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
EAS
Gel, Electrode, For Pulp Tester
1
Product Code
EAT
Tester, Pulp
2
Product Code
EGZ
Holder, Film, X-Ray
1
Product Code
EHA
Aligner, Beam, X-Ray
1
Product Code
JEO
Measurer, Gingival Fluid
1
Product Code
LFC
Device, Caries Detection
2
Product Code
MVH
Device, Detection, Sulfide
2
Product Code
NBL
Laser, Fluorescence Caries Detection
2
Product Code
NFP
Device, Dental Sonography, For Diagnosis Of Tmj / Mpd Disorders
2
Product Code
NFQ
Device, Dental Sonography, For Monitoring Jaw Sounds
1
Product Code
NFR
Device, Jaw Tracking, For Diagnosis Of Tmj / Mpd Disorders
2
Product Code
NFS
Device, Jaw Tracking, For Monitoring Jaw Positions
1
Product Code
NTK
Caries Detector, Laser Light, Transmission
2
Product Code
K
24
0573
iTero Lumina™ Pro
2
Cleared 510(K)
K
21
3482
TIA Tip, Cariosity, Transillumination Accessory Tip
2
Cleared 510(K)
K
19
3659
iTero Element 5D
2
Cleared 510(K)
K
18
2712
DEXIS CariVu 3-in-1 by KaVo
2
Cleared 510(K)
K
17
2007
CamX Triton HD Proxi Head
2
Cleared 510(K)
K
12
3402
DIAGNOCAM
2
Cleared 510(K)
K
07
1429
TI2200 TRANSILLUMINATION CABLE
2
Cleared 510(K)
K
06
2961
MICROLUX TRANSILLUMINATOR
2
Cleared 510(K)
K
06
0080
DIAGNODENT 2190 WITH PERIODONTAL PROBE
2
Cleared 510(K)
K
04
3068
DIFOTI USB 2.0 SYSTEM
2
Cleared 510(K)
NYH
Plaque Disclosing Kit
2
Product Code
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
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 6 December 2024 at 11:05 pm
DE
/
subpart-b—diagnostic-devices
/
NTK
/
K240573
View Source
iTero Lumina™ Pro
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K240573
510(k) Type
Traditional
Applicant
Align Technology Ltd.
Country
Israel
FDA Decision
Substantially Equivalent
Decision Date
8/16/2024
Days to Decision
168 days
Submission Type
Summary
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Miscellaneous
Subpart B—Diagnostic Devices
EAS
Gel, Electrode, For Pulp Tester
EAT
Tester, Pulp
EGZ
Holder, Film, X-Ray
EHA
Aligner, Beam, X-Ray
JEO
Measurer, Gingival Fluid
LFC
Device, Caries Detection
MVH
Device, Detection, Sulfide
NBL
Laser, Fluorescence Caries Detection
NFP
Device, Dental Sonography, For Diagnosis Of Tmj / Mpd Disorders
NFQ
Device, Dental Sonography, For Monitoring Jaw Sounds
NFR
Device, Jaw Tracking, For Diagnosis Of Tmj / Mpd Disorders
NFS
Device, Jaw Tracking, For Monitoring Jaw Positions
NTK
Caries Detector, Laser Light, Transmission
K
24
0573
iTero Lumina™ Pro
K
21
3482
TIA Tip, Cariosity, Transillumination Accessory Tip
K
19
3659
iTero Element 5D
K
18
2712
DEXIS CariVu 3-in-1 by KaVo
K
17
2007
CamX Triton HD Proxi Head
K
12
3402
DIAGNOCAM
K
07
1429
TI2200 TRANSILLUMINATION CABLE
K
06
2961
MICROLUX TRANSILLUMINATOR
K
06
0080
DIAGNODENT 2190 WITH PERIODONTAL PROBE
K
04
3068
DIFOTI USB 2.0 SYSTEM
NYH
Plaque Disclosing Kit
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
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-b—diagnostic-devices
/
NTK
/
K240573
View Source
iTero Lumina™ Pro
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K240573
510(k) Type
Traditional
Applicant
Align Technology Ltd.
Country
Israel
FDA Decision
Substantially Equivalent
Decision Date
8/16/2024
Days to Decision
168 days
Submission Type
Summary