Device Classification Name |
resin, root canal filling
|
510(k) Number |
K063422 |
Device Name |
BIOAGGREGATE |
Applicant |
INNOVATIVE BIOCERAMIX INC. |
3650 WESBROOK MALL |
VANCOUVER, BC,
CA
V6S 2L2
|
|
Applicant Contact |
QUANZU YANG |
Correspondent |
INTERTEK TESTING SERVICES |
2307 EAST AURORA ROAD |
UNIT B7 |
TWINSBURG,
OH
44087
|
|
Correspondent Contact |
NEIL E DEVINE, JR. |
Regulation Number | 872.3820
|
Classification Product Code |
|
Date Received | 11/13/2006 |
Decision Date | 11/21/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|