510k
Database
Specialties
Anesthesiology
525
Cardiovascular
1613
Chemistry
356
Dental
1304
Ear, Nose, Throat
235
Gastroenterology & Urology
930
General & Plastic Surgery
2136
General Hospital
1991
Hematology
126
Immunology
91
Medical Genetics
8
Microbiology
449
Neurology
942
Obstetrics & Gynecology
429
Ophthalmic
272
Orthopedic
2705
Pathology
52
Physical Medicine
515
Radiology
2353
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
403
LLZ
System, Image Processing,...
373
FXX
Mask, Surgical
357
GEX
Powered Laser Surgical Instrument
351
GEI
Electrosurgical, Cutting &...
295
QIH
Automated Radiological Image...
275
IYN
System, Imaging, Pulsed Doppler,...
271
HRS
Plate, Fixation, Bone
263
OLO
Orthopedic Stereotaxic Instrument
218
NHA
Abutment, Implant, Dental,...
205
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Dent4you AG
Medical Device Manufacturer
·
CH , Heerbrugg
Dent4you AG - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2022
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Dent4you AG
Dental
✕
4
devices
1-4 of 4
Filters
Cleared
Jun 27, 2025
JET BITE
K250969
·
ELW
Dental
·
88d
Cleared
Nov 15, 2024
Speedex Light Body
K242360
·
ELW
Dental
·
98d
Cleared
Jul 01, 2024
BioSonic US200 Ultrasonic Scaler (60034537)
K240801
·
ELC
Dental
·
98d
Cleared
Dec 22, 2022
Coltolux Comfort LED Curing Light
K223142
·
EBZ
Dental
·
79d
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4
Dental
4