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 EquivalentW&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. Device class: 1.
Clearance details
- Applicant
- W&H Dentalwerk Buermoos GmbH
- Product code
- Code EGS
- Device class
- Class 1
- Regulation
- 21 CFR 872.4200
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Buermoos, AT
Recent devices under product code EGS
view allMore clearances from W&H Dentalwerk Buermoos GmbH
view all- K253776 — Implantmed Plus II & Piezomed Plus II Module
- K243280 — Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various tips) and accessories)
- K201703 — PROXEO Twist Cordless Polishing System PL-40 H
- K181858 — Electric Handpiece Motor
- K171553 — W&H Assistina Twin
Adverse events under product code EGS
product code EGS- Injury
- 356
- Malfunction
- 759
- Total
- 1,115
Source: openFDA MAUDE database, through . 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.