The following data is part of a premarket notification filed by Harry J. Bosworth Co. with the FDA for Bosworth Aegis Liner & Restorative Material W/acp.
| Device ID | K103585 |
| 510k Number | K103585 |
| Device Name: | BOSWORTH AEGIS LINER & RESTORATIVE MATERIAL W/ACP |
| Classification | Cement, Dental |
| Applicant | HARRY J. BOSWORTH CO. 7227 NORTH HAMLIN AVE. Skokie, IL 60076 |
| Contact | Gary Chuven |
| Correspondent | Gary Chuven 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 | 2010-12-07 |
| Decision Date | 2011-03-04 |