AQUALIZER MOUTHPIECE— 510(k) K831793

Substantially Equivalent

Martin D. Lerman

FDA 510(k) clearance K831793 for AQUALIZER MOUTHPIECE, Substantially Equivalent on 1983-08-12. Applicant: Martin D. Lerman.

Clearance details

Applicant: Martin D. Lerman
Product code: Code KMY
Advisory panel: Dental
Date received: 1983-06-03
Decision date: 1983-08-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code KMY

product code KMY

Injury: 1,457
Total: 1,457

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.