The following data is part of a premarket notification filed by Harry J. Bosworth Co. with the FDA for Glass Ionomers-bio-glass Base/lining & Luting Cem..
| Device ID | K874500 |
| 510k Number | K874500 |
| Device Name: | GLASS IONOMERS-BIO-GLASS BASE/LINING & LUTING CEM. |
| Classification | Cement, Dental |
| Applicant | HARRY J. BOSWORTH CO. 7227 NORTH HAMLIN AVE. Skokie, IL 60076 |
| Contact | Jacqueline N Ruffo |
| Correspondent | Jacqueline N Ruffo HARRY J. BOSWORTH CO. 7227 NORTH HAMLIN AVE. Skokie, IL 60076 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-11-02 |
| Decision Date | 1988-02-18 |