CONTRA-ANGLE HANDPIECE KOMET OS30— 510(k) K090548

Clearance details

Applicant

W&H Dentalwerk Buermoos GmbH

Product code

Code EFB

Device class

Class 1

Regulation

21 CFR 872.4200

Advisory panel

Dental

Date received

2009-03-02

Decision date

2009-06-30

Decision

Substantially Equivalent

Clearance type

Abbreviated

Location

Buermoos, AT

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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 →