Device Classification Name |
Handpiece, Contra- And Right-Angle Attachment, Dental
|
510(k) Number |
K121901 |
Device Name |
TI-MAX Z45 |
Applicant |
NAKANISHI, INC. |
4-4-17 HONGO |
BUNKYO-KU,
JP
113-0033
|
|
Applicant Contact |
FUMIAKI KANAI |
Correspondent |
NAKANISHI, INC. |
4-4-17 HONGO |
BUNKYO-KU,
JP
113-0033
|
|
Correspondent Contact |
FUMIAKI KANAI |
Regulation Number | 872.4200
|
Classification Product Code |
|
Date Received | 06/29/2012 |
Decision Date | 02/28/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|