The following data is part of a premarket notification filed by Advanced Healthcare Ltd. with the FDA for Ahl Generic Glass Ionomer Luting Cement.
| Device ID | K023981 |
| 510k Number | K023981 |
| Device Name: | AHL GENERIC GLASS IONOMER LUTING CEMENT |
| Classification | Cement, Dental |
| Applicant | ADVANCED HEALTHCARE LTD. 2907 BAY TO BAY BLVD. # 214 Tampa, FL 33629 |
| Contact | Bill Ettinger |
| Correspondent | Bill Ettinger ADVANCED HEALTHCARE LTD. 2907 BAY TO BAY BLVD. # 214 Tampa, FL 33629 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-12-02 |
| Decision Date | 2003-01-31 |