Home › Device types › LRK
Device, Anti-Snoring
FDA product code LRK · Class 2 · Dental
575
Registered devices
2,628
Adverse events
10
Recalls
214
510(k) clearances
Devices with this code
SomnoGuard AP Pro — Tomed GmbHEMA — The Myerson Company LimitedItus Mouthguardz — Shinrin-Yoku Traders LLCEmerald Herbst — Island Dental Lab Inc. DBA Emerald Dental LabRemotely controlled mandibular positioner (MATRx) — Zephyr Sleep Technologies IncClearDream — KELLER LABORATORIES, INC.EMA — The Myerson Company LimitedO2Vent T — OVENTUS MANUFACTURING PTY LTDApnea Guard — ADVANCED BRAIN MONITORING, INC.Emerald Herbst — Island Dental Lab Inc. DBA Emerald Dental LabEmerald Herbst — Island Dental Lab Inc. DBA Emerald Dental LabEmerald Herbst — Island Dental Lab Inc. DBA Emerald Dental LabEmerald Herbst — Island Dental Lab Inc. DBA Emerald Dental LabMyTAP oral appliance — AIRWAY TECHNOLOGIES, LLCNAPA (Nocturnal Airway Patency Appliance) — JOHN'S DENTAL LABORATORY INCBlue Series - EF — RESPIRE MEDICAL HOLDINGS LLCThe Moses TM Appliance — Modern Dental Laboratory (DG) Co., Ltd.Zyppah — A.M.A. PLASTICSBanded Herbst-Rpe Remov Lower — Great Lakes Dental Technologies, Ltd.EMA — The Myerson Company LimitedApnea Guard — ADVANCED BRAIN MONITORING, INC.Respire Blue+ EF — Ortho Solutions, LCEmerald Herbst — Island Dental Lab Inc. DBA Emerald Dental LabEMA — The Myerson Company Limited
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 |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.