Device Classification Name |
Barrier, Animal Source, Intraoral
|
510(k) Number |
K100695 |
FOIA Releasable 510(k) |
K100695
|
Device Name |
COLLADENTAL BARRIER |
Applicant |
COLLAMATRIX, INC |
26F, NO. 105, SECTION 2 DUNHUA |
SOUTH ROAD, DA-AN DISTRIC |
TAIPEI,
TW
106
|
|
Applicant Contact |
DENNIS J. N. SEAH |
Correspondent |
COLLAMATRIX, INC |
26F, NO. 105, SECTION 2 DUNHUA |
SOUTH ROAD, DA-AN DISTRIC |
TAIPEI,
TW
106
|
|
Correspondent Contact |
DENNIS J. N. SEAH |
Regulation Number | 872.3930
|
Classification Product Code |
|
Date Received | 03/11/2010 |
Decision Date | 01/03/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|