The following data is part of a premarket notification filed by Johnson & Johnson Professionals, Inc. with the FDA for Bondex* Glass Ionomer Cement.
| Device ID | K870211 |
| 510k Number | K870211 |
| Device Name: | BONDEX* GLASS IONOMER CEMENT |
| Classification | Cement, Dental |
| Applicant | JOHNSON & JOHNSON PROFESSIONALS, INC. 20 LAKE DR. CN 7060 East Windsor, NJ 08520 |
| Contact | Landsman, Mhs |
| Correspondent | Landsman, Mhs JOHNSON & JOHNSON PROFESSIONALS, INC. 20 LAKE DR. CN 7060 East Windsor, NJ 08520 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-01-20 |
| Decision Date | 1987-03-18 |