FDA 510(k) K261912: SnØreNegatØr
Summary & scoring by The Bell Brief (Dr. Jennifer Bell) using the Drill-Down Protocol (Drill-Down Score) — not the original publisher.
Why it matters for dental
Dental practices that fabricate or dispense custom anti-snoring appliances now have a newly-cleared Class II predicate device (SnØreNegatØr) they can reference for 510(k) submissions, potentially streamlining regulatory pathways for similar oral appliances.
Key points
- Device classified under 21 CFR 872.5570 (intraoral devices for snoring/sleep-disordered breathing) with product code LRK, confirming dental regulatory oversight.
- Traditional 510(k) clearance granted on substantial equivalence, meaning new oral appliances can cite K261912 as a predicate to reduce review time and cost.
- Targeted to dentists, sleep-medicine dentists, and DSOs that offer mandibular advancement or tongue-retaining devices for snoring.
- Does not alter clinical standards of care or payer coverage; practices must still comply with state dental-board rules on sleep-apnea appliance therapy.
Who should care
Read the original on openFDA Dental Devices
Full reporting and any paywall content live on accessdata.fda.gov. We summarize and score; we do not republish.
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