Biomet 3i, Inc.: FDA filings under this applicant name
FDA lists 25 510(k) clearances under 2 spellings of the applicant name “Biomet 3i, Inc.” (first 2007, latest 2019), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 134 days. Since 2017 the median was 231 days, against 191 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 148 |
| 2013 | 3 | 134 |
| 2014 | 1 | 103 |
| 2015 | 1 | 259 |
| 2016 | 0 | — |
| 2017 | 2 | 154 |
| 2018 | 0 | — |
| 2019 | 1 | 231 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Biomet 3i, Inc. took a median 231 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 191 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NHA | Abutment, Implant, Dental, Endosseous | 16 | 16 |
| DZE | Implant, Endosseous, Root-Form | 7 | 7 |
| LYC | Bone Grafting Material, Synthetic | 1 | 1 |
| NUN | Bone Grafting Material, Human Source | 1 | 1 |
Review panels
- Dental (25)
Most recent Biomet 3i, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K183138 | Certain BellaTek Express and BellaTek Flex Abutments | NHA | 2019-07-02 | 231 |
| K173374 | TSV BellaTek Encode Healing Abutments | NHA | 2017-12-13 | 47 |
| K170013 | Eztetic BellaTek Encode Healing Abutments | NHA | 2017-09-21 | 261 |
| K150571 | 3i T3 Short Implants | DZE | 2015-11-20 | 259 |
| K133049 | 3I T3(R) EXTERNAL HEX DENTAL IMPLANTS | DZE | 2014-01-08 | 103 |
| K130949 | CP4 OSSEOTITE CERTAIN DENTAL IMPLANTS | DZE | 2013-07-30 | 116 |
| K130310 | CERTAIN BELLATEK PROVISIONAL ABUTMENTS | NHA | 2013-06-21 | 134 |
| K122300 | T3 DENTAL IMPLANT | DZE | 2013-01-30 | 183 |
| K120776 | ABUTMENT FOR COMPETITIVE IMPLANT NOBEL ACTIVE CONNECTION | NHA | 2012-09-11 | 181 |
| K112730 | ABUTMENT FOR COMPETITIVE IMPLANT STRAUMANN BONE LEVEL CONNECTION | NHA | 2012-01-13 | 115 |
15 earlier clearances. See the full list in Caduvo.
Recalls
10 product recalls in 9 recall events; 0 initiated in the last five years. Most recent: 2008-05-09.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
FDA spellings included
FDA records this applicant under 2 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- Biomet 3i, Inc. (13)
- Biomet 3i (12)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Biomet, Inc. (445 510(k)s)
- Biomet Manufacturing Corp (126 510(k)s)
- Biomet Orthopedics, Inc. (40 510(k)s)
- Biomet Microfixation (30 510(k)s)
- Biomet Spine (19 510(k)s)
- Biomet Spine (Aka Ebi, LLC) (13 510(k)s)
- Biomet Sports Medicine (13 510(k)s)
- Biomet 3i, LLC (7 510(k)s)
- Biomet Trauma (7 510(k)s)
- Biomet Spine, LLC (4 510(k)s)
- Biomet Micofixation (3 510(k)s)
- Biomet Trauma (Aka Ebi, Lp) (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Biomet 3i, Inc.?
FDA lists 25 510(k) clearances under 2 spellings of the applicant name “Biomet 3i, Inc.” (first 2007, latest 2019), across 4 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Biomet 3i, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Biomet 3i, Inc. is 134 days. Since 2017: 231 days, versus 191 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Biomet 3i, Inc.?
The most frequent FDA product codes under this applicant name are NHA (Abutment, Implant, Dental, Endosseous, 16); DZE (Implant, Endosseous, Root-Form, 7); LYC (Bone Grafting Material, Synthetic, 1).
Next steps
- See all 25 Biomet 3i, Inc. clearances with predicates and recalls
- Run predicate analysis for product code NHA, Biomet 3i, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.