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 |