The following data is part of a premarket notification filed by Core-vent Bio-engineering, Inc. with the FDA for Paragon Implant System.
| Device ID | K953101 |
| 510k Number | K953101 |
| Device Name: | PARAGON IMPLANT SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | CORE-VENT BIO-ENGINEERING, INC. 27030 MALIBU HILLS RD. Calabasas Hills, CA 91301 |
| Contact | Rosemarie Masteller |
| Correspondent | Rosemarie Masteller CORE-VENT BIO-ENGINEERING, INC. 27030 MALIBU HILLS RD. Calabasas Hills, CA 91301 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-03 |
| Decision Date | 1995-12-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024017054 | K953101 | 000 |
| 00889024015173 | K953101 | 000 |
| 00889024015142 | K953101 | 000 |
| 00889024013766 | K953101 | 000 |
| 00889024016583 | K953101 | 000 |
| 00889024016576 | K953101 | 000 |
| 00889024015647 | K953101 | 000 |
| 00889024013704 | K953101 | 000 |