Class Class II
DNA Appliance (K222872)
Description
DNA Appliance by Vivos Therapeutics, Inc., an FDA 510(k) cleared dental device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK222872
Clearance Date2022-12-30
Clearance TypeTraditional
Product CodeLRK
Regulation Number872.5570
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K222872
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. DNA Appliance (K222872) cites 2 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K210203 | mmRNA appliance | Vivos Therapeutics, Inc. (Formerly ... | 2021 |
| K130067 | MRNA APPLIANCE | Biomodeling Solutions, Lls | 2014 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K230947 | C.A.R.E. Appliance (DNA, mRNA, mmRNA) | Vivos Therapeutics, Inc. | 2023 |
Trace the full predicate network for K222872
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.