Device Classification Name |
sealant, pit and fissure, and conditioner
|
510(k) Number |
K813015 |
Device Name |
HELIOSEAL |
Applicant |
VIVADENT (USA), INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
VIVADENT (USA), INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 872.3765
|
Classification Product Code |
|
Date Received | 10/27/1981 |
Decision Date | 12/02/1981 |
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
|
|
|