The following data is part of a premarket notification filed by Core-vent Corp. with the FDA for Swissplus Implant System, Model Spwb 8,10,12,14/oph20/smpr, Spb 8,10,12,14/op3.5d/opar,opb 8,10,12,14/op2.3d/op2.8d,.
| Device ID | K002188 |
| 510k Number | K002188 |
| Device Name: | SWISSPLUS IMPLANT SYSTEM, MODEL SPWB 8,10,12,14/OPH20/SMPR, SPB 8,10,12,14/OP3.5D/OPAR,OPB 8,10,12,14/OP2.3D/OP2.8D, |
| Classification | Implant, Endosseous, Root-form |
| Applicant | CORE-VENT CORP. 4630 SOUTH ARVILLE STE D Las Vegas, NV 89103 |
| Contact | Will Fisher |
| Correspondent | Will Fisher CORE-VENT CORP. 4630 SOUTH ARVILLE STE D Las Vegas, NV 89103 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-07-20 |
| Decision Date | 2000-10-30 |