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
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
K
23
2827
LightForce Orthodontic System
2
Cleared 510(K)
K
23
2011
Cleo
2
Cleared 510(K)
K
23
1635
A-Line Advanced
2
Cleared 510(K)
K
23
0225
DynaFlex Clear Brackets & Buttons
2
Cleared 510(K)
K
22
2847
Ceramic Brackets Orthometric
2
Cleared 510(K)
K
22
2764
LightForce Orthodontic System
2
Cleared 510(K)
K
22
0689
Vatech Clismile
2
Cleared 510(K)
K
20
1410
VENUS Bracket, ROSE Bracket
2
Cleared 510(K)
K
20
1038
Luce Ceramic Bracket
2
Cleared 510(K)
K
20
0148
LightForce Orthodontic System (LFO System)
2
Cleared 510(K)
Show All 60 Submissions
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 13 December 2024 at 11:05 pm
DE
/
subpart-f—therapeutic-devices
/
NJM
/
K231635
View Source
A-Line Advanced
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K231635
510(k) Type
Traditional
Applicant
Biocetec Co., Ltd
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
6/6/2023
Days to Decision
1 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
LTF
Stimulator, Salivary System
MEF
Ring, Teething, Non-Fluid Filled
NJM
Bracket, Ceramic, Orthodontic
K
23
2827
LightForce Orthodontic System
K
23
2011
Cleo
K
23
1635
A-Line Advanced
K
23
0225
DynaFlex Clear Brackets & Buttons
K
22
2847
Ceramic Brackets Orthometric
K
22
2764
LightForce Orthodontic System
K
22
0689
Vatech Clismile
K
20
1410
VENUS Bracket, ROSE Bracket
K
20
1038
Luce Ceramic Bracket
K
20
0148
LightForce Orthodontic System (LFO System)
Show All 60 Submissions
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
/
NJM
/
K231635
View Source
A-Line Advanced
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K231635
510(k) Type
Traditional
Applicant
Biocetec Co., Ltd
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
6/6/2023
Days to Decision
1 days
Submission Type
Summary