The following data is part of a premarket notification filed by Implant Direct Sybron Manufacturing Llc with the FDA for Legacy3 6mm Length Implants.
| Device ID | K131097 |
| 510k Number | K131097 |
| Device Name: | LEGACY3 6MM LENGTH IMPLANTS |
| 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 | 2013-04-18 |
| Decision Date | 2013-08-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10841307107675 | K131097 | 000 |
| 10841307107668 | K131097 | 000 |
| 10841307107651 | K131097 | 000 |
| 10841307107644 | K131097 | 000 |
| 10841307107637 | K131097 | 000 |