FDA Browser
by
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
K
93
1615
NITE-GUIDE
1
Cleared 510(K)
K
94
2667
DENT-O-CRYL ORTHODONTIC ACRYLIC
1
Cleared 510(K)
K
92
4351
GLENROE ELASTIBITE STIMULATOR
1
Cleared 510(K)
K
92
5064
RELAX-O-GUARD
1
Cleared 510(K)
K
92
4975
THE ORTHOTRAINER
1
Cleared 510(K)
K
92
4974
THE TMJ APPLIANCE
1
Cleared 510(K)
K
90
4128
PERFORMED TEMPLATE W/FRAGRANCE FOR TOOTH POSTIONER
1
Cleared 510(K)
K
89
1328
PREFORMED TEMPLATE FOR TOOTH POSITIONER
1
Cleared 510(K)
K
83
3455
REMOLDABLE CRANIOMANDIBULAR APPLIANCE
1
Cleared 510(K)
K
83
1793
AQUALIZER MOUTHPIECE
1
Cleared 510(K)
Show All 12 Submissions
LQZ
Device, Jaw Repositioning
2
Product Code
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
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 16 August 2024 at 11:05 pm
DE
/
subpart-f—therapeutic-devices
/
KMY
/
K931615
View Source
NITE-GUIDE
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K931615
510(k) Type
Traditional
Applicant
ORTHO-TAIN, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/14/1995
Days to Decision
743 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
K
93
1615
NITE-GUIDE
K
94
2667
DENT-O-CRYL ORTHODONTIC ACRYLIC
K
92
4351
GLENROE ELASTIBITE STIMULATOR
K
92
5064
RELAX-O-GUARD
K
92
4975
THE ORTHOTRAINER
K
92
4974
THE TMJ APPLIANCE
K
90
4128
PERFORMED TEMPLATE W/FRAGRANCE FOR TOOTH POSTIONER
K
89
1328
PREFORMED TEMPLATE FOR TOOTH POSITIONER
K
83
3455
REMOLDABLE CRANIOMANDIBULAR APPLIANCE
K
83
1793
AQUALIZER MOUTHPIECE
Show All 12 Submissions
LQZ
Device, Jaw Repositioning
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
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
/
KMY
/
K931615
View Source
NITE-GUIDE
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K931615
510(k) Type
Traditional
Applicant
ORTHO-TAIN, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/14/1995
Days to Decision
743 days
Submission Type
Summary