Handpiece, Direct Drive, Ac-powered
Dental · 21 CFR 872.4200
Recent MDR events
736 adverse event reports on file
- X-Smart Pro+Jul 28, 2026MalfunctionSirona Dental Systems Gmbh9614977-2026-00122
- VDW.GOLD RECIPROCJul 27, 2026MalfunctionVdw Gmbh9611053-2026-01186
- X-Smart Pro / X-Smart Pro+Jul 27, 2026MalfunctionSirona Dental Systems Gmbh9614977-2026-00121
- X-SMART PLUSJul 27, 2026MalfunctionMaillefer Instruments Holding S.a.r.l.8031010-2026-00579
- PROMARK MOTOR REPLACEMENTJul 21, 2026MalfunctionTulsa Dental Products Llc2320721-2026-00081
- X-SMART PRO+Jul 17, 2026MalfunctionSirona Dental Systems Gmbh9614977-2026-00115
- X-SMART W/CONTRA ANGLE EURJul 1, 2026MalfunctionMaillefer Instruments Holding Sarl8031010-2026-00096
- PROMARK MOTOR REPLACEMENTMay 19, 2026MalfunctionTulsa Dental Products Llc2320721-2026-00061
- PROMARK ENDO MOTORMar 31, 2026MalfunctionTulsa Dental Products Llc2320721-2026-00031
- PROMARK ENDO MOTORMar 19, 2026MalfunctionTulsa Dental Products Llc2320721-2026-00025
Event type breakdown
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
138 firms currently registered for this product code
Changzhou Bomedent Medical Technology Co., Ltd
Changzhou Jiangsu, CN
W&h Dentalwerk Buermoos Gmbh - Site 2
BUERMOOS Salzburg, AT
Riverside Medical Packaging Company Ltd
Derby Derbyshire, GB
Ads Dental System Inc.
Ontario, CA, US
Forum Engineering Technologies (96) Ltd.
Ashkelon Southern, IL
Imagine Milling Technologies, Llc
Milford, NH, US
Sanko Electronics Corporation
Midori Gunma, JP
Kerr Corporation
ORANGE, CA, US
Integration Diagnostics Sweden Ab
Goteborg Vastra Gotaland, SE
Foshan Cicada Dental Instrument Co., Ltd.
Foshan Guangdong, CN
Nsk America Corp.
Hoffman Est, IL, US
Ultradent Products Inc.
South Jordan, UT, US
Jmu Dental, Inc
Fullerton, CA, US
Changzhou Sifary Medical Technology Co., Ltd.
Changzhou Jiangsu, CN
Nakanishi Inc.
Kanuma Tochigi, JP
Kavo Dental Gmbh
WARTHAUSEN Baden-Wurttemberg, DE
Sic Invent Ag
Basel Town Basel-Landschaft, CH
Bicon, Llc
Boston, MA, US
Aseptico, Inc.
WOODINVILLE, WA, US
Satelec-acteon Group
MERIGNAC Gironde, FR
Gebr. Brasseler Gmbh & Co. Kg
LEMGO North Rhine-Westphalia, DE
510(k) clearances
89 clearances for this product code
- SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.Oct 16, 2025
K252223 · Alpha Endo Handpiece (Alpha Endo)
- Perimetrics, Inc.Sep 18, 2025
K251597 · InnerView System
- Advanced Technology Research (A.T.R.) S.R.L.Aug 22, 2025
K243692 · EnDrive (EnDriveUS)
- Shenzhen Rogin Medical Co., Ltd.Apr 24, 2025
K242514 · Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO)
- Dentis Co., Ltd.Mar 21, 2025
K241065 · ChecQ (AC100)
- Handpiece HeadquartersDec 20, 2024
K243911 · HPR Cordless Hygiene Handpiece
- Genoss Co., Ltd.Aug 9, 2024
K222688 · The Trust
- Dentsply Sirona, Inc.Jul 24, 2024
K233865 · X-Smart Pro; X-Smart Pro+