The following data is part of a premarket notification filed by Ab Ardent with the FDA for Futura Glass Ionomer Silver Reinforced.
Device ID | K991974 |
510k Number | K991974 |
Device Name: | FUTURA GLASS IONOMER SILVER REINFORCED |
Classification | Cement, Dental |
Applicant | AB ARDENT 54 RIVERVIEW AVE. Tonawanda, NY 14150 -5260 |
Contact | Clyde E Ingersoll |
Correspondent | Clyde E Ingersoll AB ARDENT 54 RIVERVIEW AVE. Tonawanda, NY 14150 -5260 |
Product Code | EMA |
CFR Regulation Number | 872.3275 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-06-11 |
Decision Date | 1999-09-17 |