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Device, Anti-Snoring
FDA product code LRK · Class 2 · Dental
593
Registered devices
2,966
Adverse events
10
Recalls
216
510(k) clearances
Devices with this code
Blue + Hard/Soft — RESPIRE MEDICAL HOLDINGS LLCItus Mouthguardz — Shinrin-Yoku Traders LLCEMA — The Myerson Company LimitedSlow Wave — Slow Wave, Inc.EMA — The Myerson Company LimitedRespire Blue+ EF — Ortho Solutions, LCEmerald Herbst — Island Dental Lab Inc. DBA Emerald Dental LabEmerald Herbst — Island Dental Lab Inc. DBA Emerald Dental LabEMA Custom — The Myerson Company LimitedSML — SELANE PRODUCTS, INC.Vivos DNA — JOHN'S DENTAL LABORATORY INCEmerald Herbst — Island Dental Lab Inc. DBA Emerald Dental LabSomnoGuard SP Pro — Tomed GmbHEmerald Herbst — Island Dental Lab Inc. DBA Emerald Dental LabEmerald Herbst — Island Dental Lab Inc. DBA Emerald Dental LabEMA — The Myerson Company LimitedRest Assured — RANIR, LLCSomnoDent AVANT — SOMNOMED, INC.SomnoDent Air+ — SOMNOMED, INC.Dorsal Appliance — Ortho Solutions, LCEmerald Herbst — Island Dental Lab Inc. DBA Emerald Dental LabThe Slide® — BIOTEX, INC.Vivos mmRNA — FIVE STAR ORTHODONTIC LABORATORY & SUPPLY INCEmerald Herbst — Island Dental Lab Inc. DBA Emerald Dental Lab
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-04-27 | Prismatik Dentalcraft, Inc. | Due to device not having FDA Clearance |
| 2025-10-09 | Myofunctional Research Company USA | Due to firm mistakenly distributing product within the U.S. without FDA premarket clearance/approval. |
| 2022-05-23 | Dental Choice Holding Llc | The device was marketed and sold in the US without FDA clearance. |
| 2017-09-01 | Respire Medical | Potential for device breakage during use |
| 2017-09-01 | Respire Medical | Potential for device breakage during use |
| 2017-09-01 | Respire Medical | Potential for device breakage during use |
| 2017-09-01 | Respire Medical | Potential for device breakage during use |
| 2017-09-01 | Respire Medical | Potential for device breakage during use |
| 2009-07-27 | Medtronic Xomed, Inc. | Medtronic Xomed, Inc. is recalling the Repose Bone Screw System product and Bone Screw product due to improper labeling. The labeling for the Repose System was |
| 2009-07-27 | Medtronic Xomed, Inc. | Medtronic Xomed, Inc. is recalling the Repose Bone Screw System product and Bone Screw product due to improper labeling. The labeling for the Repose System was |
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