Device Classification Name |
sealant, pit and fissure, and conditioner
|
510(k) Number |
K932078 |
Device Name |
HELIOSEAL F |
Applicant |
IVOCLAR NORTH AMERICA, INC. |
175 PINEVIEW DR. |
AMHERST,
NY
14228
|
|
Applicant Contact |
LLOYD ZIEMENDORF |
Correspondent |
IVOCLAR NORTH AMERICA, INC. |
175 PINEVIEW DR. |
AMHERST,
NY
14228
|
|
Correspondent Contact |
LLOYD ZIEMENDORF |
Regulation Number | 872.3765
|
Classification Product Code |
|
Date Received | 04/29/1993 |
Decision Date | 09/15/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|