LYNX LOW-SPEED HANDPIECE— 510(k) K900798

Substantially Equivalent

Air Motors Technologies

FDA 510(k) clearance K900798 for LYNX LOW-SPEED HANDPIECE, Substantially Equivalent on 1990-06-27. Applicant: Air Motors Technologies.

Clearance details

Applicant: Air Motors Technologies
Product code: Code EFB
Advisory panel: Dental
Date received: 1990-02-20
Decision date: 1990-06-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shelomi, IL

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.