Device Classification Name |
material, tooth shade, resin
|
510(k) Number |
K051931 |
Device Name |
AXCEL |
Applicant |
TRI DENTAL INNOVATORS |
13902 WEST ST., UNIT C |
GARDEN GROVE,
CA
92843
|
|
Applicant Contact |
LINDA NGUYEN |
Correspondent |
TRI DENTAL INNOVATORS |
13902 WEST ST., UNIT C |
GARDEN GROVE,
CA
92843
|
|
Correspondent Contact |
LINDA NGUYEN |
Regulation Number | 872.3690
|
Classification Product Code |
|
Date Received | 07/13/2005 |
Decision Date | 02/17/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|