Surgical Contra-Angel Handpieces Types Ws-56E, Ws-75E/Km, Ws-92 E/3, Surgical Straight Handpieces Types, S-9, S-10, S-11

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K011061 ↗

FDA Product Code

EGS

Device Class

Class I

Regulation

21 CFR Part 872.4200

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Implantmed Plus II & Piezomed Plus II Module

  Class II

  FDA 510(k) K253776 Active Cleared 18 Jun 2026

• W&H Assistina Twin

  Class I

  FDA 510(k) K171553 Active Cleared 8 Dec 2017

• PROXEO Twist Cordless Polishing System PL-40 H

  Class I

  FDA 510(k) K201703 Active Cleared 24 Feb 2021

• Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various tips) and accessories)

  Class II

  FDA 510(k) K243280 Active Cleared 3 Jul 2025

• Surgical Handpieces, Mikro Saw Handpieces Open recall

  Class II

  FDA 510(k) K080939 Active Cleared 29 Jul 2008

• Prosthodontic Screwdriver, Model Ia-400

  Class I

  FDA 510(k) K100600 Active Cleared 9 Jul 2010

See all devices from W&H Dentalwerk Buermoos GmbH →

• Are these handpieces designed for use in both dental clinics and surgical operating rooms, and how does that affect their versatility?

  Yes, these handpieces are explicitly designed for use in both dental clinics and operating rooms, making them versatile for a range of procedures. The contra-angle models (WS-56E, WS-75E/KM, WS-92E/3) and straight models (S-9, S-10, S-11) are engineered for precision cutting, cavity removal, and polishing in restorative and surgical dentistry. Their adaptability to different clinical environments ensures they can be used for high-speed rotary actions required in both settings.

• How do I determine whether a specific handpiece model is single-use or reusable, and what sterilization methods are compatible?

  The manufacturer specifies whether each model is single-use or reusable, though this detail isn’t explicitly listed in the provided data. However, the handpieces are compatible with autoclave or chemical sterilization methods if they are reusable and require sterilization prior to first use. Since they are non-sterile as supplied, users must follow the manufacturer’s instructions to ensure proper sterilization before clinical use.

• What types of procedures are these handpieces best suited for, and how do the contra-angle and straight models differ in their applications?

  The contra-angle handpieces (WS-56E, WS-75E/KM, WS-92E/3) are designed for procedures requiring angled access, such as working in confined oral spaces. The straight handpieces (S-9, S-10, S-11) provide direct, linear instrumentation, ideal for tasks like tooth preparation and cavity removal where precision and alignment are critical. Both types are optimized for high-speed rotary action, enabling efficient restorative and surgical dentistry procedures.

• Are these handpieces safe to use in an MRI environment, and why does this matter for clinical settings?

  Yes, these handpieces are MRI-safe, as they are explicitly labeled as non-ferromagnetic. This is important for clinical settings where patients may require MRI scans post-procedure, as it eliminates the risk of interference or injury from metallic components during imaging. The non-ferromagnetic design ensures compatibility with MRI environments without compromising the device’s functionality.

• What regulatory pathways have these handpieces undergone, and how does this affect their use in different markets?

  These handpieces have undergone FDA 510(k) clearance, as well as authorization under the Medical Device Directive (MDD) and the Medical Device Regulation (MDR). This regulatory framework ensures compliance with stringent safety and performance standards in the U.S. and European markets, respectively. The FDA clearance and MDR compliance validate their suitability for use in dental clinics and operating rooms, providing confidence in their reliability and adherence to global medical device regulations.