SIROLASER ADVANCE, SIROLASER XTEND, SIROLASER XTEND UPGRADED, FONALASER— 510(k) K103753

Clearance details

Applicant

Sirona Dental Systems GmbH

Product code

Code GEX

Device class

Class 2

Regulation

21 CFR 878.4810

Advisory panel

General, Plastic Surgery

Date received

2010-12-23

Decision date

2011-02-15

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Bensheim, DE

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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 →