Device Classification Name |
Agent, Tooth Bonding, Resin
|
510(k) Number |
K901913 |
Device Name |
SYNTAC (DENTIN BONDING AGENT) |
Applicant |
IVOCLAR NORTH AMERICA, INC. |
175 PINEVIEW DR. |
AMHERST,
NY
14228
|
|
Applicant Contact |
L SEVERANCE,DDS |
Correspondent |
IVOCLAR NORTH AMERICA, INC. |
175 PINEVIEW DR. |
AMHERST,
NY
14228
|
|
Correspondent Contact |
L SEVERANCE,DDS |
Regulation Number | 872.3200
|
Classification Product Code |
|
Date Received | 04/26/1990 |
Decision Date | 06/26/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|