Handpiece, Air-powered, Dental
Dental · 21 CFR 872.4200
Recent MDR events
2,071 adverse event reports on file
- Midwest® T1 Energo 1:5 LJul 31, 2026MalfunctionSirona Dental Systems Gmbh9614977-2026-00129
- Henry ScheinJul 30, 2026InjuryTtbio Corp.3010364969-2026-00002
- Midwest® E Pro 1:5Jul 30, 2026MalfunctionSirona Dental Systems Gmbh9614977-2026-00126
- Henry ScheinJul 30, 2026InjuryTtbio Corp.3010364969-2026-00004
- MedidentaJul 30, 2026InjuryTtbio Corp.3010364969-2026-00003
- NSKJul 29, 2026InjuryNakanishi Inc.9611253-2026-00040
- NSKJul 29, 2026InjuryNakanishi Inc.9611253-2026-00041
- NSKJul 29, 2026InjuryNakanishi Inc.9611253-2026-00042
- GENTLEpower Lux Winkelstück 25LPAJul 29, 2026MalfunctionKavo Dental Gmbh3003637274-2026-00030
- Midwest E Plus 1:5Jul 29, 2026MalfunctionSirona Dental Systems Gmbh9614977-2026-00123
Event type breakdown
Recalls
8 recall events for this product code
- Coltene Whaledent IncOpen, ClassifiedMar 2, 2023
SciCan STATIS SL S10001 Dental Handpieces-Intended for the removal of carious material, reducing hard tooth structure, cavity preparation, finishing tooth prepa
Screw connection between the turbine head and the push button may loosen and fall off during the treatment, and increase the risk of swallowing or inhaling part of the turbines head or the push button
Z-1208-2023 · View FDA record ↗ - MTI Precision Products LLC.TerminatedJul 12, 2014
Lynx TM20 Torquemaster Low Speed Handpiece MTI Dental Products
Sharp edge on the body/housing of the Lynx TM20 TorqueMaster Low Speed Handpiece.
Z-2044-2014 · View FDA record ↗ - Kavo America CorporationTerminatedDec 19, 2006
KaVo QUATTROcare Spray, 500 ml aerosol can; a maintenance spray for lubrication of KaVo turbines, air motors, straight and contra-angle dental handpieces. For
The QUATTROcare Spray cans may allow the gas (propane) to escape from the can under certain circumstances. In rare cases, when an ignition source is nearby, this escape of gas may lead to the emission of smoke and possibly flames from the can which could lead to property damage or personnel injury.
Z-0289-2007 · View FDA record ↗ - DentSply -Professional DivisionTerminatedJul 20, 2004
Midwest Tradition PB Non-Fiber Optic High Speed Handpiece with Push Button Chuck (4 tube connection), catalog #790044; Manufactured for DENTSPLY Professional, A
Small cracks in the dental handpiece's chuck could allow the dental burs to drift out of the chuck over time.
Z-0154-04 · View FDA record ↗ - DentSply -Professional DivisionTerminatedJul 20, 2004
Midwest Tradition PB Fiber Optic High Speed Handpiece with Push Button Chuck (5 tube connection), catalog #790045 and 790045T; Manufactured for DENTSPLY Profess
Small cracks in the dental handpiece's chuck could allow the dental burs to drift out of the chuck over time.
Z-0155-04 · View FDA record ↗ - DentSply -Professional DivisionTerminatedJul 20, 2004
Midwest XGT High Speed Handpiece with Fiber Optics and Push Button Chuck, catalog #790000; Manufactured for DENTSPLY Professional, A Division of DENTSPLY Intern
Small cracks in the dental handpiece's chuck could allow the dental burs to drift out of the chuck over time.
Z-0156-04 · View FDA record ↗ - DentSply -Professional DivisionTerminatedJul 20, 2004
Midwest Tradition PB High Speed Handpiece with Push Button Chuck, catalog #790042; Manufactured for DENTSPLY Professional, A Division of DENTSPLY International,
Small cracks in the dental handpiece's chuck could allow the dental burs to drift out of the chuck over time.
Z-0157-04 · View FDA record ↗ - Nakanishi Inc.TerminatedUnknown
Diamond Coated Tips and Burs are accessories to the air powered dental handpiece (S-MAX pico)
Through an error, the labeling failed to include the symbol or other text indicating that the diamond coated tips were single use only. A contributing factor to this error is that in other markets such as Japan, the diamond coated tips are multiple use and are not limited to single use only. The tips are stainless steel with a coating of fine diamond powder. The tips are sold non-sterile and are to be sterilized prior to first use. The tips were cleared as single use only. This problem was discovered during an ongoing, proactive, quality system improvement plan that was initiated by Nakanishi in October 2014. Because the correct instructions for sterilization are not available, it is possible that the devices might not be sterile prior to use. The absence of the single use statement introduces a risk of cross-contamination if the tips are reprocessed and reused.
Z-2674-2016 · View FDA record ↗
Registered firms
305 firms currently registered for this product code
Nakanishi Inc.
Kanuma Tochigi, JP
Flight Dental Systems Usa Inc.
Houston, TX, US
Sycotec Gmbh & Co Kg
Leutkirch Baden-Wurttemberg, DE
Keystone Industries
Myerstown, PA, US
Vector Research & Development
UNIVERSITY PLACE, WA, US
Handpiece Headquarters
Placentia, CA, US
Swedent Dental Wholesale Group
Provo, UT, US
Satelec-acteon Group
MERIGNAC Gironde, FR
Saeshin Precision Co., Ltd.
Daegu, KR
Ttbio Corporation
TAICHUNG, TW
Sable Industries, Inc.
Kitchener Ontario, CA
Brasseler U.s.a. Dental, Llc
SAVANNAH, GA, US
Dental Technologies, Inc.
Lincolnwood, IL, US
Shofu Inc.
FUKUINE, HIGASHIYAMA-KU Kyoto, JP
Dci International, Llc
NEWBERG, OR, US
Nsk America Corp.
Hoffman Est, IL, US
Foshan Wenjian Medical Instrument Co., Ltd.
Foshan Guangdong, CN
Lares Research
CHICO, CA, US
W&h Dentalwerk Buermoos Gmbh
BUERMOOS Salzburg, AT
Beyes Dental Inc
Toronto Ontario, CA
510(k) clearances
261 clearances for this product code
- Foshan Topmed Dental Co., Ltd.Jan 12, 2026
K251389 · High speed air turbine handpiece
- Foshan Topmed Dental Co., Ltd.Jan 12, 2026
K251388 · 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)
- W&H Dentalwerk Bürmoos GmbHFeb 28, 2025
K242179 · Synea Fusion Handpieces (Intensiv & Profin)
- Guangdong Jinme Medical Technology Co., Ltd.Nov 13, 2024
K240337 · Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L)
- Foshan Soco Precision Instrument Co., Ltd.Nov 12, 2024
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)
- Nakanishi, Inc.Sep 20, 2024
K241880 · Air Powered Tooth Polishing System (Perio-Mate); Air Powered Tooth Polishing System (Perio Mate Nozzle Tip)
- Litu Tech , Ltd.Apr 30, 2024
K233122 · High Speed Air Turbine Handpiece (G100,G200,G300,G400,G450,G500,G600,G700,G700L,G800,G800L)
- Nakanishi, Inc.Apr 25, 2024
K233308 · Air Motor (Model name: FX204 M4); Air Motor (Model name: M205)