Device Classification Name |
Material, Tooth Shade, Resin
|
510(k) Number |
K122569 |
Device Name |
LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC LAVA ULTIMATE CAD/CAM RESTORATIVE FOR E4D LAVA ULTIMATE IMPLANT CROWN RESTOR |
Applicant |
3M COMPANY |
2510 CONWAY AVENUE |
ST. PAUL,
MN
55144
|
|
Applicant Contact |
GINGER CANTOR |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Correspondent Contact |
MARK JOB |
Regulation Number | 872.3690
|
Classification Product Code |
|
Date Received | 08/23/2012 |
Decision Date | 09/12/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|