DENTEC LD 15 DIODE LASER— 510(k) K990680

Substantially Equivalent

Dentek Lasersystems Produktions Ges.M.B.H.

FDA 510(k) clearance K990680 for DENTEC LD 15 DIODE LASER, Substantially Equivalent on 1999-07-30. Applicant: Dentek Lasersystems Produktions Ges.M.B.H..

Clearance details

Applicant: Dentek Lasersystems Produktions Ges.M.B.H.
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 1999-03-02
Decision date: 1999-07-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Graz, AT

Download summary PDF View on FDA.gov ↗

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.