Device Classification Name |
Crown And Bridge, Temporary, Resin
|
510(k) Number |
K201563 |
Device Name |
PuRE PMMA Disc |
Applicant |
Quest Dental USA Corp. |
17865 Sky Park Circle, Suite L1 |
Irvine,
CA
92614
|
|
Applicant Contact |
Hirotaka Mori |
Correspondent |
Globizz Corporation |
1411 W. 190th Street Suite 200 |
Gardena,
CA
90248
|
|
Correspondent Contact |
Takahiro Haruyama |
Regulation Number | 872.3770
|
Classification Product Code |
|
Date Received | 06/10/2020 |
Decision Date | 04/09/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|