The following data is part of a premarket notification filed by Biomet 3i, Inc. with the FDA for Osseotite 2 Dental Implants.
| Device ID | K111216 |
| 510k Number | K111216 |
| Device Name: | OSSEOTITE 2 DENTAL IMPLANTS |
| Classification | Implant, Endosseous, Root-form |
| Applicant | BIOMET 3I, INC. 4555 RIVERSIDE DR. Palm Beach Gardens, FL 33410 |
| Contact | Martha I Garay |
| Correspondent | Martha I Garay BIOMET 3I, INC. 4555 RIVERSIDE DR. Palm Beach Gardens, FL 33410 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-02 |
| Decision Date | 2011-11-18 |
| Summary: | summary |