510k
Database
Specialties
Anesthesiology
385
Cardiovascular
1200
Chemistry
294
Dental
892
Ear, Nose, Throat
165
Gastroenterology & Urology
707
General & Plastic Surgery
1521
General Hospital
902
Hematology
109
Immunology
78
Medical Genetics
1
Microbiology
392
Neurology
662
Obstetrics & Gynecology
284
Ophthalmic
176
Orthopedic
2191
Pathology
42
Physical Medicine
356
Radiology
1749
Toxicology
137
Categories
GEX
Powered Laser Surgical Instrument
253
QIH
Automated Radiological Image...
231
LLZ
System, Image Processing,...
227
IYN
System, Imaging, Pulsed Doppler,...
221
HRS
Plate, Fixation, Bone
217
GEI
Electrosurgical, Cutting &...
211
OLO
Orthopedic Stereotaxic Instrument
182
NHA
Abutment, Implant, Dental,...
169
NKB
Thoracolumbosacral Pedicle Screw...
149
MAX
Intervertebral Fusion Device...
146
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Sirona Dental Systems GmbH
Medical Device Manufacturer
·
US , N. Attleboro , MA
Sirona Dental Systems GmbH - FDA 510(k) Cleared Devices
42 submissions
·
42 cleared
·
Since 1998
42
Total
42
Cleared
0
Denied
FDA 510(k) Regulatory Record - Sirona Dental Systems GmbH
General & Plastic Surgery
✕
3
devices
1-3 of 3
Filters
Cleared
Feb 15, 2011
SIROLASER ADVANCE, SIROLASER XTEND, SIROLASER XTEND UPGRADED, FONALASER
K103753
·
GEX
General & Plastic Surgery
·
54d
Cleared
Dec 03, 2009
SIROLASER ADVANCE
K092660
·
GEX
General & Plastic Surgery
·
97d
Cleared
Jan 18, 2006
SIROLASER
K053161
·
GEX
General & Plastic Surgery
·
65d
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42
Dental
25
Radiology
14
General & Plastic Surgery
3