The following data is part of a premarket notification filed by Implant Direct Sybron Manufacturing Llc with the FDA for Interactive/ Swishplus2 Implant System.
| Device ID | K130572 |
| 510k Number | K130572 |
| Device Name: | INTERACTIVE/ SWISHPLUS2 IMPLANT SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | IMPLANT DIRECT SYBRON MANUFACTURING LLC 27030 MALIBU HILLS RD Calabasas, CA 91301 |
| Contact | Ines Aravena |
| Correspondent | Ines Aravena IMPLANT DIRECT SYBRON MANUFACTURING LLC 27030 MALIBU HILLS RD Calabasas, 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 | 2013-03-04 |
| Decision Date | 2013-12-24 |
| Summary: | summary |