Device Classification Name |
Material, Tooth Shade, Resin
|
510(k) Number |
K874189 |
Device Name |
DUAL-CURE RADIOPAQUE |
Applicant |
PENTRON CORP. |
53 NORTH PLAINS INDUSTRIAL RD. |
P.O. BOX 724 |
WALLINGFORD,
CT
06492
|
|
Applicant Contact |
MARTIN L SCHULMAN |
Correspondent |
PENTRON CORP. |
53 NORTH PLAINS INDUSTRIAL RD. |
P.O. BOX 724 |
WALLINGFORD,
CT
06492
|
|
Correspondent Contact |
MARTIN L SCHULMAN |
Regulation Number | 872.3690
|
Classification Product Code |
|
Date Received | 10/14/1987 |
Decision Date | 02/11/1988 |
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
|
|
|