The following data is part of a premarket notification filed by Friadent Gmbh with the FDA for Xive Tg Abutments.
Device ID | K032302 |
510k Number | K032302 |
Device Name: | XIVE TG ABUTMENTS |
Classification | Implant, Endosseous, Root-form |
Applicant | FRIADENT GMBH 21911 ERIE LN. Lake Forest, CA 92630 |
Contact | Carol Patterson |
Correspondent | Carol Patterson FRIADENT GMBH 21911 ERIE LN. Lake Forest, CA 92630 |
Product Code | DZE |
CFR Regulation Number | 872.3640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-07-25 |
Decision Date | 2003-10-02 |
Summary: | summary |