510k
Database
Specialties
Anesthesiology
525
Cardiovascular
1613
Chemistry
356
Dental
1304
Ear, Nose, Throat
235
Gastroenterology & Urology
930
General & Plastic Surgery
2136
General Hospital
1991
Hematology
126
Immunology
91
Medical Genetics
8
Microbiology
449
Neurology
942
Obstetrics & Gynecology
429
Ophthalmic
272
Orthopedic
2729
Pathology
52
Physical Medicine
515
Radiology
2353
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
403
LLZ
System, Image Processing,...
373
FXX
Mask, Surgical
357
GEX
Powered Laser Surgical Instrument
351
GEI
Electrosurgical, Cutting &...
295
QIH
Automated Radiological Image...
275
IYN
System, Imaging, Pulsed Doppler,...
271
HRS
Plate, Fixation, Bone
264
OLO
Orthopedic Stereotaxic Instrument
218
NHA
Abutment, Implant, Dental,...
205
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Saremco Dental AG
Medical Device Manufacturer
·
CH , Rebstein
Saremco Dental AG - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2022
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Saremco Dental AG
Dental
✕
4
devices
1-4 of 4
Filters
Cleared
Dec 05, 2025
els unibond
K252151
·
KLE
Dental
·
149d
Cleared
Jun 27, 2024
els extra low shrinkage® composite & els extra low shrinkage® flow
K240823
·
EBF
Dental
·
93d
Cleared
Nov 14, 2023
saremco print BRIDGETEC
K232050
·
EBF
Dental
·
127d
Cleared
Jan 21, 2022
Saremco Print CROWNTEC
K213343
·
EBF
Dental
·
106d
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4
Dental
4