| Device Classification Name |
Coating, Filling Material, Resin
|
| 510(k) Number |
K850073 |
| Device Name |
J & J LIGHT CURING DENTIN/ENAMEL BONDING AGENT |
| Applicant |
| Johnson & Johnson Professionals, Inc. |
| 20 Lake Dr. |
| Cn 7060 |
|
East Windsor,
NJ
08520
|
|
| Applicant Contact |
CAROL E LANDSMAN |
| Correspondent |
| Johnson & Johnson Professionals, Inc. |
| 20 Lake Dr. |
| Cn 7060 |
|
East Windsor,
NJ
08520
|
|
| Correspondent Contact |
CAROL E LANDSMAN |
| Regulation Number | 872.3310 |
| Classification Product Code |
|
| Date Received | 01/09/1985 |
| Decision Date | 02/08/1985 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Dental
|
| 510k Review Panel |
Dental
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|