Device Classification Name |
Agent, Tooth Bonding, Resin
|
510(k) Number |
K941572 |
Device Name |
FLUORIDE-PSA PRIME/ADHESIVE |
Applicant |
DENTSPLY INTL. |
570 WEST COLLEGE AVE. |
P.O. BOX 872 |
YORK,
PA
17405
|
|
Applicant Contact |
P. JEFFREY LEHN |
Correspondent |
DENTSPLY INTL. |
570 WEST COLLEGE AVE. |
P.O. BOX 872 |
YORK,
PA
17405
|
|
Correspondent Contact |
P. JEFFREY LEHN |
Regulation Number | 872.3200
|
Classification Product Code |
|
Date Received | 03/31/1994 |
Decision Date | 06/10/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|