The following data is part of a premarket notification filed by Aalba Dent, Inc. with the FDA for Verasoft Casting Alloy.
Device ID | K925579 |
510k Number | K925579 |
Device Name: | VERASOFT CASTING ALLOY |
Classification | Alloy, Metal, Base |
Applicant | AALBA DENT, INC. 1819 SO. MAY STREET, 2F Chicago, IL 60608 |
Contact | Robert W Bauer |
Correspondent | Robert W Bauer AALBA DENT, INC. 1819 SO. MAY STREET, 2F Chicago, IL 60608 |
Product Code | EJH |
CFR Regulation Number | 872.3710 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-11-04 |
Decision Date | 1993-03-16 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
90852187007104 | K925579 | 000 |