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Innolitics
Anesthesiology
Review Panel
Cardiovascular
Review Panel
Chemistry
Review Panel
Dental
Review Panel
Miscellaneous
Miscellaneous
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart B—Physical Medicine Diagnostic Devices
CFR Sub-Part
Subpart D—Physical Medicine Prosthetic Devices
CFR Sub-Part
Subpart D—Prosthetic Devices
CFR Sub-Part
Subpart E—Surgical Devices
CFR Sub-Part
Subpart F—Physical Medicine Therapeutic Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
DYJ
Retainer, Screw Expansion, Orthodontic
1
Product Code
DYO
Band, Material, Orthodontic
1
Product Code
DYT
Maintainer, Space Preformed, Orthodontic
1
Product Code
DYW
Bracket, Plastic, Orthodontic
2
Product Code
DZB
Headgear, Extraoral, Orthodontic
2
Product Code
DZC
Wire, Orthodontic
1
Product Code
DZD
Tube, Orthodontic
1
Product Code
ECI
Band, Elastic, Orthodontic
1
Product Code
ECM
Band, Preformed, Orthodontic
1
Product Code
ECN
Clamp, Wire, Orthodontic
1
Product Code
ECO
Spring, Orthodontic
1
Product Code
EJF
Bracket, Metal, Orthodontic
1
Product Code
KKO
Ring, Teething, Fluid-Filled
2
Product Code
KMY
Positioner, Tooth, Preformed
1
Product Code
LQZ
Device, Jaw Repositioning
2
Product Code
LRK
Device, Anti-Snoring
2
Product Code
K
23
4089
DNA Appliance
2
Cleared 510(K)
K
23
2025
Hushd Pro Avera
2
Cleared 510(K)
K
23
2735
EMA 3D
2
Cleared 510(K)
K
23
3850
Difiney Anti Snoring Device
2
Cleared 510(K)
K
24
0427
airVata™
2
Cleared 510(K)
K
23
1138
Aniti-Snore Mouthguard+
2
Cleared 510(K)
K
23
0947
C.A.R.E. Appliance (DNA, mRNA, mmRNA)
2
Cleared 510(K)
K
23
3434
Silent Nite® Sleep Appliance with the Glidewell Hinge™ (SNGLHG)
2
Cleared 510(K)
K
23
1663
The AVEOtsd (Tongue Stabilizing Device) Mouthpiece
2
Cleared 510(K)
K
22
3901
ApneaRX Pro
2
Cleared 510(K)
K
22
3624
Emerald Herbst
2
Cleared 510(K)
K
22
2872
DNA Appliance
2
Cleared 510(K)
K
22
0688
SilentZPro 2.0
2
Cleared 510(K)
K
22
2475
SNOR LOCK
2
Cleared 510(K)
K
22
1322
CUSTMBITE Snoring System
2
Cleared 510(K)
K
22
2127
Soft Palate Elevator
2
Cleared 510(K)
K
22
1889
ProSomnus EVO [PH] Sleep and Snore Device, ProSomnus EVO [PH] Sleep and Snore Device with Patient Monitoring
2
Cleared 510(K)
K
22
0330
Soundly Anti Snoring Device
2
Cleared 510(K)
K
21
3088
ZQuiet Advance
2
Cleared 510(K)
K
21
4096
Respire Clear
2
Cleared 510(K)
K
21
0636
Morpheus
2
Cleared 510(K)
K
21
3475
Elevo Snoring Intervention Set
2
Cleared 510(K)
K
21
1069
EndSnorZ Sleep Appliance
2
Cleared 510(K)
K
20
0657
SmartGuard Anti-Snoring Device
2
Cleared 510(K)
K
21
0203
mmRNA appliance
2
Cleared 510(K)
K
21
0910
Snore Bandit
2
Cleared 510(K)
K
21
0694
Silent Nite Sleep Appliance with the Glidewell Hinge
2
Cleared 510(K)
K
20
3606
Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep Elastic Mandibular Advancement (EMA)
2
Cleared 510(K)
K
20
3477
Classic
2
Cleared 510(K)
K
20
3462
Advanced Dental Appliance
2
Cleared 510(K)
K
20
2651
NOA Sleep Apnea and Snoring Device
2
Cleared 510(K)
K
20
1719
Vital Sleep
2
Cleared 510(K)
K
20
1484
Somnos Anti-Snoring Mouth Guard
2
Cleared 510(K)
K
20
2529
ProSomnus EVO Sleep and Snore Device, ProSomnus EVO Sleep and Snore Device with Patient Monitoring
2
Cleared 510(K)
K
20
2499
Diamond Digital Sleep Orthotic (DDSO)
2
Cleared 510(K)
K
19
2127
Respire Pink AT (Hard, Hard/Soft, EF)
2
Cleared 510(K)
K
19
3239
MPowRx Snoring Solution (also known as Good Morning Snore Solution)
2
Cleared 510(K)
K
19
1618
SleepTight Mouthpiece STZ
2
Cleared 510(K)
K
18
1416
Sapphire Dorsal Comfort Fit
2
Cleared 510(K)
K
19
0236
O2Vent Optima
2
Cleared 510(K)
K
18
3270
Silent Nite sl
2
Cleared 510(K)
K
19
0687
Twilite Appliance
2
Cleared 510(K)
K
19
0051
TD Clip
2
Cleared 510(K)
K
18
3443
SomnoDent Avant
2
Cleared 510(K)
K
19
0058
PureSleep (OTC use)
2
Cleared 510(K)
K
17
3064
ZAPnea Oral Appliance
2
Cleared 510(K)
K
18
2661
Kava and Kava with Herbst
2
Cleared 510(K)
K
18
0691
TrueDorsal Devices
2
Cleared 510(K)
K
18
2312
Zyppah Anti-Snoring Device
2
Cleared 510(K)
K
18
2202
SLEEPAPP
2
Cleared 510(K)
K
18
1107
Elevo® Kit Snoring Intervention Device
2
Cleared 510(K)
K
18
1123
ApnoDent Appliance
2
Cleared 510(K)
K
18
1396
Oral Device OA, Oral Device S
2
Cleared 510(K)
K
18
1482
myTAP2
2
Cleared 510(K)
K
17
2991
Advanced Dental Applicance
2
Cleared 510(K)
K
17
3856
Express 4 Sleep appliance/CPAP Sidekick appliance
2
Cleared 510(K)
K
18
0124
ZQuiet
2
Cleared 510(K)
K
17
2760
REST EAZY Appliance
2
Cleared 510(K)
K
17
1576
The Panthera Anti-Snoring X3 Device
2
Cleared 510(K)
K
17
1529
Snorer's Friend
2
Cleared 510(K)
K
17
0053
Meridian PM
2
Cleared 510(K)
K
17
0578
True Function Adjustable Herbst Appliances
2
Cleared 510(K)
K
17
0825
SnoreRx
2
Cleared 510(K)
K
17
1316
O2Vent W
2
Cleared 510(K)
K
16
3580
ASD Oral Appliances
2
Cleared 510(K)
K
17
0692
Respire Pink Series with DentiTrac
2
Cleared 510(K)
K
16
1980
Fuselier Intraoral Nighttime Device (FIND)
2
Cleared 510(K)
K
16
2192
BluePro
2
Cleared 510(K)
K
15
2660
HYPNOSPAD
2
Cleared 510(K)
K
16
1832
O2VENT T
2
Cleared 510(K)
K
16
2306
SomnoDent ALPHA
2
Cleared 510(K)
K
16
0531
Noiselezz
2
Cleared 510(K)
K
15
3200
SnoreRx
2
Cleared 510(K)
K
16
0123
Apinator
2
Cleared 510(K)
K
15
3291
SICAT OPTISLEEP
2
Cleared 510(K)
K
15
0566
Oniris
2
Cleared 510(K)
K
16
0234
OVENT
2
Cleared 510(K)
K
15
2292
Respire Blue Series-EF
2
Cleared 510(K)
K
15
2159
Oravan Herbst
2
Cleared 510(K)
K
15
0572
Respire Pink Series-Herbst-EF
2
Cleared 510(K)
K
14
2651
The Moses Express appliance
2
Cleared 510(K)
K
15
0941
Somnowell Mandibular Advancement Appliance (MAA)
2
Cleared 510(K)
K
14
3591
Dorsal Appliance
2
Cleared 510(K)
K
14
3244
The Panthera Anti-Snoring Device
2
Cleared 510(K)
K
14
0663
THERASNORE
2
Cleared 510(K)
K
13
3390
NDX DORSAL APPLIANCE
2
Cleared 510(K)
K
14
0429
CRANE ACRYLIC HERBST APPLIANCE
2
Cleared 510(K)
K
14
0777
ZQUIET-SA
2
Cleared 510(K)
K
13
3683
MICR02 OSA DEVICE
2
Cleared 510(K)
K
14
0435
MEDLEY GOLD
2
Cleared 510(K)
K
14
0278
SOMNODENT FUSION, CLASSIC; SOMNODENT FUSION, FLEX
2
Cleared 510(K)
K
13
2506
SLEEPTIGHT MOUTHPIECE, SLEEPPRO, QUIETNITE, ALTITUDE MOUTHPIECE, SLEEP EASY
2
Cleared 510(K)
K
13
0067
MRNA APPLIANCE
2
Cleared 510(K)
K
13
2933
THE MOSES ELITE APPLIANCE
2
Cleared 510(K)
K
13
0797
LUCO HYBRID OSA APPLIANCE
2
Cleared 510(K)
K
13
0504
ASA ORAL APPLIANCES
2
Cleared 510(K)
K
13
1138
RESPIRE PINK SERIES - HERBST
2
Cleared 510(K)
K
11
3126
ACRYLIC HERBST APPLIANCE
2
Cleared 510(K)
K
13
0558
SOMNODENT HERBST; CLASSIC, FLEX
2
Cleared 510(K)
K
12
3410
HEALTHY SLEEP APPLIANCE
2
Cleared 510(K)
K
12
1285
ORAVAN OSA
2
Cleared 510(K)
K
12
2391
MEDTRONIC XOMED, INC.
2
Cleared 510(K)
K
11
3516
THERASOM-CAST
2
Cleared 510(K)
K
12
2475
ZQUIET PRO-PLUS
2
Cleared 510(K)
K
12
1344
NU SLEEP
2
Cleared 510(K)
K
12
1761
SOMNOGUARD SP SOFT
2
Cleared 510(K)
K
12
0372
DR GREENBURGS HYBRID VACUUM
2
Cleared 510(K)
K
12
0371
DR GREENBURGS HYBRID ACRYLIC
2
Cleared 510(K)
K
11
3022
PURESLEEP
2
Cleared 510(K)
K
12
1340
SOMNODENT G2
2
Cleared 510(K)
K
10
3704
REMOTELY CONTROLLED MANDIBULAR POSITIONER, RCMP
2
Cleared 510(K)
K
11
3569
APNEARX
2
Cleared 510(K)
K
11
0623
PILLAR PALATAL IMPLANT SYSTEM
2
Cleared 510(K)
K
11
1680
DR. GREENSBURG'S HYBRID
2
Cleared 510(K)
K
11
2205
SNORERX 9.0
2
Cleared 510(K)
K
11
1207
RESPIRE BLUE SERIES
2
Cleared 510(K)
K
11
1110
APNEA GUARD
2
Cleared 510(K)
K
11
1009
ACRYLIC HERBST APPLIANCE
2
Cleared 510(K)
K
10
2463
GOOD NIGHT
2
Cleared 510(K)
K
10
1155
AURADORM (NEUROMUSCULAR SLEEP)
2
Cleared 510(K)
K
10
2521
PANTINO PRO POSITINER
2
Cleared 510(K)
K
10
3004
SNORE GUARD
2
Cleared 510(K)
K
10
3076
DYNAFLEX
2
Cleared 510(K)
K
10
0185
SLEEP APP
2
Cleared 510(K)
K
10
2118
SNORE GUARD ADVANCE
2
Cleared 510(K)
K
10
1709
LAMBERGSLEEPWELL- SMARTRUSION (LSW-S)
2
Cleared 510(K)
K
09
3407
ZQUIET MOUTHPIECE
2
Cleared 510(K)
K
09
3340
PASR/QUIETNITE
2
Cleared 510(K)
K
09
3710
THE MOSES APPLIANCE
2
Cleared 510(K)
K
09
0436
AIRWAYEASE MAS
2
Cleared 510(K)
K
09
2942
VITAL SLEEP
2
Cleared 510(K)
K
08
2849
SILENT SLEEP
2
Cleared 510(K)
K
09
0503
ZQUIET MOUTHPIECE
2
Cleared 510(K)
K
08
3209
ACRYLIC HERBST SPLINT APPLIANCE
2
Cleared 510(K)
K
08
1965
MPOWRX SNORING SOLUTION
2
Cleared 510(K)
K
07
2731
ENDSNOR
2
Cleared 510(K)
K
07
3004
SOMNOMED BFLEX
2
Cleared 510(K)
K
07
0327
REMOVABLE ARYLIC HERBST, ALLESEE SNORE APPLIANCE (ASA), AND ENOCH SNORINATOR
2
Cleared 510(K)
K
06
0795
SOMNOFIT
2
Cleared 510(K)
K
06
2333
LAIMAD
2
Cleared 510(K)
K
06
2951
TAP III ANTI-SNORING DEVICE
2
Cleared 510(K)
K
06
1688
ANTI-SNORING / SLEEP APNEA DEVICE
2
Cleared 510(K)
K
06
1732
TAP-T
2
Cleared 510(K)
K
06
0744
O'BRIEN MPA (MANDIBULAR POSITIONING APPLICANCE)
2
Cleared 510(K)
K
06
0122
SLEEP SPLINT
2
Cleared 510(K)
K
06
0388
TAP II ANTI-SNORING AND OBSTRUCTIVE SLEEP APNEA ORAL APPLIANCE WITH ATTACHMENT
2
Cleared 510(K)
K
05
1014
SILENT PARTNER SERIES OSA APPLIANCES
2
Cleared 510(K)
K
05
0592
SOMNOMED MAS RXA
2
Cleared 510(K)
K
04
1184
NTI TENSION SUPPRESSION SYSTEM, WITH A SNOREHOOK APPLICATION
2
Cleared 510(K)
K
04
2161
ANTI-SNORING/SLEEP APNEA DEVICE
2
Cleared 510(K)
K
04
0417
PILLAR PALATAL IMPLANT SYSTEM
2
Cleared 510(K)
K
02
1569
RESTFUL NIGHTS, IST-APPLIANCE
2
Cleared 510(K)
K
03
3822
RESPIRONICS CUSTOM I ORAL APPLIANCE
2
Cleared 510(K)
K
03
3823
RESPIRONICS CUSTOM II ORAL APPLIANCE
2
Cleared 510(K)
K
03
0440
OASYS-ORAL AIRWAY SYSTEM
2
Cleared 510(K)
K
02
3836
THE SUAD DEVICE
2
Cleared 510(K)
K
02
2891
THE BREATHE EZ ANTI-SNORING DEVICE
2
Cleared 510(K)
K
01
1723
ANTI-SNORING DEVICE OR ASD
2
Cleared 510(K)
K
02
2284
SNORE-AID MAX
2
Cleared 510(K)
K
02
0893
NORAD NOCTURNAL ORAL AIRWAY DILATOR APPLIANCE
2
Cleared 510(K)
K
01
3687
NOSE BREATHE MOUTHPIECE FOR HEAVY SNORER
2
Cleared 510(K)
K
01
3808
SLEEPBITE
2
Cleared 510(K)
K
01
3049
NORAD, NOCTURNAL ORAL AIRWAY DILATOR APPLIANCE
2
Cleared 510(K)
K
01
2142
THE QUIET SLEEPER
2
Cleared 510(K)
K
99
3381
TONGUE STABILIZER DEVICE
2
Cleared 510(K)
K
99
1209
ORAL SLEEP DISORDER AID
2
Cleared 510(K)
K
99
1948
DR. B'S MOUTHPIECE, MODEL 32129-10002
2
Cleared 510(K)
K
98
1677
REPOSE BONE SCREW SYSTEM
2
Cleared 510(K)
K
99
1449
SNORE-AID PLUS
2
Cleared 510(K)
K
98
1923
THE SNORE PEACE
2
Cleared 510(K)
K
98
0952
SNORE-CURE ANTI-SNORING APPLIANCE
2
Cleared 510(K)
K
97
4531
SNORE-EZZER
2
Cleared 510(K)
K
97
3884
ELASTIC MANDIBULAR ADVANCEMENT - TITRATION (EMA-T) APPILANCE
2
Cleared 510(K)
K
96
3591
SNORING CONTROL DEVICE
2
Cleared 510(K)
K
97
3038
ADJUSTABLE THERASNORE
2
Cleared 510(K)
K
97
1794
ELASTIC MANDIBULAR ADVANCEMENT (EMA) APPLIANCE
2
Cleared 510(K)
K
97
2424
SILENTNITE
2
Cleared 510(K)
K
97
2023
SLEEP-IN BONE SCREW SYSTEM
2
Cleared 510(K)
K
97
2061
TOA
2
Cleared 510(K)
K
96
3063
SNORE TEC
2
Cleared 510(K)
K
96
4516
TAP
2
Cleared 510(K)
K
96
2516
TAP ANTI-SNORING DEVICE
2
Cleared 510(K)
K
95
5822
REMOVABLE HERBST APPLIANCE
2
Cleared 510(K)
K
95
5336
SNOREFREE
2
Cleared 510(K)
K
95
4530
THE SILENCER
2
Cleared 510(K)
K
95
4324
SNOR-X MOUTH GUARD
2
Cleared 510(K)
K
95
4128
SNOREMASTER
2
Cleared 510(K)
K
95
0763
LOWE KLEARWAY
2
Cleared 510(K)
K
92
6382
THERASNORE
2
Cleared 510(K)
K
92
2984
ORTHODONTIC BITE
2
Cleared 510(K)
K
89
5189
ADJUSTABLE SOFT PALATE LIFTER
2
Cleared 510(K)
K
88
2303
H&M ANTI-SNORING DEVICE
2
Cleared 510(K)
K
87
4416
DENTAL ANTI-SNORING DEVICE
2
Cleared 510(K)
LTF
Stimulator, Salivary System
2
Product Code
MEF
Ring, Teething, Non-Fluid Filled
1
Product Code
NJM
Bracket, Ceramic, Orthodontic
2
Product Code
NLC
Bracket, Plastic, Orthodontic, Reprocessed
2
Product Code
NQS
Bracket, Metal, Orthodontic, Reprocessed
1
Product Code
NTO
Rinse, Oral, Antibacterial (By Physical Means)
2
Product Code
NXC
Aligner, Sequential
2
Product Code
PLC
Sleep Appliances With Patient Monitoring
2
Product Code
OHP
Expiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea
2
Product Code
ORY
Prelude Tongue Suspension System
2
Product Code
OYH
Orthodontic Vibratory Accessory
2
Product Code
PLH
Orthodontic Led Accessory
2
Product Code
PNN
Orthodontic Software
2
Product Code
QCJ
Closed Loop Auto Titration Device For Oral Appliances
2
Product Code
QJJ
Indirect Bonding Tray
1
Product Code
QNO
Neuromuscular Tongue Muscle Stimulator For The Reduction Of Snoring And Obstructive Sleep Apnea
2
Product Code
QTT
Over The Counter Electrical Salivary Stimulatory System
2
Product Code
Subpart G—General Hospital and Personal Use Miscellaneous Devices
CFR Sub-Part
Subpart G—Miscellaneous Devices
CFR Sub-Part
Ear, Nose, Throat
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Gastroenterology and Urology
Review Panel
General Hospital
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Review Panel
Microbiology
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Review Panel
Obstetrical and Gynecological
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Ophthalmic
Review Panel
Orthopedic
Review Panel
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Review Panel
Physical Medicine
Review Panel
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Review Panel
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Review Panel
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Review Panel
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Review Panel
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Review Panel
Last synced on 30 November 2024 at 11:09 am
DE
/
subpart-f—therapeutic-devices
/
LRK
/
K150566
View Source
Oniris
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K150566
510(k) Type
Traditional
Applicant
SAS Oniris
Country
France
FDA Decision
Substantially Equivalent
Decision Date
3/21/2016
Days to Decision
381 days
Submission Type
Summary
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Miscellaneous
Subpart B—Diagnostic Devices
Subpart B—Physical Medicine Diagnostic Devices
Subpart D—Physical Medicine Prosthetic Devices
Subpart D—Prosthetic Devices
Subpart E—Surgical Devices
Subpart F—Physical Medicine Therapeutic Devices
Subpart F—Therapeutic Devices
DYJ
Retainer, Screw Expansion, Orthodontic
DYO
Band, Material, Orthodontic
DYT
Maintainer, Space Preformed, Orthodontic
DYW
Bracket, Plastic, Orthodontic
DZB
Headgear, Extraoral, Orthodontic
DZC
Wire, Orthodontic
DZD
Tube, Orthodontic
ECI
Band, Elastic, Orthodontic
ECM
Band, Preformed, Orthodontic
ECN
Clamp, Wire, Orthodontic
ECO
Spring, Orthodontic
EJF
Bracket, Metal, Orthodontic
KKO
Ring, Teething, Fluid-Filled
KMY
Positioner, Tooth, Preformed
LQZ
Device, Jaw Repositioning
LRK
Device, Anti-Snoring
K
23
4089
DNA Appliance
K
23
2025
Hushd Pro Avera
K
23
2735
EMA 3D
K
23
3850
Difiney Anti Snoring Device
K
24
0427
airVata™
K
23
1138
Aniti-Snore Mouthguard+
K
23
0947
C.A.R.E. Appliance (DNA, mRNA, mmRNA)
K
23
3434
Silent Nite® Sleep Appliance with the Glidewell Hinge™ (SNGLHG)
K
23
1663
The AVEOtsd (Tongue Stabilizing Device) Mouthpiece
K
22
3901
ApneaRX Pro
K
22
3624
Emerald Herbst
K
22
2872
DNA Appliance
K
22
0688
SilentZPro 2.0
K
22
2475
SNOR LOCK
K
22
1322
CUSTMBITE Snoring System
K
22
2127
Soft Palate Elevator
K
22
1889
ProSomnus EVO [PH] Sleep and Snore Device, ProSomnus EVO [PH] Sleep and Snore Device with Patient Monitoring
K
22
0330
Soundly Anti Snoring Device
K
21
3088
ZQuiet Advance
K
21
4096
Respire Clear
K
21
0636
Morpheus
K
21
3475
Elevo Snoring Intervention Set
K
21
1069
EndSnorZ Sleep Appliance
K
20
0657
SmartGuard Anti-Snoring Device
K
21
0203
mmRNA appliance
K
21
0910
Snore Bandit
K
21
0694
Silent Nite Sleep Appliance with the Glidewell Hinge
K
20
3606
Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep Elastic Mandibular Advancement (EMA)
K
20
3477
Classic
K
20
3462
Advanced Dental Appliance
K
20
2651
NOA Sleep Apnea and Snoring Device
K
20
1719
Vital Sleep
K
20
1484
Somnos Anti-Snoring Mouth Guard
K
20
2529
ProSomnus EVO Sleep and Snore Device, ProSomnus EVO Sleep and Snore Device with Patient Monitoring
K
20
2499
Diamond Digital Sleep Orthotic (DDSO)
K
19
2127
Respire Pink AT (Hard, Hard/Soft, EF)
K
19
3239
MPowRx Snoring Solution (also known as Good Morning Snore Solution)
K
19
1618
SleepTight Mouthpiece STZ
K
18
1416
Sapphire Dorsal Comfort Fit
K
19
0236
O2Vent Optima
K
18
3270
Silent Nite sl
K
19
0687
Twilite Appliance
K
19
0051
TD Clip
K
18
3443
SomnoDent Avant
K
19
0058
PureSleep (OTC use)
K
17
3064
ZAPnea Oral Appliance
K
18
2661
Kava and Kava with Herbst
K
18
0691
TrueDorsal Devices
K
18
2312
Zyppah Anti-Snoring Device
K
18
2202
SLEEPAPP
K
18
1107
Elevo® Kit Snoring Intervention Device
K
18
1123
ApnoDent Appliance
K
18
1396
Oral Device OA, Oral Device S
K
18
1482
myTAP2
K
17
2991
Advanced Dental Applicance
K
17
3856
Express 4 Sleep appliance/CPAP Sidekick appliance
K
18
0124
ZQuiet
K
17
2760
REST EAZY Appliance
K
17
1576
The Panthera Anti-Snoring X3 Device
K
17
1529
Snorer's Friend
K
17
0053
Meridian PM
K
17
0578
True Function Adjustable Herbst Appliances
K
17
0825
SnoreRx
K
17
1316
O2Vent W
K
16
3580
ASD Oral Appliances
K
17
0692
Respire Pink Series with DentiTrac
K
16
1980
Fuselier Intraoral Nighttime Device (FIND)
K
16
2192
BluePro
K
15
2660
HYPNOSPAD
K
16
1832
O2VENT T
K
16
2306
SomnoDent ALPHA
K
16
0531
Noiselezz
K
15
3200
SnoreRx
K
16
0123
Apinator
K
15
3291
SICAT OPTISLEEP
K
15
0566
Oniris
K
16
0234
OVENT
K
15
2292
Respire Blue Series-EF
K
15
2159
Oravan Herbst
K
15
0572
Respire Pink Series-Herbst-EF
K
14
2651
The Moses Express appliance
K
15
0941
Somnowell Mandibular Advancement Appliance (MAA)
K
14
3591
Dorsal Appliance
K
14
3244
The Panthera Anti-Snoring Device
K
14
0663
THERASNORE
K
13
3390
NDX DORSAL APPLIANCE
K
14
0429
CRANE ACRYLIC HERBST APPLIANCE
K
14
0777
ZQUIET-SA
K
13
3683
MICR02 OSA DEVICE
K
14
0435
MEDLEY GOLD
K
14
0278
SOMNODENT FUSION, CLASSIC; SOMNODENT FUSION, FLEX
K
13
2506
SLEEPTIGHT MOUTHPIECE, SLEEPPRO, QUIETNITE, ALTITUDE MOUTHPIECE, SLEEP EASY
K
13
0067
MRNA APPLIANCE
K
13
2933
THE MOSES ELITE APPLIANCE
K
13
0797
LUCO HYBRID OSA APPLIANCE
K
13
0504
ASA ORAL APPLIANCES
K
13
1138
RESPIRE PINK SERIES - HERBST
K
11
3126
ACRYLIC HERBST APPLIANCE
K
13
0558
SOMNODENT HERBST; CLASSIC, FLEX
K
12
3410
HEALTHY SLEEP APPLIANCE
K
12
1285
ORAVAN OSA
K
12
2391
MEDTRONIC XOMED, INC.
K
11
3516
THERASOM-CAST
K
12
2475
ZQUIET PRO-PLUS
K
12
1344
NU SLEEP
K
12
1761
SOMNOGUARD SP SOFT
K
12
0372
DR GREENBURGS HYBRID VACUUM
K
12
0371
DR GREENBURGS HYBRID ACRYLIC
K
11
3022
PURESLEEP
K
12
1340
SOMNODENT G2
K
10
3704
REMOTELY CONTROLLED MANDIBULAR POSITIONER, RCMP
K
11
3569
APNEARX
K
11
0623
PILLAR PALATAL IMPLANT SYSTEM
K
11
1680
DR. GREENSBURG'S HYBRID
K
11
2205
SNORERX 9.0
K
11
1207
RESPIRE BLUE SERIES
K
11
1110
APNEA GUARD
K
11
1009
ACRYLIC HERBST APPLIANCE
K
10
2463
GOOD NIGHT
K
10
1155
AURADORM (NEUROMUSCULAR SLEEP)
K
10
2521
PANTINO PRO POSITINER
K
10
3004
SNORE GUARD
K
10
3076
DYNAFLEX
K
10
0185
SLEEP APP
K
10
2118
SNORE GUARD ADVANCE
K
10
1709
LAMBERGSLEEPWELL- SMARTRUSION (LSW-S)
K
09
3407
ZQUIET MOUTHPIECE
K
09
3340
PASR/QUIETNITE
K
09
3710
THE MOSES APPLIANCE
K
09
0436
AIRWAYEASE MAS
K
09
2942
VITAL SLEEP
K
08
2849
SILENT SLEEP
K
09
0503
ZQUIET MOUTHPIECE
K
08
3209
ACRYLIC HERBST SPLINT APPLIANCE
K
08
1965
MPOWRX SNORING SOLUTION
K
07
2731
ENDSNOR
K
07
3004
SOMNOMED BFLEX
K
07
0327
REMOVABLE ARYLIC HERBST, ALLESEE SNORE APPLIANCE (ASA), AND ENOCH SNORINATOR
K
06
0795
SOMNOFIT
K
06
2333
LAIMAD
K
06
2951
TAP III ANTI-SNORING DEVICE
K
06
1688
ANTI-SNORING / SLEEP APNEA DEVICE
K
06
1732
TAP-T
K
06
0744
O'BRIEN MPA (MANDIBULAR POSITIONING APPLICANCE)
K
06
0122
SLEEP SPLINT
K
06
0388
TAP II ANTI-SNORING AND OBSTRUCTIVE SLEEP APNEA ORAL APPLIANCE WITH ATTACHMENT
K
05
1014
SILENT PARTNER SERIES OSA APPLIANCES
K
05
0592
SOMNOMED MAS RXA
K
04
1184
NTI TENSION SUPPRESSION SYSTEM, WITH A SNOREHOOK APPLICATION
K
04
2161
ANTI-SNORING/SLEEP APNEA DEVICE
K
04
0417
PILLAR PALATAL IMPLANT SYSTEM
K
02
1569
RESTFUL NIGHTS, IST-APPLIANCE
K
03
3822
RESPIRONICS CUSTOM I ORAL APPLIANCE
K
03
3823
RESPIRONICS CUSTOM II ORAL APPLIANCE
K
03
0440
OASYS-ORAL AIRWAY SYSTEM
K
02
3836
THE SUAD DEVICE
K
02
2891
THE BREATHE EZ ANTI-SNORING DEVICE
K
01
1723
ANTI-SNORING DEVICE OR ASD
K
02
2284
SNORE-AID MAX
K
02
0893
NORAD NOCTURNAL ORAL AIRWAY DILATOR APPLIANCE
K
01
3687
NOSE BREATHE MOUTHPIECE FOR HEAVY SNORER
K
01
3808
SLEEPBITE
K
01
3049
NORAD, NOCTURNAL ORAL AIRWAY DILATOR APPLIANCE
K
01
2142
THE QUIET SLEEPER
K
99
3381
TONGUE STABILIZER DEVICE
K
99
1209
ORAL SLEEP DISORDER AID
K
99
1948
DR. B'S MOUTHPIECE, MODEL 32129-10002
K
98
1677
REPOSE BONE SCREW SYSTEM
K
99
1449
SNORE-AID PLUS
K
98
1923
THE SNORE PEACE
K
98
0952
SNORE-CURE ANTI-SNORING APPLIANCE
K
97
4531
SNORE-EZZER
K
97
3884
ELASTIC MANDIBULAR ADVANCEMENT - TITRATION (EMA-T) APPILANCE
K
96
3591
SNORING CONTROL DEVICE
K
97
3038
ADJUSTABLE THERASNORE
K
97
1794
ELASTIC MANDIBULAR ADVANCEMENT (EMA) APPLIANCE
K
97
2424
SILENTNITE
K
97
2023
SLEEP-IN BONE SCREW SYSTEM
K
97
2061
TOA
K
96
3063
SNORE TEC
K
96
4516
TAP
K
96
2516
TAP ANTI-SNORING DEVICE
K
95
5822
REMOVABLE HERBST APPLIANCE
K
95
5336
SNOREFREE
K
95
4530
THE SILENCER
K
95
4324
SNOR-X MOUTH GUARD
K
95
4128
SNOREMASTER
K
95
0763
LOWE KLEARWAY
K
92
6382
THERASNORE
K
92
2984
ORTHODONTIC BITE
K
89
5189
ADJUSTABLE SOFT PALATE LIFTER
K
88
2303
H&M ANTI-SNORING DEVICE
K
87
4416
DENTAL ANTI-SNORING DEVICE
LTF
Stimulator, Salivary System
MEF
Ring, Teething, Non-Fluid Filled
NJM
Bracket, Ceramic, Orthodontic
NLC
Bracket, Plastic, Orthodontic, Reprocessed
NQS
Bracket, Metal, Orthodontic, Reprocessed
NTO
Rinse, Oral, Antibacterial (By Physical Means)
NXC
Aligner, Sequential
PLC
Sleep Appliances With Patient Monitoring
OHP
Expiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea
ORY
Prelude Tongue Suspension System
OYH
Orthodontic Vibratory Accessory
PLH
Orthodontic Led Accessory
PNN
Orthodontic Software
QCJ
Closed Loop Auto Titration Device For Oral Appliances
QJJ
Indirect Bonding Tray
QNO
Neuromuscular Tongue Muscle Stimulator For The Reduction Of Snoring And Obstructive Sleep Apnea
QTT
Over The Counter Electrical Salivary Stimulatory System
Subpart G—General Hospital and Personal Use Miscellaneous Devices
Subpart G—Miscellaneous Devices
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
DE
/
subpart-f—therapeutic-devices
/
LRK
/
K150566
View Source
Oniris
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K150566
510(k) Type
Traditional
Applicant
SAS Oniris
Country
France
FDA Decision
Substantially Equivalent
Decision Date
3/21/2016
Days to Decision
381 days
Submission Type
Summary