AQUA DENT HANDPIECE EXTENSION AND AQUA DENT DISP.— 510(k) K882135

Substantially Equivalent

Vita Dental Co.

FDA 510(k) clearance K882135 for AQUA DENT HANDPIECE EXTENSION AND AQUA DENT DISP., Substantially Equivalent on 1988-06-22. Applicant: Vita Dental Co..

Clearance details

Applicant: Vita Dental Co.
Product code: Code EFB
Advisory panel: Dental
Date received: 1988-05-20
Decision date: 1988-06-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Decorah, IA, US

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Adverse events under product code EFB

product code EFB

Injury: 133
Malfunction: 562
Total: 695

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.