The following data is part of a premarket notification filed by Aalba Dent, Inc. with the FDA for Npg 2 Base Metal Alloy.
Device ID | K892419 |
510k Number | K892419 |
Device Name: | NPG 2 BASE METAL ALLOY |
Classification | Bracket, Metal, Orthodontic |
Applicant | AALBA DENT, INC. 111 N. WABASH Chicago, IL 60602 |
Contact | Bauer, Phd |
Correspondent | Bauer, Phd AALBA DENT, INC. 111 N. WABASH Chicago, IL 60602 |
Product Code | EJF |
CFR Regulation Number | 872.5410 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-04-10 |
Decision Date | 1989-06-16 |