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510(k) K234089

DNA Appliance by Vivos Therapeutics — Product Code LRK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 16, 2024
Date Received
December 22, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Anti-Snoring
Device Class
Class II
Regulation Number
872.5570
Review Panel
DE
Submission Type

Other clearances by Vivos Therapeutics

  • K230947 — C.A.R.E. Appliance (DNA, mRNA, mmRNA) (November 28, 2023)
  • K222872 — DNA Appliance (December 30, 2022)

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  • K251628 — Mandibular Advancement Device L07 (October 22, 2025)