Device Classification Name |
handpiece, air-powered, dental
|
510(k) Number |
K160410 |
Device Name |
WOlf High Speed Handpieces - Medium head, WOlf High Speed Handpieces - Small head |
Applicant |
Dental Savings Club |
31 Serge Garant |
Montreal,
CA
h3E 0A6
|
|
Applicant Contact |
Chadi Saade |
Correspondent |
QUALMED CORPORATION |
23 FORESTVIEW DR. |
CAMBRIDGE,
CA
N1T1V1
|
|
Correspondent Contact |
Gordon Wehner |
Regulation Number | 872.4200
|
Classification Product Code |
|
Date Received | 02/16/2016 |
Decision Date | 09/29/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|