Synea Fusion Handpieces (Intensiv & Profin)— 510(k) K242179
Substantially EquivalentW&H Dentalwerk Bürmoos GmbH
FDA 510(k) clearance K242179 for Synea Fusion Handpieces (Intensiv & Profin), Substantially Equivalent on 2025-02-28. Applicant: W&H Dentalwerk Bürmoos GmbH. Device class: 1.
Clearance details
- Applicant
- W&H Dentalwerk Bürmoos GmbH
- Product code
- Code EFB
- 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 EFB
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- K241074 — High-speed Air Turbine Handpieces (SCHG01, SCHG03, SCHG18, SCHF19, SCHF22), Dental Low Speed Handpieces including Straight and Geared Angle Handpieces and Air Motors (Straight Handpieces: SCHD05-S, SCHD16-S, SCHD17-S, SCHD24-S, SCHD27-S Geared Angle Handpieces: SCHD05-C, SCHD06-C, SCHD16-C, SCHD17-C, SCHD24-C, SCHD27-C, SCHD29-S, SCHB4, SCHB5, SCHB20, SCHB64 Air Motors: SCHD16-M, SCHD17-M, SCHD24-M, SCHD27-M)
- K241880 — Air Powered Tooth Polishing System (Perio-Mate); Air Powered Tooth Polishing System (Perio Mate Nozzle Tip)
More clearances from W&H Dentalwerk Bürmoos GmbH
view allAdverse events under product code EFB
product code EFB- Injury
- 133
- Malfunction
- 562
- Total
- 695
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.