---
schema_version: "secwatch.filing_event.v1"
accession: "0001493152-24-036942"
form_type: "8-K"
ticker: "VVOS"
cik: "0001716166"
company_name: "Vivos Therapeutics, Inc."
filed_at: "2024-09-18T23:59:59+00:00"
generated_at: "2026-05-31T03:59:10.206489+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Vivos Therapeutics receives first FDA 510(k) clearance for oral device to treat pediatric OSA

## Summary
- FDA cleared Vivos' DNA appliance to treat moderate to severe OSA and snoring in children aged 6–17.
- Up to 10.1 million U.S. children estimated to suffer from pediatric OSA; current standard is adenotonsillectomy.
- Clinical study (n=48) showed 62.7% improvement in AHI, 58% snoring reduction, no safety concerns.
- Company plans to leverage clearance via new marketing & distribution alliances with medical sleep providers.
- Believed to be first-ever FDA clearance of an oral medical device for pediatric OSA treatment.

## SEC filing metadata
- accession: 0001493152-24-036942
- form_type: 8-K
- ticker: VVOS
- cik: 0001716166
- company_name: Vivos Therapeutics, Inc.
- filed_at: 2024-09-18T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1716166/000149315224036942/0001493152-24-036942-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1716166/000149315224036942/form8-k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001493152-24-036942
- JSON: https://secwatch.observer/filing/0001493152-24-036942.json
- Plain text: https://secwatch.observer/filing/0001493152-24-036942.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.