Device Classification Name |
powder, porcelain
|
510(k) Number |
K232682 |
Device Name |
Pre-Sintered Zirconia Coloring Liquid |
Applicant |
Chengdu Besmile Medical Technology Co., Ltd. |
No.9, Sec.2, Shengwucheng North Rd., Chengdu Tianfu |
International Bio-Town, Shuangliu District |
Chengdu,
CN
|
|
Applicant Contact |
Moushan Liu |
Correspondent |
Chengdu Besmile Medical Technology Co., Ltd. |
No.9, Sec.2, Shengwucheng North Rd., Chengdu Tianfu |
International Bio-Town, Shuangliu District |
Chengdu,
CN
610200
|
|
Correspondent Contact |
Moushan Liu |
Regulation Number | 872.6660
|
Classification Product Code |
|
Date Received | 09/01/2023 |
Decision Date | 03/19/2024 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|