The following data is part of a premarket notification filed by Aalba Dent, Inc. with the FDA for Verabond 2.
Device ID | K982094 |
510k Number | K982094 |
Device Name: | VERABOND 2 |
Classification | Alloy, Metal, Base |
Applicant | AALBA DENT, INC. 400 WATT DR. Cordelia, CA 94534 |
Contact | Vincent Benetti |
Correspondent | Vincent Benetti AALBA DENT, INC. 400 WATT DR. Cordelia, CA 94534 |
Product Code | EJH |
CFR Regulation Number | 872.3710 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-06-15 |
Decision Date | 1998-07-22 |