Device Classification Name |
toothbrush, manual
|
510(k) Number |
K102871 |
Device Name |
SILVER CARE ANITBACTERIAL TOOTHBRUSH |
Applicant |
PIAVE SPAZZOLIFICIO S.P.A. |
212 W 91ST ST |
APT 812 |
NEW YORK,
NY
10024
|
|
Applicant Contact |
KEILA LACOURT |
Correspondent |
PIAVE SPAZZOLIFICIO S.P.A. |
212 W 91ST ST |
APT 812 |
NEW YORK,
NY
10024
|
|
Correspondent Contact |
KEILA LACOURT |
Regulation Number | 872.6855
|
Classification Product Code |
|
Date Received | 09/30/2010 |
Decision Date | 10/03/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|