Anti Snoring Mouthpiece (L09-BB, L09-PP, L09-TB, L09-BT, L09-TP, L09-PT, L09-TT)— 510(k) K262104
Substantially EquivalentRam.Shaw Pte., Ltd.
FDA 510(k) clearance K262104 for Anti Snoring Mouthpiece (L09-BB, L09-PP, L09-TB, L09-BT, L09-TP, L09-PT, L09-TT), Substantially Equivalent on 2026-08-27. Applicant: Ram.Shaw Pte., Ltd.. Device class: 2.
Summary
Ram.Shaw's Anti Snoring Mouthpiece lists seven models: L09-BB, L09-PP, L09-TB, L09-BT, L09-TP, L09-PT, and L09-TT. The product code is LRK, anti-snoring devices, and the record doesn't say how the models differ.
Class II, 21 CFR 872.5570. Dental is both the classification panel and the review panel. It came in as a Special 510(k).
Ram.Shaw filed from Singapore. The decision came 65 calendar days after receipt (June 23 to August 27, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- Ram.Shaw Pte., Ltd.
- Product code
- Product code LRK
- Device class
- Class 2
- Regulation
- 21 CFR 872.5570
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Singapore, SG
Recent devices under product code LRK
view allMore clearances from Ram.Shaw Pte., Ltd.
view allAdverse events under product code LRK
product code LRK- Injury
- 246
- Malfunction
- 1,044
- Total
- 1,290
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.