Device Classification Name |
Scaler, Ultrasonic
|
510(k) Number |
K062731 |
Device Name |
ULTRASONIC SCALER, VARIOS 560 |
Applicant |
NAKANISHI, INC. |
700 SHIMOHINATA |
KANUMA-SHI, TOCHIGI-KEN,
JP
322-8666
|
|
Applicant Contact |
NORIMASA KANEKO |
Correspondent |
NAKANISHI, INC. |
700 SHIMOHINATA |
KANUMA-SHI, TOCHIGI-KEN,
JP
322-8666
|
|
Correspondent Contact |
NORIMASA KANEKO |
Regulation Number | 872.4850
|
Classification Product Code |
|
Date Received | 09/13/2006 |
Decision Date | 05/01/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|