Handpiece, Rotary Bone Cutting
Dental · 21 CFR 872.4120
Recent MDR events
309 adverse event reports on file
- NSKJul 15, 2026InjuryNakanishi Inc.9611253-2026-00033
- NSKJul 15, 2026InjuryNakanishi Inc.9611253-2026-00034
- NSKJul 15, 2026InjuryNakanishi Inc.9611253-2026-00035
- NSKJul 15, 2026InjuryNakanishi Inc.9611253-2026-00036
- NSKJul 15, 2026InjuryNakanishi Inc.9611253-2026-00037
- NSKJul 15, 2026InjuryNakanishi Inc.9611253-2026-00038
- S-16Jul 14, 2026InjuryW&h Dentalwerk Buermoos Gmbh3003755849-2026-00003
- SGA-E2SJul 7, 2026InjuryNakanishi Inc.1422375-2026-00025
- SGS-E2SJul 7, 2026InjuryNakanishi Inc.1422375-2026-00027
- SGA-E2SJul 7, 2026InjuryNakanishi Inc.1422375-2026-00026
Event type breakdown
Recalls
10 recall events for this product code
- W&H DENTALWERK BUERMOOS GMBHOpen, ClassifiedFeb 20, 2024
W&H Surgical handpiece S-12. For Surgical treatment of dental hard tissue
1:2 speed increasing surgical handpieces have been incorrectly laser marked during production. The specific laser marking should read 1:2, but instead it reads 1:1 on the body of the handpiece
Z-1168-2024 · View FDA record ↗ - Nakanishi Inc.TerminatedOct 24, 2018
Surgical Handpiece, Model: SGS-E, Order Code: H084, Nakanishi Inc.
Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions of manual cleaning and specific parameters for autoclave sterilization . The previous operation manuals associated with the SGS/SGA products must be replaced by new operation manuals.
Z-0219-2019 · View FDA record ↗ - Nakanishi Inc.TerminatedOct 24, 2018
Surgical Handpiece, Model: SGS-E2G Order Code: H185, Nakanishi Inc.
Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions of manual cleaning and specific parameters for autoclave sterilization . The previous operation manuals associated with the SGS/SGA products must be replaced by new operation manuals.
Z-0220-2019 · View FDA record ↗ - Nakanishi Inc.TerminatedOct 24, 2018
Surgical Handpiece, Model: SGA-E Order Code: H083, Nakanishi Inc.
Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions of manual cleaning and specific parameters for autoclave sterilization . The previous operation manuals associated with the SGS/SGA products must be replaced by new operation manuals.
Z-0221-2019 · View FDA record ↗ - Nakanishi Inc.TerminatedOct 24, 2018
Surgical Handpiece, Model: SGA-E2G Order Code: H184, Nakanishi Inc.
Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions of manual cleaning and specific parameters for autoclave sterilization. The previous operation manuals associated with the SGS/SGA products must be replaced by new operation manuals.
Z-0222-2019 · View FDA record ↗ - Nakanishi Inc.TerminatedOct 24, 2018
Micro Surgery Handpiece SGS, Model: SGS-ES, Order Code: H264, Manufactured by: Nakanishi Inc.
Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions of manual cleaning and specific parameters for autoclave sterilization. The previous operation manuals associated with the SGS/SGA products must be replaced by new operation manuals.
Z-0223-2019 · View FDA record ↗ - Nakanishi Inc.TerminatedOct 24, 2018
Micro Surgery Handpiece SGS, Model: SGS-E2S, Order Code: H266, Manufactured by: Nakanishi Inc
Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions of manual cleaning and specific parameters for autoclave sterilization. The previous operation manuals associated with the SGS/SGA products must be replaced by new operation manuals.
Z-0224-2019 · View FDA record ↗ - Nakanishi Inc.TerminatedOct 24, 2018
Micro Surgery Handpiece SGA, Model SGA-ES, Order Code:H263, Manufactured by: Nakanishi Inc.
Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions of manual cleaning and specific parameters for autoclave sterilization. The previous operation manuals associated with the SGS/SGA products must be replaced by new operation manuals.
Z-0225-2019 · View FDA record ↗ - Nakanishi Inc.TerminatedOct 24, 2018
Micro Surgery Handpiece SGA, Model SGA-E2S Order Code:
Reprocessing instructions for the SGS/SGA Surgical Handpieces have been updated with instructions of manual cleaning and specific parameters for autoclave sterilization. The previous operation manuals associated with the SGS/SGA products must be replaced by new operation manuals.
Z-0226-2019 · View FDA record ↗ - Osteomed, LLCOpen, ClassifiedUnknown
OsteoMed OsteoPower Power Console:
Due to consoles not in compliance with the latest electrical safety standards IEC 60601 and as a result shocked a patient.
Z-0335-2022 · View FDA record ↗
Registered firms
26 firms currently registered for this product code
Nsk America Corp.
Hoffman Est, IL, US
W&h Dentalwerk Buermoos Gmbh
BUERMOOS Salzburg, AT
Nakanishi Inc.
Kanuma Tochigi, JP
Osteomed
ADDISON, TX, US
W&h Dentalwerk Buermoos Gmbh - Site 2
BUERMOOS Salzburg, AT
Dentsply Ih Bv
Sevenum Limburg, NL
Onvet Medical Canada Inc
TORONTO Ontario, CA
Foshan Coxo Medical Instrument Co., Ltd.
Foshan Guangdong, CN
Paltop Advanced Dental Solutions Ltd
Caesarea Central, IL
W&h Impex Inc.
Windsor Ontario, CA
Sweden & Martina Inc
Naperville, IL, US
Toyo Medical Co.
Doral, FL, US
Nobel Biocare Distribution Center Bv
Venlo Limburg, NL
Sterigenics Us Llc
Fort Worth, TX, US
Jmu Dental, Inc
Fullerton, CA, US
Hiossen Inc.
Norwood, NJ, US
510(k) clearances
9 clearances for this product code
- Nakanishi, Inc.Aug 19, 2021
K211584 · Oral Surgery Contra
- Nakanishi, Inc.Nov 21, 2017
K171155 · Surgical Angle Handpiece, Surgical Straight Handpiece
- OsteomedApr 4, 2017
K162544 · OsteoMed PINNACLE Driver
- W&H Dentalwerk Buermoos GmbHJul 29, 2008
K080939 · SURGICAL HANDPIECES, MIKRO SAW HANDPIECES
- Friadent GmbHFeb 18, 2000
K994298 · FRIOS MICROSAW
- Osteomed Corp.Jun 27, 1997
K971692 · OSTEOPOWER SYSTEM AND ACCESSORIES
- Nsk Nakanishi, Inc.Apr 15, 1997
K970953 · E-TYPE SPEED REDUCER CONTRA ANGLE
- Young Dental Manufacturing Co. 1, LLCApr 15, 1994
K932255 · YOUNG D'GRANULATOR