BACKGROUNDRegulatoryTier 1
FDA 510(k) K262104: Anti Snoring Mouthpiece (L09-BB, L09-PP, L09-TB, L09-BT, L09-TP, L09-PT, L09-TT)
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 offering sleep-apnea or snoring appliances now have another 510(k)-cleared mandibular advancement device option, which may influence material purchasing decisions and patient counseling.
Key points
- Product codes LRK (anti-snoring devices) fall under 21 CFR 872.5570 and are Class II, requiring prescription labeling.
- Six model variants (L09-BB through L09-TT) cleared via substantial equivalence; none described as novel technology.
- Clearance issued to Singapore-based Ram.Shaw Pte., Ltd., expanding the supplier pool for U.S. dental labs and DME providers.
- Dentists prescribing oral appliances must still verify fit, protrusive range, and titration protocols regardless of 510(k) status.
Who should care
OwnerSpecialist
Read the original on openFDA Dental Devices
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