510k
Database
Specialties
Anesthesiology
136
Cardiovascular
572
Chemistry
165
Dental
321
Ear, Nose, Throat
68
Gastroenterology & Urology
291
General & Plastic Surgery
528
General Hospital
379
Hematology
67
Immunology
58
Medical Genetics
0
Microbiology
234
Neurology
173
Obstetrics & Gynecology
62
Ophthalmic
51
Orthopedic
1297
Pathology
18
Physical Medicine
88
Radiology
877
Toxicology
88
Categories
IYN
System, Imaging, Pulsed Doppler,...
152
HRS
Plate, Fixation, Bone
134
OLO
Orthopedic Stereotaxic Instrument
117
LLZ
System, Image Processing,...
100
NHA
Abutment, Implant, Dental,...
86
MBI
Fastener, Fixation,...
85
MAX
Intervertebral Fusion Device...
84
LNH
System, Nuclear Magnetic...
83
NKB
Thoracolumbosacral Pedicle Screw...
81
JAK
System, X-ray, Tomography, Computed
79
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Envisiontec GmbH
Medical Device Manufacturer
·
DE , Gladbeck
Envisiontec GmbH - FDA 510(k) Cleared Devices
5 submissions
·
5 cleared
·
Since 2020
5
Total
5
Cleared
0
Denied
FDA 510(k) cleared devices by Envisiontec GmbH
Dental
✕
5
devices
1-5 of 5
Filters
Cleared
Jun 10, 2022
SmileGuard
K220894
·
MQC
Dental
·
74d
Cleared
Jun 14, 2021
E-Temp
K211101
·
EBG
Dental
·
62d
Cleared
May 25, 2021
E-Dent 1000
K210977
·
EBF
Dental
·
54d
Cleared
Mar 30, 2021
E-Denture Pro
K203641
·
EBI
Dental
·
106d
Cleared
Nov 27, 2020
E-Guard
K201173
·
MQC
Dental
·
210d
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5
Dental
5