GOLD AIR, GOLD LIGHT— 510(k) K854645

Substantially Equivalent

Alpine Dental Equipment Co.

FDA 510(k) clearance K854645 for GOLD AIR, GOLD LIGHT, Substantially Equivalent on 1986-03-12. Applicant: Alpine Dental Equipment Co..

Clearance details

Applicant: Alpine Dental Equipment Co.
Product code: Code EFB
Advisory panel: Dental
Date received: 1985-11-19
Decision date: 1986-03-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: East Orange, NJ, US

Download summary PDF View on FDA.gov ↗

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.