PRIMACONNEX SD ESTHETIC CONTOUR ZI ABUTMENTS— 510(k) K073032
Substantially EquivalentLifecore Biomedical, Inc.
FDA 510(k) clearance K073032 for PRIMACONNEX SD ESTHETIC CONTOUR ZI ABUTMENTS, Substantially Equivalent on 2007-11-16. Applicant: Lifecore Biomedical, Inc.. Device class: 2.
Clearance details
- Applicant
- Lifecore Biomedical, Inc.
- Product code
- Code NHA
- Device class
- Class 2
- Regulation
- 21 CFR 872.3630
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Chaska, MN, US
Recent devices under product code NHA
view allMore clearances from Lifecore Biomedical, Inc.
view all- K072241 — PRIMACONNEX CAD/CAM ABUTMENT SYSTEM
- K072768 — RESTORE, STAGE-1, RENOVA PRIMASOLO AND PRIMACONNEX DENTAL IMPLANTS
- 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 NHA
product code NHA- Injury
- 1,270
- Malfunction
- 2,860
- Total
- 4,130
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.