510k
Database
Specialties
Anesthesiology
548
Cardiovascular
1719
Chemistry
381
Dental
1367
Ear, Nose, Throat
252
Gastroenterology & Urology
982
General & Plastic Surgery
2217
General Hospital
2088
Hematology
126
Immunology
101
Medical Genetics
8
Microbiology
474
Neurology
980
Obstetrics & Gynecology
441
Ophthalmic
283
Orthopedic
3046
Pathology
52
Physical Medicine
515
Radiology
2492
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
416
LLZ
System, Image Processing,...
401
GEX
Powered Laser Surgical Instrument
363
FXX
Mask, Surgical
359
GEI
Electrosurgical, Cutting &...
307
IYN
System, Imaging, Pulsed Doppler,...
304
HRS
Plate, Fixation, Bone
297
QIH
Automated Radiological Image...
277
OLO
Orthopedic Stereotaxic Instrument
236
MAX
Intervertebral Fusion Device...
233
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Datum Dental, Ltd.
Medical Device Manufacturer
·
IL , Lod
Datum Dental, Ltd. - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2016
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Datum Dental, Ltd.
Dental
✕
4
devices
1-4 of 4
Filters
Cleared
Jul 18, 2022
OSSIX Breeze
K212509
·
NPL
Dental
·
343d
Cleared
Jul 18, 2017
OSSIX BONE
K163714
·
NPM
Dental
·
200d
Cleared
Aug 04, 2016
OSSIX VOLUMAX
K153549
·
NPL
Dental
·
237d
Cleared
Aug 04, 2016
OSSIX PLUS
K160281
·
NPL
Dental
·
184d
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4
Dental
4