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 |