MASTERTORQUE LUX 8900 L— 510(k) K130560

Clearance details

Applicant

Kaltenbach & Voigt GmbH

Product code

Code EFB

Device class

Class 1

Regulation

21 CFR 872.4200

Advisory panel

Dental

Date received

2013-03-04

Decision date

2013-09-27

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Biberach, DE

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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 →