The following data is part of a premarket notification filed by Ab Ardent with the FDA for Microhybrid 12.
Device ID | K022974 |
510k Number | K022974 |
Device Name: | MICROHYBRID 12 |
Classification | Material, Tooth Shade, Resin |
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 | EBF |
CFR Regulation Number | 872.3690 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-09-06 |
Decision Date | 2002-11-22 |