Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Lifecore Biomedical, Inc. — Predicate Candidate Screening
34 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
84 daysmedian FDA review time
279 days90th percentile
34clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K073032 | PRIMACONNEX SD ESTHETIC CONTOUR ZI ABUTMENTS | Lifecore Biomedical, Inc. | 2007-11-16 | 21 | 0 |
| K072241 | PRIMACONNEX CAD/CAM ABUTMENT SYSTEM | Lifecore Biomedical, Inc. | 2007-11-09 | 88 | 0 |
| K072768 | RESTORE, STAGE-1, RENOVA PRIMASOLO AND PRIMACONNEX DENTAL IM | Lifecore Biomedical, Inc. | 2007-10-23 | 25 | 0 |
| K072572 | PRIMACONNEX RD AND WD ESTHETIC CONTOUR ZI ABUTMENTS | Lifecore Biomedical, Inc. | 2007-10-05 | 23 | 0 |
| K062876 | PRIMACONNEX CERAMIC ABUTMENTS | Lifecore Biomedical, Inc. | 2006-11-01 | 36 | 0 |
| K060530 | SD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING. MODEL 45301. | Lifecore Biomedical, Inc. | 2006-05-22 | 83 | 0 |
| K053643 | STAGE- 1 TEMPORARY/HEALING CAP, MODEL 42021-42026 | Lifecore Biomedical, Inc. | 2006-01-23 | 24 | 0 |
| K051614 | PRIMACONNEX INTERNAL CONNECTION IMPLANT SYSTEM, PRIMACONNEX | Lifecore Biomedical, Inc. | 2005-09-09 | 84 | 3 |
| K050506 | PRIMASOLO ONE-PIECE IMPLANTS & HEALING CAPS | Lifecore Biomedical, Inc. | 2005-04-15 | 46 | 0 |
| K041324 | CALMATRIX CALCIUM SULFATE BONE GRAFT BINDER | Lifecore Biomedical, Inc. | 2004-07-19 | 62 | 0 |
| K032774 | RENOVA INTERNAL HEX IMPLANT SYSTEM | Lifecore Biomedical, Inc. | 2003-11-26 | 79 | 0 |
| K032495 | THE LIFECORE STAGE-1 ANGLED ABUTMENT SYSTEM | Lifecore Biomedical, Inc. | 2003-09-17 | 35 | 0 |
| K002037 | LIFECORE BIOMEDICAL DENTAL IMPLANT SYSTEMS | Lifecore Biomedical, Inc. | 2001-05-16 | 315 | 0 |
| K003226 | THE LIFECORE STAGE-1 SINGLE STAGE RBM DENTAL IMPLANT SYSTEM | Lifecore Biomedical, Inc. | 2001-01-12 | 88 | 0 |
| K993894 | LIFECORE SINGLE TOOTH ABUTMENT SYSTEM | Lifecore Biomedical, Inc. | 2000-03-08 | 113 | 0 |
| K994205 | MODIFICATION OF REGULAR DIAMETER SINGLE STAGE (RDS) TPS DENT | Lifecore Biomedical, Inc. | 2000-02-29 | 90 | 0 |
| K991114 | REGULAR DIAMETER SINGLE STAGE (RDS) TPS DENTAL IMPLANT SYSTE | Lifecore Biomedical, Inc. | 1999-07-14 | 104 | 0 |
| K970776 | LIFECORE O-RING ABUTMENT;LIFECORE DALLA BONA ABUTMENT | Lifecore Biomedical, Inc. | 1997-05-27 | 84 | 0 |
| K965135 | LIFECORE CONICAL ABUTMENT | Lifecore Biomedical, Inc. | 1997-02-25 | 64 | 0 |
| K961511 | HAPSET HYDROXYLAPATITE BONE GRAFT PLASTER | Lifecore Biomedical, Inc. | 1996-06-28 | 70 | 0 |
| K960288 | HA & TPS RESTORE SELF TAPPING DENTAL IMPLANT SYSTEM | Lifecore Biomedical, Inc. | 1996-03-28 | 66 | 0 |
| K954512 | RESTORE SELF TAPPING DENTAL IMPLANT SYSTEM | Lifecore Biomedical, Inc. | 1996-02-23 | 148 | 0 |
| K955096 | CAPSET CALCIUM SULFATE BONE GRAFT PLASTER | Lifecore Biomedical, Inc. | 1996-01-23 | 77 | 0 |
| K954865 | RESTORE HA DENTAL IMPLANT SYSTEM | Lifecore Biomedical, Inc. | 1996-01-11 | 80 | 0 |
| K954819 | RESTORE TPS DENTAL IMPLANT SYSTEM SUSTAIN TPS DENTAL IMPLANT | Lifecore Biomedical, Inc. | 1996-01-11 | 83 | 0 |
| K950624 | HA- AND TPS- RESTORE SELF TAPPING DENTAL IMPLANT SYSTEM | Lifecore Biomedical, Inc. | 1995-08-30 | 201 | 0 |
| K943186 | CAPSET CALCIUM SULFATE BONE GRAFT PLASTER | Lifecore Biomedical, Inc. | 1995-04-10 | 279 | 0 |
| K951111 | RESTORE SELF TAPPING DENTAL IMPLANT SYSTEM (3.4MM) | Lifecore Biomedical, Inc. | 1995-03-31 | 21 | 0 |
| K944069 | RESTORE TPS LHEX CYLINDER ENDOSSEOUS IMPLANT SYSTEM | Lifecore Biomedical, Inc. | 1995-02-28 | 194 | 0 |
| K944068 | RESTORE SELF TAPPING DENTAL IMPLANT SYST (5, 5.5,6MM) | Lifecore Biomedical, Inc. | 1995-02-02 | 171 | 0 |
| K941554 | SUSTAIN HEX HA-COATED CYLINDER ENDOSSEOUS IMPLANT SYSTEM | Lifecore Biomedical, Inc. | 1994-07-22 | 114 | 0 |
| K931468 | RESTORE HEX CYLINDER ENDOSSEOUS SYSTEM | Lifecore Biomedical, Inc. | 1994-07-12 | 475 | 0 |
| K914137 | HA-BIONTEGRATED DENTAL IMPLANT SYSTEMS | Lifecore Biomedical, Inc. | 1994-02-03 | 871 | 0 |
| K910432 | HAPSET HYDROXYLAPATITE BONE GRAFT PLASTER | Lifecore Biomedical, Inc. | 1991-05-01 | 90 | 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