Device Classification Name |
Handpiece, Air-Powered, Root Canal Irrigation
|
510(k) Number |
K100606 |
Device Name |
VATEA ENDONTIC IRRIGATION SYSTEM |
Applicant |
REDENT NOVA LTD |
COLUMBIA SQUARE |
555 13TH STREET, NW |
WASHINGTON,
DC
20004
|
|
Applicant Contact |
JONATHAN S KAHAN |
Correspondent |
REDENT NOVA LTD |
COLUMBIA SQUARE |
555 13TH STREET, NW |
WASHINGTON,
DC
20004
|
|
Correspondent Contact |
JONATHAN S KAHAN |
Regulation Number | 872.4200
|
Classification Product Code |
|
Date Received | 03/03/2010 |
Decision Date | 05/28/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|