Data / Medical devices / United States / Vivos Therapeutics INC.
Vivos Therapeutics INC.: FDA-registered device maker in Murray, KY, United States, 8 510(k) clearances
Vivos Therapeutics INC. is registered with the FDA (registration 3022315836) in Murray, KY, United States. It lists 9 device types. The FDA files 8 510(k) clearances under its listings, the newest dated December 30, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3022315836
- Address
- 300 S 5th Street, Murray, KY, United States, 42071
- Owner or operator
- Vivos Therapeutics, Inc. (10054340)
- Roles
- Repackager or relabeler, Specification developer
- First device listed
- March 9, 2017
- Registered through
- 2026
- Brand names listed
- DNA, Facialblocks, SleepImage System, V-Starter Kids, V-Starter Kids; V-Starter PreTeen; Vivos Grow (VG); Vivos Guide System; Vivos Way (VW), V-Starter PreTeen, Vivos DNA Appliance, Vivos EMA Now and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Clamp, Wire, Orthodontic | ECN | 1 | Specification developer | accessdata.fda.gov |
| Device, Anti-Snoring | LRK | 2 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Device, Jaw Repositioning | LQZ | 2 | Specification developer | accessdata.fda.gov |
| Dilator, Nasal | LWF | 1 | Specification developer | accessdata.fda.gov |
| Mouthguard, Prescription | MQC | U | Specification developer | accessdata.fda.gov |
| Positioner, Tooth, Preformed | KMY | 1 | Specification developer | accessdata.fda.gov |
| Retainer, Screw Expansion, Orthodontic | DYJ | 1 | Specification developer | accessdata.fda.gov |
| Ventilatory Effort Recorder | MNR | 2 | Repackager or relabeler | accessdata.fda.gov |
| Wire, Orthodontic | DZC | 1 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 30, 2022 | K222872 | DNA Appliance | LRK | Substantially Equivalent | Vivos Therapeutics, Inc. | accessdata.fda.gov |
| August 19, 2021 | K210203 | mmRNA appliance | LRK | Substantially Equivalent | Vivos Therapeutics, Inc. (Formerly Vivos Biotechnologies, I) | accessdata.fda.gov |
| March 10, 2021 | K203606 | Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep Elastic Mandibular Advancement (EMA) | LRK | Substantially Equivalent | Meris Investment Group | accessdata.fda.gov |
| January 28, 2020 | K192581 | The NightBlocks Appliance | LQZ | Substantially Equivalent | Advanced Facialdontics, LLC | accessdata.fda.gov |
| August 14, 2019 | K182618 | SleepImage System | MNR | Substantially Equivalent | Mycardio, LLC Dba Sleepimage. | accessdata.fda.gov |
| July 17, 2019 | K182820 | The POD | MQC | Substantially Equivalent | Advanced Facialdontics, LLC | accessdata.fda.gov |
| May 8, 2014 | K130067 | MRNA APPLIANCE | LRK | Substantially Equivalent | Biomodeling Solutions, Lls | accessdata.fda.gov |
| September 29, 1997 | K971794 | ELASTIC MANDIBULAR ADVANCEMENT (EMA) APPLIANCE | LRK | Substantially Equivalent | Frantz Design, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Device, Anti-Snoring
- All makers of Device, Jaw Repositioning
- All makers of Retainer, Screw Expansion, Orthodontic
- All makers of Positioner, Tooth, Preformed
- All makers of Wire, Orthodontic
- All makers of Dilator, Nasal
Updated December 30, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.