Device Classification Name |
Powder, Porcelain
|
510(k) Number |
K193055 |
Device Name |
Purzir Dental Zirconia |
Applicant |
3DBioCAD |
1525 N 4th St. |
Renton,
WA
98057
|
|
Applicant Contact |
Gyu D. Cho |
Correspondent |
EMERGO Global Consulting, LLC |
2500 Bee Cave Road |
Building 1, Suite 300 |
Austin,
TX
78746
|
|
Correspondent Contact |
Stuart R. Goldman |
Regulation Number | 872.6660
|
Classification Product Code |
|
Date Received | 11/01/2019 |
Decision Date | 05/13/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|