RESTORE SELF TAPPING DENTAL IMPLANT SYST (5, 5.5,6MM)— 510(k) K944068

Substantially Equivalent

Lifecore Biomedical, Inc.

FDA 510(k) clearance K944068 for RESTORE SELF TAPPING DENTAL IMPLANT SYST (5, 5.5,6MM), Substantially Equivalent on 1995-02-02. Applicant: Lifecore Biomedical, Inc..

Clearance details

Applicant: Lifecore Biomedical, Inc.
Product code: Code DZE
Advisory panel: Dental
Date received: 1994-08-15
Decision date: 1995-02-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chaska, MN, US

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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, 2020-01-01 through 2026-04-23. 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.