LRK

Device, Anti-Snoring

产品代码
LRK
器械名称
Device, Anti-Snoring
管理类别
第 2 类(Class II)
21 CFR 条款
21 CFR 872.5570
FDA 专业组
Dental
上市路径
需提交 510(k) 上市前通告
标记
可走第三方审查
该代码近三年的 510(k)
31 件
其中 Summary 已存档
27 份,可直接下载
FDA 历史累计 510(k)
215 件(全部年份;本站只收录近三年的明细)

该代码近三年的 510(k)(31 件)

数据窗口为最近三年。最新一件:2026-08-27。

510(k) 号批准日期申请人器械名称摘要
K2621042026-08-27Ram.Shaw Pte., Ltd.Anti Snoring Mouthpiece (L09-BB, L09-PP, L09-TB, L09PDF
K2619122026-07-31DnB Innovations, LLCSnØreNegatØrPDF
K2613662026-06-12Somnomed, Inc.VirtusFDA
K2612512026-06-11Endeavor Commerce, LLCSnorbliss® Anti-Snoring DevicePDF
K2611342026-05-14Koncept Innovators, Inc.Dormiva Anti-Snoring Mouth GuardPDF
K2529422026-04-10Shaeferh, LLCShaeferHPDF
K2538452026-03-03Ram.Shaw Pte. , Ltd.Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08PDF
K2525312026-03-02Myofunctional Research Co.Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for SnorersPDF
K2529762025-12-18Park Dental Research Corp.Park Dental Nylon MADPDF
K2538682025-12-05QuietLab, LLCQuietLab ProPDF
K2521612025-11-25Good Sleep CO Pte , Ltd.Hushd AveraPDF
K2525252025-11-06Aiomega, LLCAIO BreatheFDA
K2526982025-11-03Nightguard Express, LLCNightGuard Aire MaxPDF
K2533552025-10-29Fissiontech, LLCDifiney Advanced Anti Snoring Device 4.0PDF
K2517842025-10-24Good Sleep CO Pte , Ltd.Hushd Pro Z-LinkPDF
K2516282025-10-22Dcstar, Inc.Mandibular Advancement Device L07PDF
K2500282025-10-03Dongguan Yiyao Science & Technology DeAnti Snore MouthpiecePDF
K2437522025-09-17The Tmj Clinic PCDouble Tube Herbst AppliancePDF
K2523742025-09-11Airway Technologies D/B/A Airway ManagNylon flexTAP(R)PDF
K2503532025-09-04OnirisOniris; Oniris PlusPDF
K2501222025-05-19Splintek, Inc.SleepRight Snore AidPDF
K2504822025-05-08Fissiontech, LLCAdvanced Anti Snoring Device 4.0 Clear/ Advanced AntPDF
K2340892024-09-16Vivos TherapeuticsDNA AppliancePDF
K2320252024-05-09Good Sleep CO Pte , Ltd.Hushd Pro AveraPDF
K2327352024-05-03Ema Sleep IncorporatedEMA 3DPDF
K2338502024-04-18Fissiontech, LLCDifiney Anti Snoring DevicePDF
K2404272024-02-14Gelb Practice Solutions, Inc.airVata™PDF
K2311382024-01-16Oscimed SAAniti-Snore Mouthguard+PDF
K2309472023-11-28Vivos Therapeutics, Inc.C.A.R.E. Appliance (DNA, mRNA, mmRNA)FDA
K2334342023-11-14Prismatik Dentalcraft, Inc.Silent Nite® Sleep Appliance with the Glidewell HingPDF
K2316632023-09-18Innovative Health Technologies (Nz), LThe AVEOtsd (Tongue Stabilizing Device) Mouthpiece

其中 27 件的 Summary 已存档在本站,点 PDF 直接下载;其余给 FDA 官方链接。

FDA 官方分类页: LRK
分类与上市路径以 FDA 现行公告为准。本页数据来自 openFDA(CC0 公有领域),不构成注册策略建议。