Cleared Traditional

W&H Assistina Twin

K171553 · W&H Dentalwerk Buermoos GmbH · Dental
Dec 2017
Decision
192d
Days
Class 1
Risk

About This 510(k) Submission

K171553 is an FDA 510(k) clearance for the W&H Assistina Twin, a Handpiece, Air-powered, Dental (Class I — General Controls, product code EFB), submitted by W&H Dentalwerk Buermoos GmbH (Buermoos, AT). The FDA issued a Cleared decision on December 8, 2017, 192 days after receiving the submission on May 30, 2017. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number K171553 FDA.gov
FDA Decision Cleared SESE
Date Received May 30, 2017
Decision Date December 08, 2017
Days to Decision 192 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EFB — Handpiece, Air-powered, Dental
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.4200

Similar Devices — EFB Handpiece, Air-powered, Dental

All 260
Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS, TM-ES, TM-SG20, TM-X25, TM-BB, TM-IC, TM-RA41)
K251388 · Foshan Topmed Dental Co., Ltd. · Jan 2026
High speed air turbine handpiece
K251389 · Foshan Topmed Dental Co., Ltd. · Jan 2026
Synea Fusion Handpieces (Intensiv & Profin)
K242179 · W&H Dentalwerk B?rmoos GmbH · Feb 2025
Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L)
K240337 · Guangdong Jinme Medical Technology Co., Ltd. · Nov 2024
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)
K241074 · Foshan Soco Precision Instrument Co., Ltd. · Nov 2024
Air Powered Tooth Polishing System (Perio-Mate); Air Powered Tooth Polishing System (Perio Mate Nozzle Tip)
K241880 · Nakanishi, Inc. · Sep 2024