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Review Panel
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Review Panel
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Review Panel
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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
K
23
3754
AIO Breathe
2
Cleared 510(K)
K
23
0532
RADx Intraoral Appliance for Snoring and Sleep Apnea
2
Cleared 510(K)
K
20
3712
The Slide
2
Cleared 510(K)
K
19
1320
Slow Wave DS8
2
Cleared 510(K)
K
19
2581
The NightBlocks Appliance
2
Cleared 510(K)
K
16
2816
SML-OSA2 Appliances
2
Cleared 510(K)
K
13
0130
ATG/SM-OSA APPLIANCES
2
Cleared 510(K)
K
11
2627
MILLENIUM ANTI-SNORING DEVICE
2
Cleared 510(K)
K
11
2766
SNORKEL
2
Cleared 510(K)
K
11
3201
NARVAL CC
2
Cleared 510(K)
K
09
0911
IST SNORING APPLIANCE
2
Cleared 510(K)
K
09
1035
FULL BREATH SLEEP APPLIANCE LOWER (FBSL)
2
Cleared 510(K)
K
06
1228
FULL BREATH SLEEP APPLIANCE WITH POSTERIOR TONGUE DEPRESSOR
2
Cleared 510(K)
K
05
3065
FULL BREATH SLEEP APPLIANCE - PB (POSTERIOR BITE AND PBB (POSTERIOR BITE WITH BUMPS)
2
Cleared 510(K)
K
05
2862
FULL BREATH SLEEP APPLIANCE - AB (ANTERIOR BITE)
2
Cleared 510(K)
K
03
2410
SNORENTI
2
Cleared 510(K)
K
97
1818
SNOREX
2
Cleared 510(K)
K
96
0673
OSAP
2
Cleared 510(K)
K
95
5503
ADJUSTABLE PM POSITIONER
2
Cleared 510(K)
K
95
3293
PM POSITIONER
2
Cleared 510(K)
K
94
5820
DESRA
2
Cleared 510(K)
K
94
6112
ELASTOMERIC SLEEP APPLIANCE
2
Cleared 510(K)
K
93
2932
SNOREMASTER SNORE REMEDY
2
Cleared 510(K)
K
92
2818
SNORE-NO-MORE
2
Cleared 510(K)
K
90
2790
NAPA
2
Cleared 510(K)
K
88
0956
SNOAR(TM) OPEN AIRWAY APPLIANCE
2
Cleared 510(K)
K
87
0501
THE EQUALIZER AIRWAY DEVICE
2
Cleared 510(K)
LRK
Device, Anti-Snoring
2
Product Code
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
Review Panel
Gastroenterology and Urology
Review Panel
General Hospital
Review Panel
Hematology
Review Panel
Immunology
Review Panel
Microbiology
Review Panel
Neurology
Review Panel
Obstetrical and Gynecological
Review Panel
Ophthalmic
Review Panel
Orthopedic
Review Panel
Pathology
Review Panel
Physical Medicine
Review Panel
Radiology
Review Panel
General and Plastic Surgery
Review Panel
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 20 December 2024 at 11:05 pm
DE
/
subpart-f—therapeutic-devices
/
LQZ
/
K880956
View Source
SNOAR(TM) OPEN AIRWAY APPLIANCE
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K880956
510(k) Type
Traditional
Applicant
KENT J. TOONE, D.D.S.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/11/1988
Days to Decision
65 days
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
K
23
3754
AIO Breathe
K
23
0532
RADx Intraoral Appliance for Snoring and Sleep Apnea
K
20
3712
The Slide
K
19
1320
Slow Wave DS8
K
19
2581
The NightBlocks Appliance
K
16
2816
SML-OSA2 Appliances
K
13
0130
ATG/SM-OSA APPLIANCES
K
11
2627
MILLENIUM ANTI-SNORING DEVICE
K
11
2766
SNORKEL
K
11
3201
NARVAL CC
K
09
0911
IST SNORING APPLIANCE
K
09
1035
FULL BREATH SLEEP APPLIANCE LOWER (FBSL)
K
06
1228
FULL BREATH SLEEP APPLIANCE WITH POSTERIOR TONGUE DEPRESSOR
K
05
3065
FULL BREATH SLEEP APPLIANCE - PB (POSTERIOR BITE AND PBB (POSTERIOR BITE WITH BUMPS)
K
05
2862
FULL BREATH SLEEP APPLIANCE - AB (ANTERIOR BITE)
K
03
2410
SNORENTI
K
97
1818
SNOREX
K
96
0673
OSAP
K
95
5503
ADJUSTABLE PM POSITIONER
K
95
3293
PM POSITIONER
K
94
5820
DESRA
K
94
6112
ELASTOMERIC SLEEP APPLIANCE
K
93
2932
SNOREMASTER SNORE REMEDY
K
92
2818
SNORE-NO-MORE
K
90
2790
NAPA
K
88
0956
SNOAR(TM) OPEN AIRWAY APPLIANCE
K
87
0501
THE EQUALIZER AIRWAY DEVICE
LRK
Device, Anti-Snoring
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
/
LQZ
/
K880956
View Source
SNOAR(TM) OPEN AIRWAY APPLIANCE
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K880956
510(k) Type
Traditional
Applicant
KENT J. TOONE, D.D.S.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/11/1988
Days to Decision
65 days