Device Classification Name |
handpiece, air-powered, dental
|
510(k) Number |
K130560 |
Device Name |
MASTERTORQUE LUX 8900 L |
Applicant |
KALTENBACH & VOIGT GMBH |
BISMARCKRING 39 |
BIBERACH / RISS,
DE
88400
|
|
Applicant Contact |
STEFAN TRAMPLER |
Correspondent |
KALTENBACH & VOIGT GMBH |
BISMARCKRING 39 |
BIBERACH / RISS,
DE
88400
|
|
Correspondent Contact |
STEFAN TRAMPLER |
Regulation Number | 872.4200
|
Classification Product Code |
|
Date Received | 03/04/2013 |
Decision Date | 09/27/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|