Device Classification Name |
Material, Tooth Shade, Resin
|
510(k) Number |
K121735 |
Device Name |
FIBER DISK AND BLOCK PERMANENT, TRINIA |
Applicant |
BIOLOREN SRL |
VIA ALESSANDRO VOLTA 59 |
SARONNO, VA,
IT
21047
|
|
Applicant Contact |
RATTI ANDREA |
Correspondent |
BIOLOREN SRL |
VIA ALESSANDRO VOLTA 59 |
SARONNO, VA,
IT
21047
|
|
Correspondent Contact |
RATTI ANDREA |
Regulation Number | 872.3690
|
Classification Product Code |
|
Date Received | 06/13/2012 |
Decision Date | 02/21/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|