510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Lifecore Biomedical LLC

Chaska, MN, US

LIFECORE BIOMEDICAL LLC appears in FDA device records in Chaska, MN. FDA records list 34 510(k) clearances between and , 3 PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
34
PMA records
3
Recall records
1
Registered establishments
1

510(k) clearance history

FDA records hold 34 510(k) clearances for Lifecore Biomedical LLC between 1991 and 2007. The busiest year on record is 1996, with 6. The most recent is 2007, with 4.

Clearances by year, as a table
510(k) clearance decisions for Lifecore Biomedical LLC, by decision year
YearClearances
19911
19943
19955
19966
19972
19991
20002
20012
20032
20041
20052
20063
20074
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K073032PRIMACONNEX SD ESTHETIC CONTOUR ZI ABUTMENTSNHASubstantially Equivalent
K072241PRIMACONNEX CAD/CAM ABUTMENT SYSTEMNHASubstantially Equivalent
K072768RESTORE, STAGE-1, RENOVA PRIMASOLO AND PRIMACONNEX DENTAL IMPLANTSDZESubstantially Equivalent
K072572PRIMACONNEX RD AND WD ESTHETIC CONTOUR ZI ABUTMENTSNHASubstantially Equivalent
K062876PRIMACONNEX CERAMIC ABUTMENTSNHASubstantially Equivalent
K060530SD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING. MODEL 45301. RD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING, MODEL 45302.ELLSubstantially Equivalent
K053643STAGE- 1 TEMPORARY/HEALING CAP, MODEL 42021-42026NHASubstantially Equivalent
K051614PRIMACONNEX INTERNAL CONNECTION IMPLANT SYSTEM, PRIMACONNEX INTERNAL CONNECTION PROSTHETICSDZESubstantially Equivalent
K050506PRIMASOLO ONE-PIECE IMPLANTS & HEALING CAPSDZESubstantially Equivalent
K041324CALMATRIX CALCIUM SULFATE BONE GRAFT BINDERLYCSubstantially Equivalent
K032774RENOVA INTERNAL HEX IMPLANT SYSTEMDZESubstantially Equivalent
K032495THE LIFECORE STAGE-1 ANGLED ABUTMENT SYSTEMDZESubstantially Equivalent
K002037LIFECORE BIOMEDICAL DENTAL IMPLANT SYSTEMSDZESubstantially Equivalent
K003226THE LIFECORE STAGE-1 SINGLE STAGE RBM DENTAL IMPLANT SYSTEMDZESubstantially Equivalent
K993894LIFECORE SINGLE TOOTH ABUTMENT SYSTEMDZESubstantially Equivalent
K994205MODIFICATION OF REGULAR DIAMETER SINGLE STAGE (RDS) TPS DENTAL IMPLANT SYSTEMDZESubstantially Equivalent
K991114REGULAR DIAMETER SINGLE STAGE (RDS) TPS DENTAL IMPLANT SYSTEMDZESubstantially Equivalent
K970776LIFECORE O-RING ABUTMENT;LIFECORE DALLA BONA ABUTMENTDZESubstantially Equivalent
K965135LIFECORE CONICAL ABUTMENTDZESubstantially Equivalent
K961511HAPSET HYDROXYLAPATITE BONE GRAFT PLASTERLZKSubstantially Equivalent
K960288HA & TPS RESTORE SELF TAPPING DENTAL IMPLANT SYSTEMDZESubstantially Equivalent
K954512RESTORE SELF TAPPING DENTAL IMPLANT SYSTEMDZESubstantially Equivalent
K955096CAPSET CALCIUM SULFATE BONE GRAFT PLASTERLYCSubstantially Equivalent
K954865RESTORE HA DENTAL IMPLANT SYSTEMDZESubstantially Equivalent
K954819RESTORE TPS DENTAL IMPLANT SYSTEM SUSTAIN TPS DENTAL IMPLANT SYSTEMDZESubstantially Equivalent
K950624HA- AND TPS- RESTORE SELF TAPPING DENTAL IMPLANT SYSTEMDZESubstantially Equivalent
K943186CAPSET CALCIUM SULFATE BONE GRAFT PLASTERLYCSubstantially Equivalent
K951111RESTORE SELF TAPPING DENTAL IMPLANT SYSTEM (3.4MM)DZESubstantially Equivalent
K944069RESTORE TPS LHEX CYLINDER ENDOSSEOUS IMPLANT SYSTEMDZESubstantially Equivalent
K944068RESTORE SELF TAPPING DENTAL IMPLANT SYST (5, 5.5,6MM)DZESubstantially Equivalent
K941554SUSTAIN HEX HA-COATED CYLINDER ENDOSSEOUS IMPLANT SYSTEMDZESubstantially Equivalent
K931468RESTORE HEX CYLINDER ENDOSSEOUS SYSTEMDZESubstantially Equivalent
K914137HA-BIONTEGRATED DENTAL IMPLANT SYSTEMSDZESubstantially Equivalent
K910432HAPSET HYDROXYLAPATITE BONE GRAFT PLASTERLYCSubstantially Equivalent

Registered establishments

FDA registered establishments for Lifecore Biomedical LLC, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
21840021000115753LIFECORE BIOMEDICAL LLC3515 LYMAN BLVD., CHASKA, MN 55318 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-1073-04TefGen is an implant material which is intended to be used as a temporary space-making barrier over bone or other tissue.Packaged product labeled catalog #TFS30, lot number 002419 actually contained catalog #TFR60, lot number 002441and vice versa.Terminated

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Data as of , FDA export datePage updated Source: openFDA, public domain