The following data is part of a premarket notification filed by Core-vent Corp. with the FDA for Pre-angled Abutments.
Device ID | K912059 |
510k Number | K912059 |
Device Name: | PRE-ANGLED ABUTMENTS |
Classification | Implant, Endosseous, Root-form |
Applicant | CORE-VENT CORP. 1170 AVENIDA ACASO Camarillo, CA 93012 |
Contact | Glen Neally |
Correspondent | Glen Neally CORE-VENT CORP. 1170 AVENIDA ACASO Camarillo, CA 93012 |
Product Code | DZE |
CFR Regulation Number | 872.3640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-05-09 |
Decision Date | 1992-02-11 |