Product Code: LRK FDA class 2 21 CFR 872.5570

Device, Anti-Snoring

Dental

The Anti-Snoring Device is a dental appliance designed to reposition the mandible or maintain airway patency during sleep to reduce or eliminate snoring, typically through oral repositioning mechanisms. It is classified as a Class 2 (moderate risk) device, subject to general and special controls, and requires 510(k) premarket notification. The product code is LRK, regulated under 21 CFR 872.5570, within the Dental medical specialty. This device is eligible for third-party review under the FDA's accredited persons program.

510(k)s
213
FEI Numbers
105
Registration Numbers
105
Unique Applicants
154
Years Active
38

Basic Information

Product Code
LRK
Device Class
FDA class 2
Regulation Number
872.5570
Medical Specialty
Dental
Review Panel
DE
Submission Type
1

Device Characteristics

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting

510(k) Clearance History

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Related 510(k) Clearances

This FDA classification is associated with 213 510(k) clearances via K numbers.

K Number Device Name
K261366 Virtus
K261251 Snorbliss® Anti-Snoring Device
K261134 Dormiva Anti-Snoring Mouth Guard
K252942 ShaeferH
K253845 Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB)
K252531 Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2)
K252976 Park Dental Nylon MAD
K253868 QuietLab Pro
K252161 Hushd Avera
K252525 AIO Breathe
K252698 NightGuard Aire Max
K253355 Difiney Advanced Anti Snoring Device 4.0
K251784 Hushd Pro Z-Link
K251628 Mandibular Advancement Device L07
K250028 Anti Snore Mouthpiece
K243752 Double Tube Herbst Appliance
K252374 Nylon flexTAP(R)
K250353 Oniris; Oniris Plus
K250122 SleepRight Snore Aid
K250482 Advanced Anti Snoring Device 4.0 Clear/ Advanced Anti Snoring Device 4.0 Blue
K234089 DNA Appliance
K232025 Hushd Pro Avera
K232735 EMA 3D
K233850 Difiney Anti Snoring Device
K240427 airVata™
K231138 Aniti-Snore Mouthguard+
K230947 C.A.R.E. Appliance (DNA, mRNA, mmRNA)
K233434 Silent Nite® Sleep Appliance with the Glidewell Hinge™ (SNGLHG)
K231663 The AVEOtsd (Tongue Stabilizing Device) Mouthpiece
K223901 ApneaRX Pro
K223624 Emerald Herbst
K222872 DNA Appliance
K220688 SilentZPro 2.0
K222475 SNOR LOCK
K221322 CUSTMBITE Snoring System
K222127 Soft Palate Elevator
K221889 ProSomnus EVO [PH] Sleep and Snore Device, ProSomnus EVO [PH] Sleep and Snore Device with Patient Monitoring
K220330 Soundly Anti Snoring Device
K213088 ZQuiet Advance
K214096 Respire Clear
K210636 Morpheus
K213475 Elevo Snoring Intervention Set
K211069 EndSnorZ Sleep Appliance
K200657 SmartGuard Anti-Snoring Device
K210203 mmRNA appliance
K210910 Snore Bandit
K210694 Silent Nite Sleep Appliance with the Glidewell Hinge
K203606 Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep Elastic Mandibular Advancement (EMA)
K203477 Classic
K203462 Advanced Dental Appliance
K202651 NOA Sleep Apnea and Snoring Device
K201719 Vital Sleep
K201484 Somnos Anti-Snoring Mouth Guard
K202529 ProSomnus EVO Sleep and Snore Device, ProSomnus EVO Sleep and Snore Device with Patient Monitoring
K202499 Diamond Digital Sleep Orthotic (DDSO)
K192127 Respire Pink AT (Hard, Hard/Soft, EF)
K193239 MPowRx Snoring Solution (also known as Good Morning Snore Solution)
K191618 SleepTight Mouthpiece STZ
K181416 Sapphire Dorsal Comfort Fit
K190236 O2Vent Optima
K183270 Silent Nite sl
K190687 Twilite Appliance
K190051 TD Clip
K183443 SomnoDent Avant
K190058 PureSleep (OTC use)
K173064 ZAPnea Oral Appliance
K182661 Kava and Kava with Herbst
K180691 TrueDorsal Devices
K182312 Zyppah Anti-Snoring Device
K182202 SLEEPAPP
K181107 Elevo® Kit Snoring Intervention Device
K181123 ApnoDent Appliance
K181396 Oral Device OA, Oral Device S
K181482 myTAP2
K172991 Advanced Dental Applicance
K173856 Express 4 Sleep appliance/CPAP Sidekick appliance
K180124 ZQuiet
K172760 REST EAZY Appliance
K171576 The Panthera Anti-Snoring X3 Device
K171529 Snorer's Friend
K170053 Meridian PM
K170578 True Function Adjustable Herbst Appliances
K170825 SnoreRx
K171316 O2Vent W
K163580 ASD Oral Appliances
K170692 Respire Pink Series with DentiTrac
K161980 Fuselier Intraoral Nighttime Device (FIND)
K162192 BluePro
K152660 HYPNOSPAD
K161832 O2VENT T
K162306 SomnoDent ALPHA
K160531 Noiselezz
K153200 SnoreRx
K160123 Apinator
K153291 SICAT OPTISLEEP
K150566 Oniris
K160234 OVENT
K152292 Respire Blue Series-EF
K152159 Oravan Herbst
K150572 Respire Pink Series-Herbst-EF
K142651 The Moses Express appliance
K150941 Somnowell Mandibular Advancement Appliance (MAA)
K143591 Dorsal Appliance
K143244 The Panthera Anti-Snoring Device
K140663 THERASNORE
K133390 NDX DORSAL APPLIANCE
K140429 CRANE ACRYLIC HERBST APPLIANCE
K140777 ZQUIET-SA
K133683 MICR02 OSA DEVICE
K140435 MEDLEY GOLD
K140278 SOMNODENT FUSION, CLASSIC; SOMNODENT FUSION, FLEX
K132506 SLEEPTIGHT MOUTHPIECE, SLEEPPRO, QUIETNITE, ALTITUDE MOUTHPIECE, SLEEP EASY
K130067 MRNA APPLIANCE
K132933 THE MOSES ELITE APPLIANCE
K130797 LUCO HYBRID OSA APPLIANCE
K130504 ASA ORAL APPLIANCES
K131138 RESPIRE PINK SERIES - HERBST
K113126 ACRYLIC HERBST APPLIANCE
K130558 SOMNODENT HERBST; CLASSIC, FLEX
K123410 HEALTHY SLEEP APPLIANCE
K121285 ORAVAN OSA
K122391 MEDTRONIC XOMED, INC.
K113516 THERASOM-CAST
K122475 ZQUIET PRO-PLUS
K121344 NU SLEEP
K121761 SOMNOGUARD SP SOFT
K120372 DR GREENBURGS HYBRID VACUUM
K120371 DR GREENBURGS HYBRID ACRYLIC
K113022 PURESLEEP
K121340 SOMNODENT G2
K103704 REMOTELY CONTROLLED MANDIBULAR POSITIONER, RCMP
K113569 APNEARX
K110623 PILLAR PALATAL IMPLANT SYSTEM
K111680 DR. GREENSBURG'S HYBRID
K112205 SNORERX 9.0
K111207 RESPIRE BLUE SERIES
K111110 APNEA GUARD
K111009 ACRYLIC HERBST APPLIANCE
K102463 GOOD NIGHT
K101155 AURADORM (NEUROMUSCULAR SLEEP)
K102521 PANTINO PRO POSITINER
K103004 SNORE GUARD
K103076 DYNAFLEX
K100185 SLEEP APP
K102118 SNORE GUARD ADVANCE
K101709 LAMBERGSLEEPWELL- SMARTRUSION (LSW-S)
K093407 ZQUIET MOUTHPIECE
K093340 PASR/QUIETNITE
K093710 THE MOSES APPLIANCE
K090436 AIRWAYEASE MAS
K092942 VITAL SLEEP
K082849 SILENT SLEEP
K090503 ZQUIET MOUTHPIECE
K083209 ACRYLIC HERBST SPLINT APPLIANCE
K081965 MPOWRX SNORING SOLUTION
K072731 ENDSNOR
K073004 SOMNOMED BFLEX
K070327 REMOVABLE ARYLIC HERBST, ALLESEE SNORE APPLIANCE (ASA), AND ENOCH SNORINATOR
K060795 SOMNOFIT
K062333 LAIMAD
K062951 TAP III ANTI-SNORING DEVICE
K061688 ANTI-SNORING / SLEEP APNEA DEVICE
K061732 TAP-T
K060744 O'BRIEN MPA (MANDIBULAR POSITIONING APPLICANCE)
K060122 SLEEP SPLINT
K060388 TAP II ANTI-SNORING AND OBSTRUCTIVE SLEEP APNEA ORAL APPLIANCE WITH ATTACHMENT
K051014 SILENT PARTNER SERIES OSA APPLIANCES
K050592 SOMNOMED MAS RXA
K041184 NTI TENSION SUPPRESSION SYSTEM, WITH A SNOREHOOK APPLICATION
K042161 ANTI-SNORING/SLEEP APNEA DEVICE
K040417 PILLAR PALATAL IMPLANT SYSTEM
K021569 RESTFUL NIGHTS, IST-APPLIANCE
K033823 RESPIRONICS CUSTOM II ORAL APPLIANCE
K033822 RESPIRONICS CUSTOM I ORAL APPLIANCE
K030440 OASYS-ORAL AIRWAY SYSTEM
K023836 THE SUAD DEVICE
K022891 THE BREATHE EZ ANTI-SNORING DEVICE
K011723 ANTI-SNORING DEVICE OR ASD
K022284 SNORE-AID MAX
K020893 NORAD NOCTURNAL ORAL AIRWAY DILATOR APPLIANCE
K013687 NOSE BREATHE MOUTHPIECE FOR HEAVY SNORER
K013808 SLEEPBITE
K013049 NORAD, NOCTURNAL ORAL AIRWAY DILATOR APPLIANCE
K012142 THE QUIET SLEEPER
K993381 TONGUE STABILIZER DEVICE
K991209 ORAL SLEEP DISORDER AID
K991948 DR. B'S MOUTHPIECE, MODEL 32129-10002
K981677 REPOSE BONE SCREW SYSTEM
K991449 SNORE-AID PLUS
K981923 THE SNORE PEACE
K980952 SNORE-CURE ANTI-SNORING APPLIANCE
K974531 SNORE-EZZER
K973884 ELASTIC MANDIBULAR ADVANCEMENT - TITRATION (EMA-T) APPILANCE
K963591 SNORING CONTROL DEVICE
K973038 ADJUSTABLE THERASNORE
K971794 ELASTIC MANDIBULAR ADVANCEMENT (EMA) APPLIANCE
K972424 SILENTNITE
K972023 SLEEP-IN BONE SCREW SYSTEM
K972061 TOA
K963063 SNORE TEC
K964516 TAP
K962516 TAP ANTI-SNORING DEVICE
K955822 REMOVABLE HERBST APPLIANCE
K955336 SNOREFREE
K954530 THE SILENCER
K954324 SNOR-X MOUTH GUARD
K954128 SNOREMASTER
K950763 LOWE KLEARWAY
K926382 THERASNORE
K922984 ORTHODONTIC BITE
K895189 ADJUSTABLE SOFT PALATE LIFTER
K882303 H&M ANTI-SNORING DEVICE
K874416 DENTAL ANTI-SNORING DEVICE

FEI Numbers

This FDA classification entry is associated with 105 FEI numbers. Click on an entry to view related FDA registrations.

Registration Numbers

This FDA classification entry is associated with 105 registration numbers. Click on an entry to view related FDA registrations.