Device Classification Name |
Powder, Porcelain
|
510(k) Number |
K220816 |
Device Name |
BruxZir NOW |
Applicant |
Prismatik Dentalcraft, Inc. |
2144 Michelson Drive |
Irvine,
CA
96212
|
|
Applicant Contact |
So Hyun Park |
Correspondent |
Prismatik Dentalcraft, Inc. |
2144 Michelson Drive |
Irvine,
CA
96212
|
|
Correspondent Contact |
So Hyun Park |
Regulation Number | 872.6660
|
Classification Product Code |
|
Date Received | 03/21/2022 |
Decision Date | 08/02/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|