Product Code: LRK


Products Classified as LRK

1312Device, Anti-snoringIntraoral Devices For Snoring And Intraoral Devices For Snoring And Obstructive Sleep Apnea.

Total Product Life Cycle (TPLC) Devices

1312Device, Anti-snoringIntraoral Devices For Snoring And Intraoral Devices For Snoring And Obstructive Sleep Apnea.

FDA Consensus Standards

Device, Anti-Snoring [32309]21 CFR §872.5570 🔎
Device, Anti-Snoring [35851]21 CFR §872.5570 🔎
Device, Anti-Snoring [35869]21 CFR §872.5570 🔎

Pre-market Notifications for LRK

K222475SNOR LOCKSolbaro Co., Ltd
K221889ProSomnus EVO [PH] Sleep And Snore Device, ProSomnus EVO [PH] Sleep And Snore Device With Patient MonitoringProSomnus Sleep Technologies
K221322CUSTMBITE Snoring SystemDental Choice Holdings LLC
K220688SilentZPro 2.0Shinrin-Yoku Traders LLC
K220330Soundly Anti Snoring DeviceGreystone IP Ltd
K213475Elevo Snoring Intervention SetZelegent, Inc.
K213088ZQuiet AdvanceSleeping Well, LLC
K210910Snore BanditSnoreBandit LLC
K210694Silent Nite Sleep Appliance With The Glidewell HingePrismatik Dentalcraft, Inc.
K210203MmRNA ApplianceVivos Therapeutics, Inc. (formerly Vivos Biotechnologies, I)
K203606Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep Elastic Mandibular Advancement (EMA)Meris Investment Group
K203477ClassicOrthoapnea S.L.
K203462Advanced Dental ApplianceDaSoft Partners
K202651NOA Sleep Apnea And Snoring DeviceOrthoapnea S.L.
K202499Diamond Digital Sleep Orthotic (DDSO)Diamond Orthotic Laboratory

Global Unique Device Identification Database

00643169107779Device, anti-snoring
00643169062979Device, anti-snoring
00643169523272Device, anti-snoring
00643169523265Device, anti-snoring
00792293062000Device, Anti-Snoring
00763000089757Device, anti-snoring
00866868000381Device, Anti-Snoring
00866868000343Device, Anti-Snoring
00866868000336Device, Anti-Snoring
00866868000329Device, Anti-Snoring
00866868000312Device, Anti-Snoring
00866868000305Device, Anti-Snoring
00863039000423Device, Anti-Snoring
00863039000416Device, Anti-Snoring
00863039000409Device, Anti-Snoring

Maude Adverse Events

XTRA SILENT NITEPRISMATIK DENTALCRAFT, INC.2020-03-27
DREAM TAPPRISMATIK DENTALCRAFT, INC.2020-02-20
TAP IIIPRISMATIK DENTALCRAFT, INC.2020-02-19
TAP IIIPRISMATIK DENTALCRAFT, INC.2020-02-19
ZYPPAH SNORING APPLIANCEZYPPAH, INC.2020-02-07
XTRA SILENT NITEPRISMATIK DENTALCRAFT, INC.2020-01-10
DREAM TAPPRISMATIK DENTALCRAFT, INC.2020-01-06
XTRA SILENT NITEPRISMATIK DENTALCRAFT INC.2019-12-10
DREAM TAPPRISMATIK DENTALCRAFT INC.2019-12-10
DREAM TAPPRISMATIK DENTALCRAFT INC.2019-12-10
XTRA SILENT NITEPRISMATIK DENTALCRAFT INC.2019-11-25
DREAM TAPPRISMATIK DENTALCRAFT INC.2019-11-08
EMAELASTIC MANDIBULAR ADVANCEMENT APPLIANCEMYERSON COMPANY LIMITED2019-10-31
ADJUSTABLE HERBST SLEEP APPLIANCEDYNAFLEX2019-10-24
ADJUSTABLE HERBST APPLIANCEDYNAFLEX2019-10-24
TAP IIIPRISMATIK DENTALCRAFT INC.2019-10-15
SNORE GUARDRANIR LLC2019-10-15
DREAM TAPPRISMATIK DENTALCRAFT INC.2019-10-15
SNOREGUARDRANIR2019-09-26
XTRA SILENT NITEPRISMATIK DENTALCRAFT INC.2019-09-17
TAP IIIPRISMATIK DENTALCRAFT INC.2019-09-16
XTRA SILENT NITEPRISMATIK DENTALCRAFT INC.2019-09-16
XTRA SILENT NITEPRISMATIK DENTALCRAFT INC.2019-08-16
XTRA SILENT NITEPRISMATIK DENTALCRAFT INC.2019-08-16
XTRA SILENT NITEPRISMATIK DENTALCRAFT INC.2019-08-06
DREAMTAPPRISMATIK DENTALCRAFT, INC.2019-07-31
SNORE GUARDRANIR LLC2019-07-26
TAP IIIPRISMATIK DENTALCRAFT, INC.2019-07-16
EMAANTI-SNORING MOUTHGUARDPRISMATIK DENTALCRAFT, INC.2019-06-27
XTRA SILENT NITEPRISMATIK DENTALCRAFT, INC.2019-06-21
XTRA SILENT NITEPRISMATIK DENTALCRAFT, INC.2019-06-12
PROSOMNUS [IA] DEVICEPROSOMNUS SLEEP TECHNOLOGIES2019-06-06
XTRA SILENT NITEPRISMATIK DENTALCRAFT, INC.2019-05-22
XTRA SILENT NITEPRISMATIK DENTALCRAFT, INC.2019-05-22
XTRA SILENT NITEPRISMATIK DENTALCRAFT, INC.2019-05-22
RESPIRE PINK SERIES WITH DENTITRACRESPIRE MEDICAL HOLDING2019-05-01
EMAANTI-SNORING DEVICE, EMAPRISMATIK DENTALCRAFT, INC.2019-04-25
EMAANTI-SNORING DEVICE, EMAPRISMATIK DENTALCRAFT, INC.2019-04-25
SNORE GUARDRANIR LLC2019-04-23
SNORE GUARDRANIR LLC2019-04-09
DENTAL ORAL APPLIANCE FOR SLEEP APNEAUNKNOWN2019-04-08
XTRA SILENT NITEPRISMATIK DENTALCRAFT, INC.2019-03-19
SNORE GUARDRANIR LLC2019-03-04
SNORE GUARDRANIR LLC2019-03-01
SNORE GUARDRANIR LLC2019-02-28
DREAMTAPPRISMATIK DENTALCRAFT, INC.2019-02-25
XTRA SILENT NITEPRISMATIK DENTALCRAFT, INC.2019-02-18
XTRA SILENT NITEPRISMATIK DENTALCRAFT, INC.2019-02-18
SNORE GUARDRANIR LLC2019-02-06
SNORE GUARDRANIR LLC2019-02-06
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