510k
Database
Specialties
Anesthesiology
440
Cardiovascular
1340
Chemistry
331
Dental
1035
Ear, Nose, Throat
192
Gastroenterology & Urology
795
General & Plastic Surgery
1756
General Hospital
1163
Hematology
118
Immunology
84
Medical Genetics
7
Microbiology
414
Neurology
751
Obstetrics & Gynecology
331
Ophthalmic
204
Orthopedic
2398
Pathology
44
Physical Medicine
400
Radiology
1939
Toxicology
141
Categories
GEX
Powered Laser Surgical Instrument
286
LLZ
System, Image Processing,...
277
GEI
Electrosurgical, Cutting &...
249
QIH
Automated Radiological Image...
247
IYN
System, Imaging, Pulsed Doppler,...
237
HRS
Plate, Fixation, Bone
233
OLO
Orthopedic Stereotaxic Instrument
197
LZA
Polymer Patient Examination Glove
188
NHA
Abutment, Implant, Dental,...
184
MAX
Intervertebral Fusion Device...
165
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Dentsply Intl.
Medical Device Manufacturer
·
US , Walker , MI
Dentsply Intl. - FDA 510(k) Cleared Devices
279 submissions
·
279 cleared
·
Since 1976
279
Total
279
Cleared
0
Denied
FDA 510(k) Regulatory Record - Dentsply Intl.
Ophthalmic
✕
3
devices
1-3 of 3
Filters
Cleared
Oct 04, 1985
RELIANCE PENDULUM OPHTHALMIC DELIVERY SYSTEM
K853358
·
HMF
Ophthalmic
·
53d
Cleared
Sep 24, 1985
RELIANCE 1379
K853359
·
HRJ
Ophthalmic
·
43d
Cleared
Jan 30, 1978
SPECTACLE FRAME, OP-TITE
K772368
·
HQZ
Ophthalmic
·
34d
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All
279
Dental
260
Radiology
5
Orthopedic
4
Anesthesiology
3
Ophthalmic
3
General Hospital
2
Neurology
2