510k
Database
Specialties
Anesthesiology
527
Cardiovascular
1633
Chemistry
356
Dental
1304
Ear, Nose, Throat
239
Gastroenterology & Urology
946
General & Plastic Surgery
2157
General Hospital
2020
Hematology
126
Immunology
92
Medical Genetics
8
Microbiology
459
Neurology
948
Obstetrics & Gynecology
430
Ophthalmic
272
Orthopedic
2780
Pathology
52
Physical Medicine
515
Radiology
2364
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
407
LLZ
System, Image Processing,...
376
FXX
Mask, Surgical
357
GEX
Powered Laser Surgical Instrument
351
GEI
Electrosurgical, Cutting &...
297
QIH
Automated Radiological Image...
275
IYN
System, Imaging, Pulsed Doppler,...
272
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
220
NHA
Abutment, Implant, Dental,...
205
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Epien Medical, Inc.
Medical Device Manufacturer
·
US , Washington , DC
Epien Medical, Inc. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2013
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Epien Medical, Inc.
Dental
✕
2
devices
1-2 of 2
Filters
Cleared
Sep 09, 2021
EPIEN Dental Cleanser
K201785
·
KJJ
Dental
·
436d
Cleared
Feb 01, 2013
EPIEN ROOT CANAL CLEANSER
K123538
·
KJJ
Dental
·
77d
Filters
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2
Dental
2