STAGE- 1 TEMPORARY/HEALING CAP, MODEL 42021-42026— 510(k) K053643

Substantially Equivalent

Lifecore Biomedical, Inc.

FDA 510(k) clearance K053643 for STAGE- 1 TEMPORARY/HEALING CAP, MODEL 42021-42026, Substantially Equivalent on 2006-01-23. Applicant: Lifecore Biomedical, Inc..

Clearance details

Applicant: Lifecore Biomedical, Inc.
Product code: Code NHA
Advisory panel: Dental
Date received: 2005-12-30
Decision date: 2006-01-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Chaska, MN, US

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Adverse events under product code NHA

product code NHA

Injury: 1,270
Malfunction: 2,860
Total: 4,130

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.