The following data is part of a premarket notification filed by Core-vent Corp. with the FDA for Swede-vent Endosseous Ha Coated Dental Implants.
| Device ID | K900634 |
| 510k Number | K900634 |
| Device Name: | SWEDE-VENT ENDOSSEOUS HA COATED DENTAL IMPLANTS |
| Classification | Implant, Endosseous, Root-form |
| Applicant | CORE-VENT CORP. 15821 VENTURA BLVD. Encino, CA 91436 |
| Contact | Patrick, Dds |
| Correspondent | Patrick, Dds CORE-VENT CORP. 15821 VENTURA BLVD. Encino, CA 91436 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-02-09 |
| Decision Date | 1990-11-09 |