510k
Database
Specialties
Anesthesiology
133
Cardiovascular
568
Chemistry
163
Dental
313
Ear, Nose, Throat
68
Gastroenterology & Urology
287
General & Plastic Surgery
515
General Hospital
372
Hematology
67
Immunology
56
Medical Genetics
0
Microbiology
232
Neurology
165
Obstetrics & Gynecology
61
Ophthalmic
49
Orthopedic
1292
Pathology
18
Physical Medicine
85
Radiology
868
Toxicology
88
Categories
IYN
System, Imaging, Pulsed Doppler,...
150
HRS
Plate, Fixation, Bone
134
OLO
Orthopedic Stereotaxic Instrument
117
LLZ
System, Image Processing,...
100
MBI
Fastener, Fixation,...
85
NHA
Abutment, Implant, Dental,...
84
LNH
System, Nuclear Magnetic...
83
MAX
Intervertebral Fusion Device...
83
NKB
Thoracolumbosacral Pedicle Screw...
81
JAK
System, X-ray, Tomography, Computed
79
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Pac-Dent, Inc.
Medical Device Manufacturer
·
US , Brea , CA
Pac-Dent, Inc. - FDA 510(k) Cleared Devices
8 submissions
·
8 cleared
·
Since 2020
8
Total
8
Cleared
0
Denied
FDA 510(k) cleared devices by Pac-Dent, Inc.
General Hospital
✕
2
devices
1-2 of 2
Filters
Cleared
Aug 26, 2021
The iMask Child's Face Mask
K202831
·
OXZ
General Hospital
·
335d
Cleared
Feb 19, 2021
iMask Disposable Surgical Face Mask
K201182
·
FXX
General Hospital
·
294d
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8
Dental
6
General Hospital
2