510k
Database
Specialties
Anesthesiology
501
Cardiovascular
1553
Chemistry
354
Dental
1231
Ear, Nose, Throat
226
Gastroenterology & Urology
901
General & Plastic Surgery
2053
General Hospital
1635
Hematology
126
Immunology
91
Medical Genetics
8
Microbiology
441
Neurology
900
Obstetrics & Gynecology
400
Ophthalmic
262
Orthopedic
2646
Pathology
49
Physical Medicine
488
Radiology
2236
Toxicology
154
Categories
LLZ
System, Image Processing,...
338
GEX
Powered Laser Surgical Instrument
337
LZA
Polymer Patient Examination Glove
320
GEI
Electrosurgical, Cutting &...
288
QIH
Automated Radiological Image...
270
IYN
System, Imaging, Pulsed Doppler,...
261
HRS
Plate, Fixation, Bone
259
OLO
Orthopedic Stereotaxic Instrument
216
NHA
Abutment, Implant, Dental,...
204
MAX
Intervertebral Fusion Device...
193
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Orca Dental AI , Ltd.
Medical Device Manufacturer
·
IL , Ra'Anana
Orca Dental AI , Ltd. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2024
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Orca Dental AI , Ltd.
Radiology
✕
2
devices
1-2 of 2
Filters
Cleared
Mar 05, 2026
CEPHX3D
K252538
·
QIH
Radiology
·
205d
Cleared
Jan 31, 2024
CEPHX- Cephalometric Analysis Software
K231396
·
LLZ
Radiology
·
261d
Filters
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2
Radiology
2