The following data is part of a premarket notification filed by Biomet 3i with the FDA for Cp4 Osseotite Certain Dental Implants.
| Device ID | K130949 |
| 510k Number | K130949 |
| Device Name: | CP4 OSSEOTITE CERTAIN DENTAL IMPLANTS |
| Classification | Implant, Endosseous, Root-form |
| Applicant | BIOMET 3I 4555 RIVERSIDE DR. Palm Bch Gdns, FL 33410 |
| Contact | Laura Hoshue |
| Correspondent | Laura Hoshue BIOMET 3I 4555 RIVERSIDE DR. Palm Bch Gdns, FL 33410 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-05 |
| Decision Date | 2013-07-30 |