Device Classification Name |
instrument, diamond, dental
|
510(k) Number |
K120037 |
Device Name |
BLUWHITE DIAMOND DENTAL BURS MODIFIED |
Applicant |
BEAVERS DENTAL, DIV. SYBRON CANADA, LTD. |
1717 WEST COLLINS AVENUE |
ORANGE,
CA
92867
|
|
Applicant Contact |
Wendy Garman |
Correspondent |
BEAVERS DENTAL, DIV. SYBRON CANADA, LTD. |
1717 WEST COLLINS AVENUE |
ORANGE,
CA
92867
|
|
Correspondent Contact |
Wendy Garman |
Regulation Number | 872.4535
|
Classification Product Code |
|
Date Received | 01/05/2012 |
Decision Date | 04/20/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|