Device Classification Name |
Handpiece, Air-Powered, Dental
|
510(k) Number |
K113655 |
Device Name |
TI-MAX X TURBINE |
Applicant |
NAKANISHI, INC. |
1201 RICHARDSON DRIVE |
SUITE 280 |
RICHARDSON,
TX
75080
|
|
Applicant Contact |
DIANE RUTHERFORD |
Correspondent |
NAKANISHI, INC. |
1201 RICHARDSON DRIVE |
SUITE 280 |
RICHARDSON,
TX
75080
|
|
Correspondent Contact |
DIANE RUTHERFORD |
Regulation Number | 872.4200
|
Classification Product Code |
|
Date Received | 12/12/2011 |
Decision Date | 03/05/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|