Device Classification Name |
unit, operative dental, accessories
|
510(k) Number |
K072273 |
Device Name |
BELMONT QUOLIS 5000 SERIES DENTAL UNIT |
Applicant |
TAKARA BELMONT USA, INC. |
1129 BLOOMFIELD AVENUE |
WEST CALDWELL,
NJ
07006
|
|
Applicant Contact |
ROBERT SCHIFF |
Correspondent |
TAKARA BELMONT USA, INC. |
1129 BLOOMFIELD AVENUE |
WEST CALDWELL,
NJ
07006
|
|
Correspondent Contact |
ROBERT SCHIFF |
Regulation Number | 872.6640
|
Classification Product Code |
|
Date Received | 08/15/2007 |
Decision Date | 12/20/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|