| Device Classification Name |
Material, Tooth Shade, Resin
|
| 510(k) Number |
K260805 |
| Device Name |
Dual Core |
| Applicant |
| Vericom Co., Ltd. |
| 48,Toegyegongdan 1-Gil |
|
Chuncheon-Si,
KR
24427
|
|
| Applicant Contact |
Yun Ki Kim |
| Correspondent |
| LK Consulting Group USA, Inc. |
| 2552 Wanut Ave. Suite 230 |
|
Tustin,
CA
92780
|
|
| Correspondent Contact |
Priscilla Chung |
| Regulation Number | 872.3690 |
| Classification Product Code |
|
| Date Received | 03/12/2026 |
| Decision Date | 05/11/2026 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Dental
|
| 510k Review Panel |
Dental
|
| Summary |
Summary
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|