XENEX DENTAL ROULETTE— 510(k) K880485

Name: FDA 510(k) clearance K880485
Creator: U.S. Food and Drug Administration
Published: 1988-05-02

Substantially Equivalent

G & A Industries, Inc.

FDA 510(k) clearance K880485 for XENEX DENTAL ROULETTE, Substantially Equivalent on 1988-05-02. Applicant: G & A Industries, Inc.. Device class: 1.

Clearance details

Applicant: G & A Industries, Inc.
Product code: Code EFW
Device class: Class 1
Regulation: 21 CFR 872.6855
Advisory panel: Dental
Date received: 1988-02-04
Decision date: 1988-05-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: East Brunswick, NJ, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code EFW

product code EFW

Injury: 143
Malfunction: 698
Total: 841

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.