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
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
K
24
0501
Spark™ Clear Aligner System
2
Cleared 510(K)
K
23
3356
Illusion Aligner Pro: Illusion Aligner FLX
2
Cleared 510(K)
K
24
1137
Clear Moves Aligner
2
Cleared 510(K)
K
24
1187
Alien Aligners
2
Cleared 510(K)
K
24
1412
Invisalign System
2
Cleared 510(K)
K
23
3935
DigiLine Direct Print Aligner System
2
Cleared 510(K)
K
24
0038
Clear Moves Aligners
2
Cleared 510(K)
K
23
2653
Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLX
2
Cleared 510(K)
K
24
0597
TERA HARZ CLEAR
2
Cleared 510(K)
K
23
3544
MESHEET
2
Cleared 510(K)
K
23
2074
Serafin®
2
Cleared 510(K)
K
23
2887
Invisalign Palatal Expander System
2
Cleared 510(K)
K
23
0199
Byte Aligner System
2
Cleared 510(K)
K
23
3257
3M™ Clarity™Aligners with Quick Attachments
2
Cleared 510(K)
K
23
2233
Invisalign System with Mandibular Advancement Featuring Occlusal Blocks
2
Cleared 510(K)
K
23
1884
TRIOCLEAR System
2
Cleared 510(K)
K
22
3517
Clear Aligner
2
Cleared 510(K)
K
23
1464
3M™ Clarity™ Aligners (3M™ Clarity™ Aligners-Force, 3M™ Clarity™ Aligners-Flex)
2
Cleared 510(K)
K
22
3141
STR8 Clear Aligner
2
Cleared 510(K)
K
22
3454
Custom-made Invisible Aligners
2
Cleared 510(K)
K
22
1537
Nightwear Aligners
2
Cleared 510(K)
K
22
2619
Ensmile
2
Cleared 510(K)
K
22
1845
Blue Sky Bio Aligner G & Blue Sky Plan S/W for Blue Sky Bio Aligner G
2
Cleared 510(K)
K
22
3338
Toothsi, Smilealigners
2
Cleared 510(K)
K
22
2894
Invisalign System, Pre-Formed Attachment System
2
Cleared 510(K)
K
22
2308
Al Smile Aligner
2
Cleared 510(K)
K
22
2918
DentCare Aligners
2
Cleared 510(K)
K
22
3355
Tera Harz Clear
2
Cleared 510(K)
K
21
1427
CREOKORREKT Aligners
2
Cleared 510(K)
K
22
2418
Nuvola
2
Cleared 510(K)
K
22
0140
ClearCorrect System
2
Cleared 510(K)
K
22
1475
MyClearALIGN Dental Aligner System
2
Cleared 510(K)
K
21
3026
Clear Aligner
2
Cleared 510(K)
K
22
0835
Arkligners
2
Cleared 510(K)
K
22
1097
SmileSeries
2
Cleared 510(K)
K
20
3624
Custom-made Invisible Aligners
2
Cleared 510(K)
K
21
2680
LuxCreo Clear Aligner System
2
Cleared 510(K)
K
21
2803
DailyMate Orthodontic Aligner System
2
Cleared 510(K)
K
22
0287
Invisalign System
2
Cleared 510(K)
K
22
0726
K Clear
2
Cleared 510(K)
K
21
1510
uLab Systems Dental Aligner Kit
2
Cleared 510(K)
K
21
3297
Redline
2
Cleared 510(K)
K
21
2772
Precision Align
2
Cleared 510(K)
K
21
2496
Ortho Aligner System
2
Cleared 510(K)
K
21
1537
QuickAligners
2
Cleared 510(K)
K
20
3688
Clear Aligner
2
Cleared 510(K)
K
21
0763
Inman Digital Clear Aligners
2
Cleared 510(K)
K
21
2660
Smylio Invisible Clear Aligners
2
Cleared 510(K)
K
21
2961
SMILERS
2
Cleared 510(K)
K
21
0373
Clear Aligners
2
Cleared 510(K)
K
21
0320
ClearCorrect System
2
Cleared 510(K)
K
19
3622
TRIOCLEAR System
2
Cleared 510(K)
K
21
0613
HIT Clear Aligner
2
Cleared 510(K)
K
21
0652
6MS Invisible Aligner
2
Cleared 510(K)
K
21
0540
Ohlendorf Clear Aligner
2
Cleared 510(K)
K
21
1010
Illusion Aligners
2
Cleared 510(K)
K
21
1190
3M Clarity Aligners (3M Clarity Aligners-Force, 3M Clarity Aligners-Flex)
2
Cleared 510(K)
K
20
3737
Spark Clear Aligner System
2
Cleared 510(K)
K
20
1104
AsoAligner
2
Cleared 510(K)
K
17
3738
Archworx
2
Cleared 510(K)
K
20
2792
BRIUS Clear Aligners
2
Cleared 510(K)
K
20
3339
NEOLab Clear Aligners
2
Cleared 510(K)
K
20
2857
ClearPath Aligner
2
Cleared 510(K)
K
20
0908
iSMILE
2
Cleared 510(K)
K
19
3385
TP Orthodontics Clear Aligner System
2
Cleared 510(K)
K
20
0005
Concinnity Aligners
2
Cleared 510(K)
K
20
2685
Eon Aligner
2
Cleared 510(K)
K
20
1450
Straight T Clear Dental Aligner
2
Cleared 510(K)
K
19
3130
MVP Aligner System
2
Cleared 510(K)
K
19
2244
Arcad SmileStudio and Aligner System
2
Cleared 510(K)
K
19
2069
Aerodentis System
2
Cleared 510(K)
K
19
1308
U-Aligner
2
Cleared 510(K)
K
19
1838
Clearform Aligners
2
Cleared 510(K)
K
19
2338
NEOLab Clear Aligners
2
Cleared 510(K)
K
20
0214
3D Predict
2
Cleared 510(K)
K
19
2596
ULab Systems Dental Aligner Kit
2
Cleared 510(K)
K
19
2846
Argen Clear Aligner, Argen Clear Aligner Premium
2
Cleared 510(K)
K
19
1837
UniSmile Clear Aligner System
2
Cleared 510(K)
K
19
2767
Clear Aligner
2
Cleared 510(K)
K
19
2470
DenMat Orthodontic Aligners
2
Cleared 510(K)
K
19
1823
Clear-Aligners
2
Cleared 510(K)
K
18
2388
Krystal Klear Aligners
2
Cleared 510(K)
K
19
0394
SunClear Aligner system
2
Cleared 510(K)
K
19
0003
Vivid Aligners
2
Cleared 510(K)
K
19
1774
SmileAlign Orthodontic Aligner System
2
Cleared 510(K)
K
19
2119
3M Clarity Aligners
2
Cleared 510(K)
K
19
1990
OSW Aligner System
2
Cleared 510(K)
K
19
0583
DynaFlex
2
Cleared 510(K)
K
18
2658
Bioliner
2
Cleared 510(K)
K
18
3229
Argen Clear Aligner
2
Cleared 510(K)
K
19
0948
Magic Clear Aligners
2
Cleared 510(K)
K
18
1747
Orthodontic Appliance
2
Cleared 510(K)
K
18
0346
Byte Aligner System
2
Cleared 510(K)
K
18
0648
Park Dental Research Aligners
2
Cleared 510(K)
K
18
3643
Clear Image Aligners
2
Cleared 510(K)
K
18
3159
3M Clarity Aligners
2
Cleared 510(K)
K
18
2329
SureCure Orthodontic Aligner System
2
Cleared 510(K)
K
18
1739
Invisalign System with Mandibular Advancement Feature
2
Cleared 510(K)
K
18
2826
Ormco Spark Aligner System
2
Cleared 510(K)
K
18
0241
Orthocaps Twinaligner
2
Cleared 510(K)
K
17
3784
Smylic Invisible Clear Aligners
2
Cleared 510(K)
K
17
2765
Smart Moves Complete
2
Cleared 510(K)
K
17
3785
Custom Clear Aligner System
2
Cleared 510(K)
K
18
0107
Blue Sky Bio Aligner
2
Cleared 510(K)
K
17
1674
Angel Align System
2
Cleared 510(K)
K
17
1860
Sureclear aligners
2
Cleared 510(K)
K
16
2609
ClearPath Aligner
2
Cleared 510(K)
K
16
3155
MTM Clear Aligner
2
Cleared 510(K)
K
16
3689
3M Clear Tray Aligner
2
Cleared 510(K)
K
15
1965
Dentti System
2
Cleared 510(K)
K
14
3630
Invisalign System
2
Cleared 510(K)
K
14
3499
eCligner
2
Cleared 510(K)
K
12
3514
CLEARPATH ALIGNER
2
Cleared 510(K)
K
13
2145
MTM(R) CLEAR ALIGNER
2
Cleared 510(K)
K
12
3925
MTM CLEAR ALIGNER IN-OFFICE
2
Cleared 510(K)
K
13
0237
PONTIC PAINT
2
Cleared 510(K)
K
12
1396
DYNAFLEX
2
Cleared 510(K)
K
11
3618
CLEARCORRECT SYSTEM
2
Cleared 510(K)
K
09
3821
FS ALIGNER
2
Cleared 510(K)
K
07
3121
NUBRACE INVISIBLE REMOVABLE ORTHODONTICS
2
Cleared 510(K)
K
08
2556
CLEARCORRECT
2
Cleared 510(K)
K
08
1960
INVISALIGN SYSTEM
2
Cleared 510(K)
K
08
0246
COMPOSITE ALIGNER BUTTON
2
Cleared 510(K)
K
07
1970
CLEAR IMAGE ALIGNER
2
Cleared 510(K)
K
04
0874
RED, WHITE & BLUE
2
Cleared 510(K)
K
98
1095
ALIGN SYSTEM
2
Cleared 510(K)
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 30 November 2024 at 11:09 am
DE
/
subpart-f—therapeutic-devices
/
NXC
/
K082556
View Source
CLEARCORRECT
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K082556
510(k) Type
Traditional
Applicant
CLEARCORRECT, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/6/2009
Days to Decision
155 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
NLC
Bracket, Plastic, Orthodontic, Reprocessed
NQS
Bracket, Metal, Orthodontic, Reprocessed
NTO
Rinse, Oral, Antibacterial (By Physical Means)
NXC
Aligner, Sequential
K
24
0501
Spark™ Clear Aligner System
K
23
3356
Illusion Aligner Pro: Illusion Aligner FLX
K
24
1137
Clear Moves Aligner
K
24
1187
Alien Aligners
K
24
1412
Invisalign System
K
23
3935
DigiLine Direct Print Aligner System
K
24
0038
Clear Moves Aligners
K
23
2653
Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLX
K
24
0597
TERA HARZ CLEAR
K
23
3544
MESHEET
K
23
2074
Serafin®
K
23
2887
Invisalign Palatal Expander System
K
23
0199
Byte Aligner System
K
23
3257
3M™ Clarity™Aligners with Quick Attachments
K
23
2233
Invisalign System with Mandibular Advancement Featuring Occlusal Blocks
K
23
1884
TRIOCLEAR System
K
22
3517
Clear Aligner
K
23
1464
3M™ Clarity™ Aligners (3M™ Clarity™ Aligners-Force, 3M™ Clarity™ Aligners-Flex)
K
22
3141
STR8 Clear Aligner
K
22
3454
Custom-made Invisible Aligners
K
22
1537
Nightwear Aligners
K
22
2619
Ensmile
K
22
1845
Blue Sky Bio Aligner G & Blue Sky Plan S/W for Blue Sky Bio Aligner G
K
22
3338
Toothsi, Smilealigners
K
22
2894
Invisalign System, Pre-Formed Attachment System
K
22
2308
Al Smile Aligner
K
22
2918
DentCare Aligners
K
22
3355
Tera Harz Clear
K
21
1427
CREOKORREKT Aligners
K
22
2418
Nuvola
K
22
0140
ClearCorrect System
K
22
1475
MyClearALIGN Dental Aligner System
K
21
3026
Clear Aligner
K
22
0835
Arkligners
K
22
1097
SmileSeries
K
20
3624
Custom-made Invisible Aligners
K
21
2680
LuxCreo Clear Aligner System
K
21
2803
DailyMate Orthodontic Aligner System
K
22
0287
Invisalign System
K
22
0726
K Clear
K
21
1510
uLab Systems Dental Aligner Kit
K
21
3297
Redline
K
21
2772
Precision Align
K
21
2496
Ortho Aligner System
K
21
1537
QuickAligners
K
20
3688
Clear Aligner
K
21
0763
Inman Digital Clear Aligners
K
21
2660
Smylio Invisible Clear Aligners
K
21
2961
SMILERS
K
21
0373
Clear Aligners
K
21
0320
ClearCorrect System
K
19
3622
TRIOCLEAR System
K
21
0613
HIT Clear Aligner
K
21
0652
6MS Invisible Aligner
K
21
0540
Ohlendorf Clear Aligner
K
21
1010
Illusion Aligners
K
21
1190
3M Clarity Aligners (3M Clarity Aligners-Force, 3M Clarity Aligners-Flex)
K
20
3737
Spark Clear Aligner System
K
20
1104
AsoAligner
K
17
3738
Archworx
K
20
2792
BRIUS Clear Aligners
K
20
3339
NEOLab Clear Aligners
K
20
2857
ClearPath Aligner
K
20
0908
iSMILE
K
19
3385
TP Orthodontics Clear Aligner System
K
20
0005
Concinnity Aligners
K
20
2685
Eon Aligner
K
20
1450
Straight T Clear Dental Aligner
K
19
3130
MVP Aligner System
K
19
2244
Arcad SmileStudio and Aligner System
K
19
2069
Aerodentis System
K
19
1308
U-Aligner
K
19
1838
Clearform Aligners
K
19
2338
NEOLab Clear Aligners
K
20
0214
3D Predict
K
19
2596
ULab Systems Dental Aligner Kit
K
19
2846
Argen Clear Aligner, Argen Clear Aligner Premium
K
19
1837
UniSmile Clear Aligner System
K
19
2767
Clear Aligner
K
19
2470
DenMat Orthodontic Aligners
K
19
1823
Clear-Aligners
K
18
2388
Krystal Klear Aligners
K
19
0394
SunClear Aligner system
K
19
0003
Vivid Aligners
K
19
1774
SmileAlign Orthodontic Aligner System
K
19
2119
3M Clarity Aligners
K
19
1990
OSW Aligner System
K
19
0583
DynaFlex
K
18
2658
Bioliner
K
18
3229
Argen Clear Aligner
K
19
0948
Magic Clear Aligners
K
18
1747
Orthodontic Appliance
K
18
0346
Byte Aligner System
K
18
0648
Park Dental Research Aligners
K
18
3643
Clear Image Aligners
K
18
3159
3M Clarity Aligners
K
18
2329
SureCure Orthodontic Aligner System
K
18
1739
Invisalign System with Mandibular Advancement Feature
K
18
2826
Ormco Spark Aligner System
K
18
0241
Orthocaps Twinaligner
K
17
3784
Smylic Invisible Clear Aligners
K
17
2765
Smart Moves Complete
K
17
3785
Custom Clear Aligner System
K
18
0107
Blue Sky Bio Aligner
K
17
1674
Angel Align System
K
17
1860
Sureclear aligners
K
16
2609
ClearPath Aligner
K
16
3155
MTM Clear Aligner
K
16
3689
3M Clear Tray Aligner
K
15
1965
Dentti System
K
14
3630
Invisalign System
K
14
3499
eCligner
K
12
3514
CLEARPATH ALIGNER
K
13
2145
MTM(R) CLEAR ALIGNER
K
12
3925
MTM CLEAR ALIGNER IN-OFFICE
K
13
0237
PONTIC PAINT
K
12
1396
DYNAFLEX
K
11
3618
CLEARCORRECT SYSTEM
K
09
3821
FS ALIGNER
K
07
3121
NUBRACE INVISIBLE REMOVABLE ORTHODONTICS
K
08
2556
CLEARCORRECT
K
08
1960
INVISALIGN SYSTEM
K
08
0246
COMPOSITE ALIGNER BUTTON
K
07
1970
CLEAR IMAGE ALIGNER
K
04
0874
RED, WHITE & BLUE
K
98
1095
ALIGN SYSTEM
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
/
NXC
/
K082556
View Source
CLEARCORRECT
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K082556
510(k) Type
Traditional
Applicant
CLEARCORRECT, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/6/2009
Days to Decision
155 days
Submission Type
Summary