Device Classification Name |
Resin, Denture, Relining, Repairing, Rebasing
|
510(k) Number |
K113788 |
Device Name |
DEFLEX ACRILATO |
Applicant |
NUXEN S.R.L. |
J B JUSTO 9741, PB |
BUENOS AIRES,
AR
C1408ALB
|
|
Applicant Contact |
HERNAN ILARI |
Correspondent |
NUXEN S.R.L. |
J B JUSTO 9741, PB |
BUENOS AIRES,
AR
C1408ALB
|
|
Correspondent Contact |
HERNAN ILARI |
Regulation Number | 872.3760
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/22/2011 |
Decision Date | 03/16/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|