CONTOUR HEALER— 510(k) K112099

Substantially Equivalent

Contour Healer, LLC

FDA 510(k) clearance K112099 for CONTOUR HEALER, Substantially Equivalent on 2012-02-03. Applicant: Contour Healer, LLC.

Clearance details

Applicant: Contour Healer, LLC
Product code: Code NHA
Advisory panel: Dental
Date received: 2011-07-22
Decision date: 2012-02-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Virginia Beach, VA, US

Download summary PDF View on FDA.gov ↗

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.