Company ยท US
Lifecore Biomedical, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1991 to 2007. Name variants (Inc, Corp, punctuation) are merged.
34510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 16, 2007 | K073032 | PRIMACONNEX SD ESTHETIC CONTOUR ZI ABUTMENTS Lifecore Biomedical, Inc. | NHA |
| Nov 9, 2007 | K072241 | PRIMACONNEX CAD/CAM ABUTMENT SYSTEM Lifecore Biomedical, Inc. | NHA |
| Oct 23, 2007 | K072768 | RESTORE, STAGE-1, RENOVA PRIMASOLO AND PRIMACONNEX DENTAL IMPLANTS Lifecore Biomedical, Inc. | DZE |
| Oct 5, 2007 | K072572 | PRIMACONNEX RD AND WD ESTHETIC CONTOUR ZI ABUTMENTS Lifecore Biomedical, Inc. | NHA |
| Nov 1, 2006 | K062876 | PRIMACONNEX CERAMIC ABUTMENTS Lifecore Biomedical, Inc. | NHA |
| May 22, 2006 | K060530 | SD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING. MODEL 45301. RD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING, MODEL 45302. Lifecore Biomedical, Inc. | ELL |
| Jan 23, 2006 | K053643 | STAGE- 1 TEMPORARY/HEALING CAP, MODEL 42021-42026 Lifecore Biomedical, Inc. | NHA |
| Sep 9, 2005 | K051614 | PRIMACONNEX INTERNAL CONNECTION IMPLANT SYSTEM, PRIMACONNEX INTERNAL CONNECTION PROSTHETICS Lifecore Biomedical, Inc. | DZE |
| Apr 15, 2005 | K050506 | PRIMASOLO ONE-PIECE IMPLANTS & HEALING CAPS Lifecore Biomedical, Inc. | DZE |
| Jul 19, 2004 | K041324 | CALMATRIX CALCIUM SULFATE BONE GRAFT BINDER Lifecore Biomedical, Inc. | LYC |
| Nov 26, 2003 | K032774 | RENOVA INTERNAL HEX IMPLANT SYSTEM Lifecore Biomedical, Inc. | DZE |
| Sep 17, 2003 | K032495 | THE LIFECORE STAGE-1 ANGLED ABUTMENT SYSTEM Lifecore Biomedical, Inc. | DZE |
| May 16, 2001 | K002037 | LIFECORE BIOMEDICAL DENTAL IMPLANT SYSTEMS Lifecore Biomedical, Inc. | DZE |
| Jan 12, 2001 | K003226 | THE LIFECORE STAGE-1 SINGLE STAGE RBM DENTAL IMPLANT SYSTEM Lifecore Biomedical, Inc. | DZE |
| Mar 8, 2000 | K993894 | LIFECORE SINGLE TOOTH ABUTMENT SYSTEM Lifecore Biomedical, Inc. | DZE |
| Feb 29, 2000 | K994205 | MODIFICATION OF REGULAR DIAMETER SINGLE STAGE (RDS) TPS DENTAL IMPLANT SYSTEM Lifecore Biomedical, Inc. | DZE |
| Jul 14, 1999 | K991114 | REGULAR DIAMETER SINGLE STAGE (RDS) TPS DENTAL IMPLANT SYSTEM Lifecore Biomedical, Inc. | DZE |
| May 27, 1997 | K970776 | LIFECORE O-RING ABUTMENT;LIFECORE DALLA BONA ABUTMENT Lifecore Biomedical, Inc. | DZE |
| Feb 25, 1997 | K965135 | LIFECORE CONICAL ABUTMENT Lifecore Biomedical, Inc. | DZE |
| Jun 28, 1996 | K961511 | HAPSET HYDROXYLAPATITE BONE GRAFT PLASTER Lifecore Biomedical, Inc. | LZK |
| Mar 28, 1996 | K960288 | HA & TPS RESTORE SELF TAPPING DENTAL IMPLANT SYSTEM Lifecore Biomedical, Inc. | DZE |
| Feb 23, 1996 | K954512 | RESTORE SELF TAPPING DENTAL IMPLANT SYSTEM Lifecore Biomedical, Inc. | DZE |
| Jan 23, 1996 | K955096 | CAPSET CALCIUM SULFATE BONE GRAFT PLASTER Lifecore Biomedical, Inc. | LYC |
| Jan 11, 1996 | K954865 | RESTORE HA DENTAL IMPLANT SYSTEM Lifecore Biomedical, Inc. | DZE |
| Jan 11, 1996 | K954819 | RESTORE TPS DENTAL IMPLANT SYSTEM SUSTAIN TPS DENTAL IMPLANT SYSTEM Lifecore Biomedical, Inc. | DZE |
| Aug 30, 1995 | K950624 | HA- AND TPS- RESTORE SELF TAPPING DENTAL IMPLANT SYSTEM Lifecore Biomedical, Inc. | DZE |
| Apr 10, 1995 | K943186 | CAPSET CALCIUM SULFATE BONE GRAFT PLASTER Lifecore Biomedical, Inc. | LYC |
| Mar 31, 1995 | K951111 | RESTORE SELF TAPPING DENTAL IMPLANT SYSTEM (3.4MM) Lifecore Biomedical, Inc. | DZE |
| Feb 28, 1995 | K944069 | RESTORE TPS LHEX CYLINDER ENDOSSEOUS IMPLANT SYSTEM Lifecore Biomedical, Inc. | DZE |
| Feb 2, 1995 | K944068 | RESTORE SELF TAPPING DENTAL IMPLANT SYST (5, 5.5,6MM) Lifecore Biomedical, Inc. | DZE |
| Jul 22, 1994 | K941554 | SUSTAIN HEX HA-COATED CYLINDER ENDOSSEOUS IMPLANT SYSTEM Lifecore Biomedical, Inc. | DZE |
| Jul 12, 1994 | K931468 | RESTORE HEX CYLINDER ENDOSSEOUS SYSTEM Lifecore Biomedical, Inc. | DZE |
| Feb 3, 1994 | K914137 | HA-BIONTEGRATED DENTAL IMPLANT SYSTEMS Lifecore Biomedical, Inc. | DZE |
| May 1, 1991 | K910432 | HAPSET HYDROXYLAPATITE BONE GRAFT PLASTER Lifecore Biomedical, Inc. | LYC |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 20, 2004 | Lifecore Biomedical, Inc. TefGen is an implant material which is intended to be used as a temporary space-making barrier over bone or other tissue. Terminated |
LYC | K935137 |