The following data is part of a premarket notification filed by Wallace A. Erickson & Co. with the FDA for Alpha-dent Temporary Crown And Bridge Material.
Device ID | K960122 |
510k Number | K960122 |
Device Name: | ALPHA-DENT TEMPORARY CROWN AND BRIDGE MATERIAL |
Classification | Crown And Bridge, Temporary, Resin |
Applicant | WALLACE A. ERICKSON & CO. 1920 NORTH CLYBOURN AVE. Chicago, IL 60614 |
Contact | Abner T De La Cruz |
Correspondent | Abner T De La Cruz WALLACE A. ERICKSON & CO. 1920 NORTH CLYBOURN AVE. Chicago, IL 60614 |
Product Code | EBG |
CFR Regulation Number | 872.3770 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-01-16 |
Decision Date | 1996-02-21 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
D77819312570 | K960122 | 000 |
D73511300060020 | K960122 | 000 |
D73511300070020 | K960122 | 000 |
D73511300080020 | K960122 | 000 |
D73511300090020 | K960122 | 000 |
D77819312410 | K960122 | 000 |
D77819312430 | K960122 | 000 |
D77819312450 | K960122 | 000 |
D77819312500 | K960122 | 000 |
D73511300050020 | K960122 | 000 |