Controller, Foot, Handpiece And Cord
Dental · 21 CFR 872.4200
Recent MDR events
392 adverse event reports on file
- UNK PREVJun 19, 2026MalfunctionDentsply Llc2424472-2026-00809
- VDW.SILVER RECIPROCMay 4, 2026MalfunctionVdw Gmbh9611053-2026-00131
- VDW.SILVER RECIPROCApr 7, 2026MalfunctionVdw Gmbh9611053-2026-00109
- E3KIT REPAIR - E3KITMar 9, 2026MalfunctionTulsa Dental Products Llc2320721-2026-00022
- VDW.SILVER RECIPROCFeb 25, 2026MalfunctionVdw Gmbh9611053-2026-00058
- VDW.SILVER RECIPROCFeb 12, 2026MalfunctionVdw Gmbh9611053-2026-00043
- VDW.SILVER RECIPROCFeb 10, 2026MalfunctionVdw Gmbh9611053-2026-00042
- VDW.SILVER RECIPROCJan 12, 2026MalfunctionVdw Gmbh9611053-2026-00007
- VDW.SILVER RECIPROCJan 12, 2026MalfunctionVdw Gmbh9611053-2026-00008
- ELECTROMATIC M/CDec 17, 2025MalfunctionKavo Dental Gmbh3003637274-2025-00022
Event type breakdown
Recalls
2 recall events for this product code
- Nobel Biocare Usa LlcTerminatedNov 13, 2013
Osseocare Pro Console & Set Osseocare Pro, Model 1600870-001, 1700470-001, and 1700471-001.
The recall was initiated because there is a potential for malfunction of the OsseoCare Pro when used with the OseeoCare Pro iPad application software release 1.2.0.7.
Z-0273-2014 · View FDA record ↗ - W & H DentalWerk Burmoos GMBH - Site 1TerminatedUnknown
Foot Controls
During continuous postmarket surveillance activities, we have noticed a potential malfunction of individual foot controls of the type S-N1/S-N2. In case the error occurs, the foot control might not switch back to zero position when the pedal is released. Consequently, the motor keeps rotating. If this happens during automatic thread cutting or automatic screwing-in of implants, it may, in the worst case, lead to a serious injury of the patient.
Z-1351-2018 · View FDA record ↗
Registered firms
147 firms currently registered for this product code
Nsk America Corp.
Hoffman Est, IL, US
Nakanishi Inc.
Kanuma Tochigi, JP
W&h Dentalwerk Buermoos Gmbh - Site 2
BUERMOOS Salzburg, AT
Vector Research & Development
UNIVERSITY PLACE, WA, US
Guangxi Ehall Medical Technology Co.,ltd
Nanning Guangxi, CN
W&h Impex Inc.
Windsor Ontario, CA
Jmu Dental, Inc
Fullerton, CA, US
W&h Dentalwerk Buermoos Gmbh
BUERMOOS Salzburg, AT
Kavo Dental Gmbh
WARTHAUSEN Baden-Wurttemberg, DE
Transmedic Healthcare Sdn Bhd
Kuala Lumpur Kuala Lumpur, MY
Oketz Logistics Llc
Coral Gables, FL, US
Sanko Electronics Corporation
Midori Gunma, JP
Dentsply Sirona Inc
York, PA, US
Adin Dental Implant Systems Ltd.
Afula Northern, IL
Toyo Medical Co.
Doral, FL, US
Guilin Woodpecker Medical Instrument Co., Ltd
GUILIN CITY Guangxi, CN
Force Engineering Co.ltd
Utsunomiya Tochigi, JP
Sycotec Gmbh & Co Kg
Leutkirch Baden-Wurttemberg, DE
Arthrex Manufacturing Inc.
Pendleton, SC, US
510(k) clearances
61 clearances for this product code
- Saeshin Precision Co., Ltd.Jan 30, 2026
K251407 · Motor Handpiece and Control Unit (SDI10)
- Dentalez, Inc., Stardental DivisionJan 12, 2026
K251701 · Star E900 Electric System
- Dentsply Sirona, Inc.Aug 25, 2025
K251811 · Motor and Apex Module (MaAM)
- Micro-Nx Co., Ltd.Jul 18, 2025
K231562 · ELEC ENGINE (Model: ISE-170L)
- Guilin Aesthedent Medical Instruments Co., Ltd.Apr 11, 2025
K242646 · Dental Implant Unit
- Nakanishi, Inc.Jun 24, 2024
K233288 · NLZ Built-In Motor System
- Nakanishi, Inc.Jun 20, 2024
K233117 · Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON-OPT)
- Cefla S.C.Apr 1, 2024
K230895 · CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMr L FLUO, i-MMs, i-MMs FLUO; i-XR3, i-XR3 L, i-XR3 L FLUO, i-XS4,