Device, Anti-snoring
Dental · 21 CFR 872.5570
Recent MDR events
2,628 adverse event reports on file
- Silent NiteJul 31, 2026MalfunctionPrismatik Dentalcraft, Inc.3011649314-2026-01174
- Silent NiteJul 31, 2026MalfunctionPrismatik Dentalcraft, Inc.3011649314-2026-01175
- Silent NiteJul 31, 2026MalfunctionPrismatik Dentalcraft, Inc.3011649314-2026-01206
- Silent Nite 3D One PieceJul 30, 2026MalfunctionPrismatik Dentalcraft, Inc.3011649314-2026-01145
- Silent NiteJul 30, 2026MalfunctionPrismatik Dentalcraft, Inc.3011649314-2026-01148
- Silent NiteJul 30, 2026MalfunctionPrismatik Dentalcraft, Inc.3011649314-2026-01152
- Silent Nite 3D One PieceJul 29, 2026MalfunctionPrismatik Dentalcraft, Inc.3011649314-2026-01130
- Silent NiteJul 29, 2026MalfunctionPrismatik Dentalcraft, Inc.3011649314-2026-01103
- Silent NiteJul 29, 2026InjuryPrismatik Dentalcraft, Inc.3011649314-2026-01146
- Daybreak Device ClassicJul 29, 2026MalfunctionPrismatik Dentalcraft, Inc.3031288631-2026-00101
Event type breakdown
Recalls
10 recall events for this product code
- Prismatik Dentalcraft, Inc.Open, ClassifiedJul 21, 2026
Brand Name: Silent Nite
Due to device not having FDA Clearance
Z-2769-2026 · View FDA record ↗ - Myofunctional Research Company USAOpen, ClassifiedDec 18, 2025
Myosa for Kids
Due to firm mistakenly distributing product within the U.S. without FDA premarket clearance/approval.
Z-0956-2026 · View FDA record ↗ - Respire MedicalTerminatedMay 29, 2018
Respire Pink Series EF+ Oral Sleep Apnea Device.
Potential for device breakage during use
Z-1947-2018 · View FDA record ↗ - Respire MedicalTerminatedMay 29, 2018
Respire Pink+ Hard/Soft Oral Sleep Apnea Device
Potential for device breakage during use
Z-1948-2018 · View FDA record ↗ - Respire MedicalTerminatedMay 29, 2018
Respire Pink+ Hard Oral Sleep Apnea Device
Potential for device breakage during use
Z-1949-2018 · View FDA record ↗ - Respire MedicalTerminatedMay 29, 2018
Respire Pink H/S Oral Sleep Apnea Device
Potential for device breakage during use
Z-1950-2018 · View FDA record ↗ - Respire MedicalTerminatedMay 29, 2018
Respire Pink H/S Oral Sleep Apnea Device
Potential for device breakage during use
Z-1951-2018 · View FDA record ↗ - Medtronic Xomed, Inc.TerminatedDec 15, 2009
Repose G2 Bone Screw System, Sterile, REF 76353200; Lot # 62450300.
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 inadvertently placed on the Repose Screw and vice versa.
Z-0535-2010 · View FDA record ↗ - Medtronic Xomed, Inc.TerminatedDec 15, 2009
Repose G2 Bone Screw, Sterile, REF 76310200, Lot # 62450200.
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 inadvertently placed on the Repose Screw and vice versa.
Z-0536-2010 · View FDA record ↗ - Dental Choice Holding LlcOpen, ClassifiedUnknown
CustMbite, Model Number CBT-SRS-UL
The device was marketed and sold in the US without FDA clearance.
Z-1494-2022 · View FDA record ↗
Registered firms
271 firms currently registered for this product code
Prismatik Dentalcraft, Inc.
Irvine, CA, US
Great Lakes Dental Technologies, Ltd.
TONAWANDA, NY, US
Modern Dental International Trading Limited
Hong Kong, HK
Crane Dental Laboratory
Rochester, NY, US
Modern Dental Laboratory (dg) Co., Ltd.
Dongguan Guangdong, CN
Somnomed, Ltd.
CROWS NEST New South Wales, AU
Braebon Medical Corp.
KANATA Ontario, CA
Gergens Orthodontic Lab
Phoenix, AZ, US
Ceva Logistics Netherlands Bv (venray)
Oostrum Limburgh, NL
Ortho Solutions Lc
Lake Saint Louis, MO, US
Johns Dental Laboratory
Terre Haute, IN, US
Airway Management Inc.
Farmers Branch, TX, US
Slow Wave, Inc.
Lakeway, TX, US
The Snore Reliever Company
Largo, FL, US
Shun Hsiang Plastic Co.,ltd.
Taoyuan, TW
Apex Dental Sleep Lab
La Mesa, CA, US
New Image Dental Laboratory, Inc.
Morrow, GA, US
Five Star Orthodontic Laboratory & Supply, Inc.
Denton, TX, US
510(k) clearances
214 clearances for this product code
- DnB Innovations, LLCJul 31, 2026
K261912 · SnØreNegatØr
- Somnomed, Inc.Jun 12, 2026
K261366 · Virtus
- Endeavor Commerce, LLCJun 11, 2026
K261251 · Snorbliss® Anti-Snoring Device
- Koncept Innovators, Inc.May 14, 2026
K261134 · Dormiva Anti-Snoring Mouth Guard
- Shaeferh, LLCApr 10, 2026
K252942 · ShaeferH
- Ram.Shaw Pte. , Ltd.Mar 3, 2026
K253845 · Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB)
- Myofunctional Research Co.Mar 2, 2026
K252531 · Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2)
- Park Dental Research Corp.Dec 18, 2025
K252976 · Park Dental Nylon MAD