Medical Device Manufacturer · KR , Seoul

Graphy, Inc.

6 submissions · 6 cleared · Since 2021
6
Total
6
Cleared
0
Denied

Graphy, Inc. — FDA 510(k) Submissions

Graphy, Inc. has submitted 6 FDA 510(k) premarket notifications since 2021, of which 6 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Material, Tooth Shade, Resin, Resin, Denture, Relining, Repairing, Rebasing, Aligner, Sequential . Use the specialty filter in the sidebar to narrow results.

6 devices
1–6 of 6
TERA HARZ Hard Denture (THD-C-500); TERA HARZ Hard Denture (THD-C-1000); TERA HARZ Hard Denture (THD-LP-500); TERA HARZ Hard Denture (THD-LP-1000); TERA HARZ Hard Denture (THD-P-500); TERA HARZ Hard Denture (THD-P-1000); TERA HARZ Hard Denture (THD-CP-500); TERA HARZ Hard Denture (THD-CP-1000)
K253681 · EBI Resin, Denture, Relining,... · Dental
Nov 2025
TERA HARZ CLEAR
K240597 · NXC Aligner, Sequential · Dental
Mar 2024 1d
TERA HARZ II
K233502 · EBF Material, Tooth Shade, Resin · Dental
Nov 2023 1d
Tera Harz Clear
K223355 · NXC Aligner, Sequential · Dental
Nov 2022 1d
TERA HARZ DENTURE
K222414 · EBI Resin, Denture, Relining,... · Dental
Aug 2022 1d
TERA HARZ
K202846 · EBF Material, Tooth Shade, Resin · Dental
Jul 2021 293d
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