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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
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)
K
18
2672
ROSA Bracket
2
Cleared 510(K)
K
19
2202
Clear21
2
Cleared 510(K)
K
19
0608
Mei Ceramic Bracket
2
Cleared 510(K)
K
18
0952
Ceramic Bracket
2
Cleared 510(K)
K
18
2193
S-Line
2
Cleared 510(K)
K
18
3542
Signature Orthodontic System
2
Cleared 510(K)
K
18
1271
Signature Orthodontic System
2
Cleared 510(K)
K
18
0404
3M Clarity Ultra Self-Ligating Brackets and Adhesive Coated Appliance System
2
Cleared 510(K)
K
17
3440
Carriere SLX 3D Clear
2
Cleared 510(K)
K
17
2845
Symetri Clear
2
Cleared 510(K)
K
17
1844
Inspire ICE aka Inspire ICE Clear Brackets
2
Cleared 510(K)
K
16
3467
C-Line Orthodontic Ceramic Bracket
2
Cleared 510(K)
K
16
3117
Alpha Pure
2
Cleared 510(K)
K
16
0957
CDB Self Ligating Bracket 8F
2
Cleared 510(K)
K
16
0615
ORTHODONTIC CERAMIC BRACKETS 1.1
2
Cleared 510(K)
K
15
2167
BIJOU Orthodontic Ceramic Bracket
2
Cleared 510(K)
K
15
2779
Avex CX2
2
Cleared 510(K)
K
15
0141
Orthodontics Bracket
2
Cleared 510(K)
K
14
2729
Chi Lites Orthodontic Sapphire Bracket
2
Cleared 510(K)
K
14
1104
TRUKLEAR BRACKET
2
Cleared 510(K)
K
13
2368
VAPOR CERAMIC BRACKET
2
Cleared 510(K)
K
13
1197
EDGEWISE CERAMIC BRACKETS, ROTH CERAMIC BRACKETS
2
Cleared 510(K)
K
13
0446
FASTBRACES CERAMIC BRACKETS
2
Cleared 510(K)
K
12
3092
CERAMIN BRACKETS Z
2
Cleared 510(K)
K
12
2753
EMPOWER CLEAR
2
Cleared 510(K)
K
12
3094
ORTHODONTIC CERAMIC BRACKETS
2
Cleared 510(K)
K
12
0471
MACH BRACKETS BRIGHT BRACKETS
2
Cleared 510(K)
K
11
3334
AVEX CX2 AND AVEX CXI2 CERAMIC BRACKETS
2
Cleared 510(K)
K
11
2707
GENERATION C AESTHETIC SELF-LIGATING BRACKET SYSTEM
2
Cleared 510(K)
K
11
0335
CERAMIC BRACKETS
2
Cleared 510(K)
K
11
1234
CLICK-IT
2
Cleared 510(K)
K
10
2803
CLARITY ADVANCED CERAMIC BRACKETS
2
Cleared 510(K)
K
10
2561
ORTHODONTIC CERAMIC BRACKET
2
Cleared 510(K)
K
10
1481
BIOMERS TRANSLUCENT ORTHODONTIC BRACKET
2
Cleared 510(K)
K
09
1702
CDB FLIP-SIDE-CLIP BRACKET
2
Cleared 510(K)
K
09
0933
BERNHARD-FORSTER GMBH ORTHODONTIC CERAMIC BRACKETS
2
Cleared 510(K)
K
09
0567
ORTHODONTIC CERAMIC BRACKET
2
Cleared 510(K)
K
09
0454
ALLURE MB CERAMIC BRACKETS
2
Cleared 510(K)
K
08
2974
MYSTIQUE MB CERAMIC BRACKETS
2
Cleared 510(K)
K
08
0906
CDB CLIP
2
Cleared 510(K)
K
08
1415
DAMON 4CLEAR
2
Cleared 510(K)
K
08
0749
RADIANCE
2
Cleared 510(K)
K
07
3045
SAPPHIRE CERAMIC BRACKET
2
Cleared 510(K)
K
06
2305
CLARITY MODIFIED CERAMIC BRACKETS
2
Cleared 510(K)
K
06
0837
IN-OVATION C
2
Cleared 510(K)
K
05
2245
ACCENT AND EXCEED SERIES ORTHODONTIC CERAMIC BRACKETS
2
Cleared 510(K)
K
04
2905
NEO-CLIP ORTHODONTIC BRACKET ACCESSORY
2
Cleared 510(K)
K
04
2178
ORTHODONTIC CERAMIC BRACKETS
2
Cleared 510(K)
K
95
0992
CERAMAFLEX BRACKET SYSTEM
2
Cleared 510(K)
K
90
2075
INTRIGUE CERAMIC BRACKET
2
Cleared 510(K)
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
/
NJM
/
K123094
View Source
ORTHODONTIC CERAMIC BRACKETS
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K123094
510(k) Type
Traditional
Applicant
TOMY, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/13/2012
Days to Decision
72 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)
K
18
2672
ROSA Bracket
K
19
2202
Clear21
K
19
0608
Mei Ceramic Bracket
K
18
0952
Ceramic Bracket
K
18
2193
S-Line
K
18
3542
Signature Orthodontic System
K
18
1271
Signature Orthodontic System
K
18
0404
3M Clarity Ultra Self-Ligating Brackets and Adhesive Coated Appliance System
K
17
3440
Carriere SLX 3D Clear
K
17
2845
Symetri Clear
K
17
1844
Inspire ICE aka Inspire ICE Clear Brackets
K
16
3467
C-Line Orthodontic Ceramic Bracket
K
16
3117
Alpha Pure
K
16
0957
CDB Self Ligating Bracket 8F
K
16
0615
ORTHODONTIC CERAMIC BRACKETS 1.1
K
15
2167
BIJOU Orthodontic Ceramic Bracket
K
15
2779
Avex CX2
K
15
0141
Orthodontics Bracket
K
14
2729
Chi Lites Orthodontic Sapphire Bracket
K
14
1104
TRUKLEAR BRACKET
K
13
2368
VAPOR CERAMIC BRACKET
K
13
1197
EDGEWISE CERAMIC BRACKETS, ROTH CERAMIC BRACKETS
K
13
0446
FASTBRACES CERAMIC BRACKETS
K
12
3092
CERAMIN BRACKETS Z
K
12
2753
EMPOWER CLEAR
K
12
3094
ORTHODONTIC CERAMIC BRACKETS
K
12
0471
MACH BRACKETS BRIGHT BRACKETS
K
11
3334
AVEX CX2 AND AVEX CXI2 CERAMIC BRACKETS
K
11
2707
GENERATION C AESTHETIC SELF-LIGATING BRACKET SYSTEM
K
11
0335
CERAMIC BRACKETS
K
11
1234
CLICK-IT
K
10
2803
CLARITY ADVANCED CERAMIC BRACKETS
K
10
2561
ORTHODONTIC CERAMIC BRACKET
K
10
1481
BIOMERS TRANSLUCENT ORTHODONTIC BRACKET
K
09
1702
CDB FLIP-SIDE-CLIP BRACKET
K
09
0933
BERNHARD-FORSTER GMBH ORTHODONTIC CERAMIC BRACKETS
K
09
0567
ORTHODONTIC CERAMIC BRACKET
K
09
0454
ALLURE MB CERAMIC BRACKETS
K
08
2974
MYSTIQUE MB CERAMIC BRACKETS
K
08
0906
CDB CLIP
K
08
1415
DAMON 4CLEAR
K
08
0749
RADIANCE
K
07
3045
SAPPHIRE CERAMIC BRACKET
K
06
2305
CLARITY MODIFIED CERAMIC BRACKETS
K
06
0837
IN-OVATION C
K
05
2245
ACCENT AND EXCEED SERIES ORTHODONTIC CERAMIC BRACKETS
K
04
2905
NEO-CLIP ORTHODONTIC BRACKET ACCESSORY
K
04
2178
ORTHODONTIC CERAMIC BRACKETS
K
95
0992
CERAMAFLEX BRACKET SYSTEM
K
90
2075
INTRIGUE CERAMIC BRACKET
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
/
NJM
/
K123094
View Source
ORTHODONTIC CERAMIC BRACKETS
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K123094
510(k) Type
Traditional
Applicant
TOMY, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/13/2012
Days to Decision
72 days
Submission Type
Summary