The following data is part of a premarket notification filed by Advanced Healthcare Ltd. with the FDA for Fixobridge 3-cement.
| Device ID | K024287 |
| 510k Number | K024287 |
| Device Name: | FIXOBRIDGE 3-CEMENT |
| Classification | Cement, Dental |
| Applicant | ADVANCED HEALTHCARE LTD. 271 WALTROUP RD. P.O. BOX 457 Hot Springs, NC 28743 |
| Contact | Dagmar Maeser |
| Correspondent | Dagmar Maeser ADVANCED HEALTHCARE LTD. 271 WALTROUP RD. P.O. BOX 457 Hot Springs, NC 28743 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-12-23 |
| Decision Date | 2003-03-21 |