RESTORE, STAGE-1, RENOVA PRIMASOLO AND PRIMACONNEX DENTAL IMPLANTS— 510(k) K072768
Substantially EquivalentLifecore Biomedical, Inc.
FDA 510(k) clearance K072768 for RESTORE, STAGE-1, RENOVA PRIMASOLO AND PRIMACONNEX DENTAL IMPLANTS, Substantially Equivalent on 2007-10-23. Applicant: Lifecore Biomedical, Inc.. Device class: 2.
Clearance details
- Applicant
- Lifecore Biomedical, Inc.
- Product code
- Code DZE
- Device class
- Class 2
- Regulation
- 21 CFR 872.3640
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Chaska, MN, US
Recent devices under product code DZE
view allMore clearances from Lifecore Biomedical, Inc.
view all- K073032 — PRIMACONNEX SD ESTHETIC CONTOUR ZI ABUTMENTS
- K072241 — PRIMACONNEX CAD/CAM ABUTMENT SYSTEM
- K072572 — PRIMACONNEX RD AND WD ESTHETIC CONTOUR ZI ABUTMENTS
- K062876 — PRIMACONNEX CERAMIC ABUTMENTS
- K060530 — SD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING. MODEL 45301. RD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING, MODEL 45302.
Adverse events under product code DZE
product code DZE- Death
- 28
- Injury
- 3,367,041
- Malfunction
- 19,958
- Other
- 13
- Total
- 3,387,040
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K072768
K-number listed on FDA's recall record- Z-1179-2018 — STAGE-1¿ RDS COC Abutment Plastic Sleeve, Non-Lock, Multi-Unit; Catalog Number: S2437-01-1K
- Z-0727-2018 — Stage-1¿ RDS Indexed Abutment for RDS Stage-1¿ Single Stage Implants Keystone s implants are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cement retained, screw retained, or overdenture restorations and terminal or intermediate abutment support for fixed bridgework.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K072768.
Data sourced from openFDA. This site is unofficial and independent of the FDA.