The following data is part of a premarket notification filed by Core-vent Corp. with the FDA for Tcal Abutment.
| Device ID | K913782 |
| 510k Number | K913782 |
| Device Name: | TCAL ABUTMENT |
| Classification | Implant, Endosseous, Root-form |
| Applicant | CORE-VENT CORP. 1170 AVENIDA ACASO Camarillo, CA 93012 |
| Contact | Glen Neallly |
| Correspondent | Glen Neallly 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 | 1991-08-16 |
| Decision Date | 1991-10-30 |