The following data is part of a premarket notification filed by Biomet 3i with the FDA for T3 Dental Implant.
| Device ID | K122300 |
| 510k Number | K122300 |
| Device Name: | T3 DENTAL IMPLANT |
| Classification | Implant, Endosseous, Root-form |
| Applicant | BIOMET 3I 4555 RIVERSIDE DR. Palm Bch Gdns, FL 33410 |
| Contact | Tamara West |
| Correspondent | Tamara West 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 | 2012-07-31 |
| Decision Date | 2013-01-30 |
| Summary: | summary |