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
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
K
23
3625
RAYDENT SW
2
Cleared 510(K)
K
23
2564
Align Studio
2
Cleared 510(K)
K
23
3616
Clevaligner Software (V1.0.0)
2
Cleared 510(K)
K
23
2549
NemoCast
2
Cleared 510(K)
K
23
2429
Titan Dental Design
2
Cleared 510(K)
K
22
3518
iOrtho
2
Cleared 510(K)
K
21
2173
HDH Treatment Planning System
2
Cleared 510(K)
K
21
2770
Vision
2
Cleared 510(K)
K
21
3916
ArchForm Orthodontic Software System
2
Cleared 510(K)
K
21
2828
BRIUS Planner Software
2
Cleared 510(K)
K
20
3442
Inbrace Orthodontic System
2
Cleared 510(K)
K
20
1036
PlaniMax Orthodontic Software
2
Cleared 510(K)
K
19
2847
AUTOLIGN
2
Cleared 510(K)
K
20
0772
ULab Systems uDesign Software
2
Cleared 510(K)
K
19
3003
NemoCast
2
Cleared 510(K)
K
19
2701
DIBS (Digital Indirect Bonding System)
2
Cleared 510(K)
K
19
1720
BRUIS Software Suite
2
Cleared 510(K)
K
19
3390
CS Model+
2
Cleared 510(K)
K
19
1911
3Shape Splint Design
2
Cleared 510(K)
K
18
3695
OrthoAnalysis Software
2
Cleared 510(K)
K
18
1112
Orchestrate 3D
2
Cleared 510(K)
K
18
0941
Ortho System
2
Cleared 510(K)
K
17
1634
Ortho System
2
Cleared 510(K)
K
17
1122
CEREC Ortho Software
2
Cleared 510(K)
K
17
1295
ULab Systems Treatment Planning Software
2
Cleared 510(K)
K
16
3677
Ortho System
2
Cleared 510(K)
K
16
2850
GuideMia Ortho+
2
Cleared 510(K)
K
15
2086
3Shape Ortho System
2
Cleared 510(K)
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
/
PNN
/
K193390
View Source
CS Model+
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K193390
510(k) Type
Traditional
Applicant
Trophy
Country
France
FDA Decision
Substantially Equivalent
Decision Date
4/2/2020
Days to Decision
118 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
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
K
23
3625
RAYDENT SW
K
23
2564
Align Studio
K
23
3616
Clevaligner Software (V1.0.0)
K
23
2549
NemoCast
K
23
2429
Titan Dental Design
K
22
3518
iOrtho
K
21
2173
HDH Treatment Planning System
K
21
2770
Vision
K
21
3916
ArchForm Orthodontic Software System
K
21
2828
BRIUS Planner Software
K
20
3442
Inbrace Orthodontic System
K
20
1036
PlaniMax Orthodontic Software
K
19
2847
AUTOLIGN
K
20
0772
ULab Systems uDesign Software
K
19
3003
NemoCast
K
19
2701
DIBS (Digital Indirect Bonding System)
K
19
1720
BRUIS Software Suite
K
19
3390
CS Model+
K
19
1911
3Shape Splint Design
K
18
3695
OrthoAnalysis Software
K
18
1112
Orchestrate 3D
K
18
0941
Ortho System
K
17
1634
Ortho System
K
17
1122
CEREC Ortho Software
K
17
1295
ULab Systems Treatment Planning Software
K
16
3677
Ortho System
K
16
2850
GuideMia Ortho+
K
15
2086
3Shape Ortho System
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
/
PNN
/
K193390
View Source
CS Model+
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K193390
510(k) Type
Traditional
Applicant
Trophy
Country
France
FDA Decision
Substantially Equivalent
Decision Date
4/2/2020
Days to Decision
118 days
Submission Type
Summary