Device Classification Name |
powder, porcelain
|
510(k) Number |
K193434 |
Device Name |
VITA LUMEX AC |
Applicant |
VITA Zahnfabrik GmbH H Rauter & Co |
Spitelgasse 3 |
Bad Sackingen,
DE
D-79713
|
|
Applicant Contact |
Bernd Walker |
Correspondent |
VITA North America |
22705 Savi Ranch Parkway, Suite 100 |
Yorba Linda,
CA
92887
|
|
Correspondent Contact |
Lindsay Tilton |
Regulation Number | 872.6660
|
Classification Product Code |
|
Date Received | 12/11/2019 |
Decision Date | 07/21/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|