510k
Database
Specialties
Anesthesiology
527
Cardiovascular
1634
Chemistry
356
Dental
1304
Ear, Nose, Throat
239
Gastroenterology & Urology
946
General & Plastic Surgery
2157
General Hospital
2020
Hematology
126
Immunology
92
Medical Genetics
8
Microbiology
459
Neurology
948
Obstetrics & Gynecology
430
Ophthalmic
272
Orthopedic
2795
Pathology
52
Physical Medicine
515
Radiology
2368
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
407
LLZ
System, Image Processing,...
376
FXX
Mask, Surgical
357
GEX
Powered Laser Surgical Instrument
351
GEI
Electrosurgical, Cutting &...
297
IYN
System, Imaging, Pulsed Doppler,...
276
QIH
Automated Radiological Image...
275
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
220
NHA
Abutment, Implant, Dental,...
205
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Graphy, Inc.
Medical Device Manufacturer
·
KR , Seoul
Graphy, Inc. - FDA 510(k) Cleared Devices
6 submissions
·
6 cleared
·
Since 2021
6
Total
6
Cleared
0
Denied
FDA 510(k) Regulatory Record - Graphy, Inc.
Dental
✕
6
devices
1-6 of 6
Filters
Cleared
Nov 21, 2025
TERA HARZ Hard Denture (THD-C-500)
K253681
·
EBI
Dental
Cleared
Mar 05, 2024
TERA HARZ CLEAR
K240597
·
NXC
Dental
·
1d
Cleared
Nov 01, 2023
TERA HARZ II
K233502
·
EBF
Dental
·
1d
Cleared
Nov 03, 2022
Tera Harz Clear
K223355
·
NXC
Dental
·
1d
Cleared
Aug 11, 2022
TERA HARZ DENTURE
K222414
·
EBI
Dental
·
1d
Cleared
Jul 15, 2021
TERA HARZ
K202846
·
EBF
Dental
·
293d
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6
Dental
6