Device Classification Name |
aligner, sequential
|
510(k) Number |
K223355 |
Device Name |
Tera Harz Clear |
Applicant |
Graphy Inc. |
603, #617, Ace Gasan Forhu, 225, Gasan digital 1-ro, |
Geumcheon-gu, |
Seoul,
KR
08503
|
|
Applicant Contact |
Moon Soo Part |
Correspondent |
THIRD PARTY REVIEW GROUP, LLC |
25 Independence Blvd |
Warren,
NJ
07059
|
|
Correspondent Contact |
Dave Yungvirt |
Regulation Number | 872.5470
|
Classification Product Code |
|
Date Received | 11/02/2022 |
Decision Date | 11/03/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|