Not currently registered with FDA under this name
Lifecore Biomedical, Inc.
Chaska, MN, United States. Named as applicant on 34 dental 510(k) clearances between 1991 and 2007. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 341991–2007
- Markets registered in
- 661 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 1990–2026
Registered in 6 markets
Where regulators' registries name Lifecore Biomedical, Inc. as the manufacturer or the registration holder of a device.
RegisteredHome: United StatesOne marker per market
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Applicant | Lifecore Biomedical, Inc. | 34 clearances | 1991–2007 | Below |
| South Korea | MFDS | Manufacturer | LifeCore BiomedicalLifecore Biomedical, Inc. · Lifecore Biomedical, Inc · +2 | 20 | 1999–2005 | Pure Global AI |
| Canada | Health Canada | Registration holder | LIFECORE BIOMEDICAL, INC. | 18 | 1999–2000 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | LIFECORE BIOMEDICALLIFECORE BIOMEDICAL INC | 11 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | LIFECORE BIOMEDICAL, INC.Lifecore Biomedical, LLC | 9 | 2007–2013 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | Lifecore BiomedicalLifecore Biomedical, LLC · Lifecore Biomedical, LLC. | 3 | — | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
510(k) clearances
Clearances on which FDA names Lifecore Biomedical, Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 16 Nov 2007 | K073032 | PRIMACONNEX SD ESTHETIC CONTOUR ZI ABUTMENTS | NHA Endosseous Dental Implant Abutment |
| 9 Nov 2007 | K072241 | PRIMACONNEX CAD/CAM ABUTMENT SYSTEM | NHA Endosseous Dental Implant Abutment |
| 23 Oct 2007 | K072768 | RESTORE, STAGE-1, RENOVA PRIMASOLO AND PRIMACONNEX DENTAL IMPLANTS | DZE Root-Form Endosseous Implant |
| 5 Oct 2007 | K072572 | PRIMACONNEX RD AND WD ESTHETIC CONTOUR ZI ABUTMENTS | NHA Endosseous Dental Implant Abutment |
| 1 Nov 2006 | K062876 | PRIMACONNEX CERAMIC ABUTMENTS | NHA Endosseous Dental Implant Abutment |
| 22 May 2006 | K060530 | SD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING. MODEL 45301. RD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING, MODEL 45302. | ELL Porcelain Teeth |
| 23 Jan 2006 | K053643 | STAGE- 1 TEMPORARY/HEALING CAP, MODEL 42021-42026 | NHA Endosseous Dental Implant Abutment |
| 9 Sep 2005 | K051614 | PRIMACONNEX INTERNAL CONNECTION IMPLANT SYSTEM, PRIMACONNEX INTERNAL CONNECTION PROSTHETICS | DZE Root-Form Endosseous Implant |
| 15 Apr 2005 | K050506 | PRIMASOLO ONE-PIECE IMPLANTS & HEALING CAPS | DZE Root-Form Endosseous Implant |
| 14 Feb 2005 | K042730 | CALFORMA CALCIUM SULFATE BONE GRAFT BARRIER, MODEL 0.5G/1.0G | LYC Synthetic Bone Grafting Material |
| 19 Jul 2004 | K041324 | CALMATRIX CALCIUM SULFATE BONE GRAFT BINDER | LYC Synthetic Bone Grafting Material |
| 26 Nov 2003 | K032774 | RENOVA INTERNAL HEX IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 17 Sep 2003 | K032495 | THE LIFECORE STAGE-1 ANGLED ABUTMENT SYSTEM | DZE Root-Form Endosseous Implant |
| 16 May 2001 | K002037 | LIFECORE BIOMEDICAL DENTAL IMPLANT SYSTEMS | DZE Root-Form Endosseous Implant |
| 12 Jan 2001 | K003226 | THE LIFECORE STAGE-1 SINGLE STAGE RBM DENTAL IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 8 Mar 2000 | K993894 | LIFECORE SINGLE TOOTH ABUTMENT SYSTEM | DZE Root-Form Endosseous Implant |
| 29 Feb 2000 | K994205 | MODIFICATION OF REGULAR DIAMETER SINGLE STAGE (RDS) TPS DENTAL IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 14 Jul 1999 | K991114 | REGULAR DIAMETER SINGLE STAGE (RDS) TPS DENTAL IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 27 May 1997 | K970776 | LIFECORE O-RING ABUTMENT;LIFECORE DALLA BONA ABUTMENT | DZE Root-Form Endosseous Implant |
| 25 Feb 1997 | K965135 | LIFECORE CONICAL ABUTMENT | DZE Root-Form Endosseous Implant |
| 28 Mar 1996 | K960288 | HA & TPS RESTORE SELF TAPPING DENTAL IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 23 Feb 1996 | K954512 | RESTORE SELF TAPPING DENTAL IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 23 Jan 1996 | K955096 | CAPSET CALCIUM SULFATE BONE GRAFT PLASTER | LYC Synthetic Bone Grafting Material |
| 11 Jan 1996 | K954865 | RESTORE HA DENTAL IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 11 Jan 1996 | K954819 | RESTORE TPS DENTAL IMPLANT SYSTEM SUSTAIN TPS DENTAL IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 30 Aug 1995 | K950624 | HA- AND TPS- RESTORE SELF TAPPING DENTAL IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 10 Apr 1995 | K943186 | CAPSET CALCIUM SULFATE BONE GRAFT PLASTER | LYC Synthetic Bone Grafting Material |
| 31 Mar 1995 | K951111 | RESTORE SELF TAPPING DENTAL IMPLANT SYSTEM (3.4MM) | DZE Root-Form Endosseous Implant |
| 28 Feb 1995 | K944069 | RESTORE TPS LHEX CYLINDER ENDOSSEOUS IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 2 Feb 1995 | K944068 | RESTORE SELF TAPPING DENTAL IMPLANT SYST (5, 5.5,6MM) | DZE Root-Form Endosseous Implant |
| 22 Jul 1994 | K941554 | SUSTAIN HEX HA-COATED CYLINDER ENDOSSEOUS IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 12 Jul 1994 | K931468 | RESTORE HEX CYLINDER ENDOSSEOUS SYSTEM | DZE Root-Form Endosseous Implant |
| 3 Feb 1994 | K914137 | HA-BIONTEGRATED DENTAL IMPLANT SYSTEMS | DZE Root-Form Endosseous Implant |
| 1 May 1991 | K910432 | HAPSET HYDROXYLAPATITE BONE GRAFT PLASTER | LYC Synthetic Bone Grafting Material |
Some of these clearances are listed with FDA today by another company: Keystone Dental Inc. (29).
Sources
FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record of the most recent filing, which can be a US agent.