SURGICAL CONTRA-ANGEL HANDPIECES TYPES WS-56E,WS-75E/KM,WS-92 E/3,SURGICAL STRAIGHT HANDPIECES TYPES, S-9, S-10, S-11— 510(k) K011061

Substantially Equivalent

W&H Dentalwerk Buermoos GmbH

FDA 510(k) clearance K011061 for SURGICAL CONTRA-ANGEL HANDPIECES TYPES WS-56E,WS-75E/KM,WS-92 E/3,SURGICAL STRAIGHT HANDPIECES TYPES, S-9, S-10, S-11, Substantially Equivalent on 2001-06-28. Applicant: W&H Dentalwerk Buermoos GmbH.

Clearance details

Applicant: W&H Dentalwerk Buermoos GmbH
Product code: Code EGS
Advisory panel: Dental
Date received: 2001-04-06
Decision date: 2001-06-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Buermoos, AT

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Adverse events under product code EGS

product code EGS

Injury: 356
Malfunction: 759
Total: 1,115

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.