Device Classification Name |
Powder, Porcelain
|
510(k) Number |
K130991 |
Device Name |
NEXXZR(TM)T AND NEXXZR(TM)S |
Applicant |
SAGEMAX BIOCERAMICS, INC. |
34210 9th Ave S Suite 118 |
Federal Way,
WA
98003
|
|
Applicant Contact |
JOSE E CABRERA |
Correspondent |
SAGEMAX BIOCERAMICS, INC. |
34210 9th Ave S Suite 118 |
Federal Way,
WA
98003
|
|
Correspondent Contact |
JOSE E CABRERA |
Regulation Number | 872.6660
|
Classification Product Code |
|
Date Received | 04/10/2013 |
Decision Date | 02/10/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|