Device Classification Name |
scaler, ultrasonic
|
510(k) Number |
K031421 |
Device Name |
ULTRASONIC SCALER, MODELS VARIOS 350 LUX, VARIOS 350 (NO LIGHT), VARIOS 550, VARIOS 150 LUX, VARIOS 150 (NO LIGHT) |
Applicant |
NAKANISHI, INC. |
700B COOPER COURT |
SCHAUMBURG,
IL
60173
|
|
Applicant Contact |
MASAYUKI ONOGUCHI |
Correspondent |
NAKANISHI, INC. |
700B COOPER COURT |
SCHAUMBURG,
IL
60173
|
|
Correspondent Contact |
MASAYUKI ONOGUCHI |
Regulation Number | 872.4850
|
Classification Product Code |
|
Date Received | 05/05/2003 |
Decision Date | 03/26/2004 |
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
|
|
|