vida Sleep | 2017 |
| Jaw Repositioning DeviceLQZ · Class 2 | Anti-snoring & jaw-repositioning devices | Maker | DNAVivos mmRNA ApplianceVivos Vida Sleep | 2021 |
| Orthodontic Screw Expansion RetainerDYJ · Class 1 | Retainers, expanders & headgear | Maker | FacialblocksV-Starter Kids; V-Starter PreTeen; Vivos Grow (VG); Vivos Guide System; Vivos Way (VW) | 2018 |
| Orthodontic WireDZC · Class 1 | Orthodontic wires & bands | Maker | Vivos DNA Appliance | 2017 |
| Orthodontic Wire ClampECN · Class 1 | — | Maker | Vivos PEx | 2023 |
| Preformed Tooth PositionerKMY · Class 1 | Retainers, expanders & headgear | Maker | V-Starter KidsV-Starter PreTeenVivos Grow (VG)Vivos Guide SystemVivos Way (VW) | 2017 |
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 Vivos Therapeutics, Inc. as the applicant.
Also lists devices cleared under other names
Vivos Therapeutics, Inc. 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: Vivos Therapeutics, Inc. (Formerly Vivos Biotechnologies, I) (1), Meris Investment Group (1), Advanced Facialdontics, LLC (1), Biomodeling Solutions, Lls (1), Frantz Design, Inc. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 19 Aug 2021 | K210203 | mmRNA appliance | Vivos Therapeutics, Inc. (Formerly Vivos Biotechnologies, I) | LRK Anti-Snoring Device |
| 10 Mar 2021 | K203606 | Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep Elastic Mandibular Advancement (EMA) | Meris Investment Group | LRK Anti-Snoring Device |
| 28 Jan 2020 | K192581 | The NightBlocks Appliance | Advanced Facialdontics, LLC | LQZ Jaw Repositioning Device |
| 8 May 2014 | K130067 | MRNA APPLIANCE | Biomodeling Solutions, Lls | LRK Anti-Snoring Device |
| 29 Sep 1997 | K971794 | ELASTIC MANDIBULAR ADVANCEMENT (EMA) APPLIANCE | Frantz Design, Inc. | LRK Anti-Snoring Device |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| Vivos Therapeutics INC.FDA reg. 3022315836 | Murray, KY, United States | Repacker / relabeler, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10054340). 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.