Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Biomet 3i, LLC — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
113 daysmedian FDA review time
163 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251660 | T3 Pro Implants– ZimVie Packaging System | Biomet 3i, LLC | 2025-06-27 | 28 | 0 |
| K241753 | Immediate Molar Implants | Biomet 3i, LLC | 2024-10-23 | 127 | 0 |
| K241032 | BellaTek Bars | Biomet 3i, LLC | 2024-07-15 | 90 | 0 |
| K220978 | TSX Implants | Biomet 3i, LLC | 2022-09-14 | 163 | 0 |
| K213672 | T3 Pro Implants | Biomet 3i, LLC | 2022-03-28 | 126 | 0 |
| K212730 | BellaTek Encode Emergence Healing Abutments | Biomet 3i, LLC | 2021-12-21 | 113 | 0 |
| K192522 | TSV BellaTek Express and BellaTek Flex Abutments | Biomet 3i, LLC | 2019-12-09 | 87 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda