The following data is part of a premarket notification filed by Advanced Healthcare Ltd. with the FDA for Ahl Generic Glass Ionomer Aesthetic Restorative.
| Device ID | K020376 |
| 510k Number | K020376 |
| Device Name: | AHL GENERIC GLASS IONOMER AESTHETIC RESTORATIVE |
| Classification | Cement, Dental |
| Applicant | ADVANCED HEALTHCARE LTD. 13161 TELFAIR AVE. Sylmar, CA 91342 |
| Contact | Perry Kashfian |
| Correspondent | Perry Kashfian ADVANCED HEALTHCARE LTD. 13161 TELFAIR AVE. Sylmar, CA 91342 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-02-04 |
| Decision Date | 2002-04-09 |