Lifecore Biomedical, Inc.: FDA filings under this applicant name
FDA lists 34 510(k) clearances under the applicant name “Lifecore Biomedical, Inc.” (first 1991, latest 2007), plus 1 PMA decision, across 6 product codes in 3 review panels. Median 510(k) review time under this name: 84 days. 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 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DZE | Implant, Endosseous, Root-Form | 23 | 23 |
| NHA | Abutment, Implant, Dental, Endosseous | 5 | 5 |
| LYC | Bone Grafting Material, Synthetic | 4 | 4 |
| ELL | Teeth, Porcelain | 1 | 1 |
| LZK | Implant, Malar | 1 | 1 |
| MCN | Barrier, Absorbable, Adhesion | 1 | 0 |
Review panels
Most recent Lifecore Biomedical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K073032 | PRIMACONNEX SD ESTHETIC CONTOUR ZI ABUTMENTS | NHA | 2007-11-16 | 21 |
| K072241 | PRIMACONNEX CAD/CAM ABUTMENT SYSTEM | NHA | 2007-11-09 | 88 |
| K072768 | RESTORE, STAGE-1, RENOVA PRIMASOLO AND PRIMACONNEX DENTAL IMPLANTS | DZE | 2007-10-23 | 25 |
| K072572 | PRIMACONNEX RD AND WD ESTHETIC CONTOUR ZI ABUTMENTS | NHA | 2007-10-05 | 23 |
| K062876 | PRIMACONNEX CERAMIC ABUTMENTS | NHA | 2006-11-01 | 36 |
| K060530 | SD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING. MODEL 45301. RD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING, MODEL 45302. | ELL | 2006-05-22 | 83 |
| K053643 | STAGE- 1 TEMPORARY/HEALING CAP, MODEL 42021-42026 | NHA | 2006-01-23 | 24 |
| K051614 | PRIMACONNEX INTERNAL CONNECTION IMPLANT SYSTEM, PRIMACONNEX INTERNAL CONNECTION PROSTHETICS | DZE | 2005-09-09 | 84 |
| K050506 | PRIMASOLO ONE-PIECE IMPLANTS & HEALING CAPS | DZE | 2005-04-15 | 46 |
| K041324 | CALMATRIX CALCIUM SULFATE BONE GRAFT BINDER | LYC | 2004-07-19 | 62 |
24 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P990015 | PMA | INTERGEL ADHESION PREVENTION SOLUTION | 2001-11-16 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2004-06-03.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Lifecore Biomedical, Inc.?
FDA lists 34 510(k) clearances under the applicant name “Lifecore Biomedical, Inc.” (first 1991, latest 2007), plus 1 PMA decision, across 6 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Lifecore Biomedical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Lifecore Biomedical, Inc. is 84 days.
Which FDA product codes appear under Lifecore Biomedical, Inc.?
The most frequent FDA product codes under this applicant name are DZE (Implant, Endosseous, Root-Form, 23); NHA (Abutment, Implant, Dental, Endosseous, 5); LYC (Bone Grafting Material, Synthetic, 4).
Next steps
- See all 34 Lifecore Biomedical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DZE, Lifecore Biomedical, 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.