AMERICAN DENTAL LASER SINGLE USE CONTACT 320 HANDP— 510(k) K923539

Substantially Equivalent

American Dental Laser, Inc.

FDA 510(k) clearance K923539 for AMERICAN DENTAL LASER SINGLE USE CONTACT 320 HANDP, Substantially Equivalent on 1992-10-28. Applicant: American Dental Laser, Inc..

Clearance details

Applicant: American Dental Laser, Inc.
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 1992-07-16
Decision date: 1992-10-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Attleboro, MA, US

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Adverse events under product code GEX

product code GEX

Death: 33
Injury: 3,045
Malfunction: 12,903
Other: 25
Total: 16,006

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.