The following data is part of a premarket notification filed by Interpore Intl. with the FDA for Interpore Imz Single Tooth Attachment System.
Device ID | K900793 |
510k Number | K900793 |
Device Name: | INTERPORE IMZ SINGLE TOOTH ATTACHMENT SYSTEM |
Classification | Implant, Endosseous, Root-form |
Applicant | INTERPORE INTL. 18008 SKYPARK CIRCLE Irvine, CA 92714 |
Contact | Dean A Knight |
Correspondent | Dean A Knight INTERPORE INTL. 18008 SKYPARK CIRCLE Irvine, CA 92714 |
Product Code | DZE |
CFR Regulation Number | 872.3640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-02-20 |
Decision Date | 1990-07-27 |