Handpiece, Contra- And Right-angle Attachment, Dental
Dental · 21 CFR 872.4200
Recent MDR events
2,629 adverse event reports on file
- Lares ResearchJul 30, 2026InjuryLares Research2916440-2026-00006
- X-SMART PLUS VERSION 0202Jul 22, 2026MalfunctionMaillefer Instruments Holding Sarl8031010-2026-00109
- NSKJul 17, 2026InjuryNakanishi Inc.9611253-2026-00039
- MASTERMATIC LUX M25 LJul 14, 2026InjuryKavo Dental Gmbh1017522-2026-00001
- VDW.GOLD RECIPROCJun 29, 2026MalfunctionVdw Gmbh9611053-2026-00205
- VDW.GOLD RECIPROCJun 26, 2026MalfunctionVdw Gmbh9611053-2026-00204
- MASTERMATIC LUX M25 LJun 25, 2026MalfunctionKavo Dental Gmbh3003637274-2026-00028
- VDW.GOLD RECIPROCJun 25, 2026MalfunctionVdw Gmbh9611053-2026-00202
- X-SMART PLUSJun 24, 2026MalfunctionMaillefer Instruments Holding Sarl8031010-2026-00081
- X-SMART PLUSJun 24, 2026MalfunctionMaillefer Instruments Holding Sarl8031010-2026-00085
Event type breakdown
Recalls
2 recall events for this product code
- Young Dental Manufacturing I, LLCOpen, ClassifiedNov 9, 2023
CONTRA GRAY (soft) TURBO PLUS CUPS, REF 153112. Dental Prophylaxis Angles
one lot of Contra Gray (soft) Turbo Plus Cups Dental Prophylaxis Angles may contain Contra Petite Web LF Soft Purple Cup DPAs.
Z-0285-2024 · View FDA record ↗ - Bien Air Dental SATerminatedSep 21, 2015
Contra-Angles CA1:1L EVO 15
Possible loosening of the dental tool, which may lead to potential swallowing of the tool.
Z-2797-2015 · View FDA record ↗
Registered firms
165 firms currently registered for this product code
Oketz Logistics Llc
Coral Gables, FL, US
Patterson Dental Supply, Inc.
ST. PAUL, MN, US
Sweden & Martina Inc
Naperville, IL, US
Flight Dental Systems Usa Inc.
Houston, TX, US
Nakanishi Inc.
Kanuma Tochigi, JP
Saeshin Precision Co., Ltd.
Daegu, KR
Brasseler U.s.a. Dental, Llc
SAVANNAH, GA, US
Nsk America Corp.
Hoffman Est, IL, US
Foshan Wenjian Medical Instrument Co., Ltd.
Foshan Guangdong, CN
Cordica Medical, Inc. (formally Team Technologies, Inc.)
MORRISTOWN, TN, US
Lares Research
CHICO, CA, US
Jmu Dental, Inc
Fullerton, CA, US
Beyes Dental Inc
Toronto Ontario, CA
Worldwide Supplies Limited
Hong Kong, HK
Foshan Soco Precision Instrument Co.,ltd.
Foshan Guangdong, CN
Amd Medicom Inc.
Pointe-Claire, Montreal Quebec, CA
Dentalez, Inc., Stardental Division
Lancaster, PA, US
Angstrom Mfg., Inc.
Sainte Genevieve, MO, US
Boone Center, Incorporated
Moscow Mills, MO, US
Solventum Us Llc
San Antonio, TX, US
Dentsply Sirona Inc
York, PA, US
510(k) clearances
73 clearances for this product code
- Premium Plus (Dongguan) LimitedSep 15, 2025
K251869 · Disposable Prophy Angle (3399-60, 3399-090, 3399-105)
- Pacific Care LimitedMay 28, 2025
K240950 · Disposable Prophy Angle
- Dentalez, Inc., Stardental DivisionSep 19, 2024
K240183 · Star E900 Handpiece Series
- Nakanishi, Inc.May 24, 2023
K230106 · General Cutting Straight
- Nakanishi, Inc.Nov 17, 2022
K222518 · FX Contra
- Lares ResearchNov 7, 2022
K220874 · Smooth Drive contra angle and straight handpieces
- Ajk Engineering, Inc.Nov 7, 2022
K220346 · Lotus Prophy Angle
- Micro-Nx Co., Ltd.Jul 29, 2022
K220577 · Dental Handpiece, Model CA160, CA160L, and CA500L