The following data is part of a premarket notification filed by Core-vent Corp. with the FDA for Sub-vent (tm) Implant/endosseous Blade Implant.
| Device ID | K861425 |
| 510k Number | K861425 |
| Device Name: | SUB-VENT (TM) IMPLANT/ENDOSSEOUS BLADE IMPLANT |
| Classification | Implant, Endosseous, Root-form |
| Applicant | CORE-VENT CORP. 15821 VENTURA BLVD. Encino, CA 91436 |
| Contact | Gerald A Niznick |
| Correspondent | Gerald A Niznick 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 | 1986-04-16 |
| Decision Date | 1986-11-05 |