The following data is part of a premarket notification filed by Ho Dental Co., Inc. with the FDA for Hd-4 Crown & Bridge Alloy.
Device ID | K905034 |
510k Number | K905034 |
Device Name: | HD-4 CROWN & BRIDGE ALLOY |
Classification | Alloy, Metal, Base |
Applicant | HO DENTAL CO., INC. P.O. BOX 143 2723 HAWTHORN LN. Wilmette, IL 60091 |
Contact | David Holzmann |
Correspondent | David Holzmann HO DENTAL CO., INC. P.O. BOX 143 2723 HAWTHORN LN. Wilmette, IL 60091 |
Product Code | EJH |
CFR Regulation Number | 872.3710 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-11-07 |
Decision Date | 1991-09-05 |