The following data is part of a premarket notification filed by Biomet 3i Llc with the FDA for T3 Pro Implants.
| Device ID | K213672 |
| 510k Number | K213672 |
| Device Name: | T3 Pro Implants |
| Classification | Implant, Endosseous, Root-form |
| Applicant | Biomet 3i LLC 4555 Riverside Drive Palm Beach Gardens, FL 33410 |
| Contact | Krupal Patel |
| Correspondent | Krupal Patel Biomet 3i LLC 4555 Riverside Drive Palm Beach Gardens, 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 | 2021-11-22 |
| Decision Date | 2022-03-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00844868047056 | K213672 | 000 |
| 00844868046844 | K213672 | 000 |
| 00844868046837 | K213672 | 000 |
| 00844868046820 | K213672 | 000 |
| 00844868046813 | K213672 | 000 |
| 00844868046806 | K213672 | 000 |
| 00844868046790 | K213672 | 000 |
| 00844868046783 | K213672 | 000 |
| 00844868046776 | K213672 | 000 |
| 00844868046769 | K213672 | 000 |
| 00844868046752 | K213672 | 000 |
| 00844868046745 | K213672 | 000 |
| 00844868046738 | K213672 | 000 |
| 00844868046721 | K213672 | 000 |
| 00844868046851 | K213672 | 000 |
| 00844868046912 | K213672 | 000 |
| 00844868047049 | K213672 | 000 |
| 00844868047032 | K213672 | 000 |
| 00844868047025 | K213672 | 000 |
| 00844868047018 | K213672 | 000 |
| 00844868047001 | K213672 | 000 |
| 00844868046998 | K213672 | 000 |
| 00844868046981 | K213672 | 000 |
| 00844868046974 | K213672 | 000 |
| 00844868046967 | K213672 | 000 |
| 00844868046950 | K213672 | 000 |
| 00844868046943 | K213672 | 000 |
| 00844868046936 | K213672 | 000 |
| 00844868046929 | K213672 | 000 |
| 00844868046714 | K213672 | 000 |