Device, Anti-Snoring
Regulation 872.5570
14510(k)s in 12 months (217 all time)
2recalls in 12 months (10 all time)
6recalls that name a 510(k)
Top companies in LRK
| Company | 510(k)s | Recalls |
|---|---|---|
| Somnomed, Inc. | 9 | 0 |
| Respire Medical | 3 | 5 |
| Sleeping Well, LLC | 6 | 0 |
| Prismatik Dentalcraft, Inc. | 4 | 1 |
| Airway Management, Inc. | 4 | 0 |
| Allen J. Moses, Dds, Ltd. | 4 | 0 |
| Always More Marketing | 4 | 0 |
| Medtronic Xomed, Inc. | 2 | 2 |
| Oventus Manufacturing Pty, Ltd. | 4 | 0 |
| Dental Imagineers, LLC | 3 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 21, 2026 | Prismatik Dentalcraft, Inc. Brand Name: Silent Nite
Product Name: Silent Nite Sleep Appliance
Model/Catalog Number: SILNT
Product Description: Silent Nite Sleep Appliance is a mandibular advancement device (MAD) intended to t Open, Classified |
LRK | K183270 K972424 |
| Dec 18, 2025 | Myofunctional Research Company USA Myosa for Kids
KS1 REF MyOSAKS1_Sb/Sp/Mb/Mp/Lb/Lc
KS2 REF MyOSAKS2_Sb/Sc/Mb/Mc/Mp/Lb/Lc
Myosa for Kids is a mouthguard in 3 different sizes (sm, med, lg) that can be used in children ages 3-15 to
ad Open, Classified |
LRK | None listed |
| May 23, 2022 | Dental Choice Holding Llc CustMbite, Model Number CBT-SRS-UL Open, Classified |
LRK | None listed |
| May 29, 2018 | Respire Medical Respire Pink H/S Oral Sleep Apnea Device Terminated |
LRK | None listed |
| May 29, 2018 | Respire Medical Respire Pink H/S Oral Sleep Apnea Device Terminated |
LRK | None listed |
| May 29, 2018 | Respire Medical Respire Pink+ Hard Oral Sleep Apnea Device Terminated |
LRK | K150572 |
| May 29, 2018 | Respire Medical Respire Pink+ Hard/Soft Oral Sleep Apnea Device Terminated |
LRK | K150572 |
| May 29, 2018 | Respire Medical Respire Pink Series EF+ Oral Sleep Apnea Device. Terminated |
LRK | K150572 |
| Dec 15, 2009 | Medtronic Xomed, Inc. Repose G2 Bone Screw, Sterile, REF 76310200, Lot # 62450200.
Distributed by Medtronic Xomed, Inc., Jacksonville, Florida 32216 U.S.A. Terminated |
LRK | K981677 |
| Dec 15, 2009 | Medtronic Xomed, Inc. Repose G2 Bone Screw System, Sterile, REF 76353200; Lot # 62450300.
Distributed by Medtronic Xomed, Inc. Jacksonville, Florida 32216 U.S.A.
The Repose G@ Bone Screw System is composed of the Repose Terminated |
LRK | K981677 |
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