Handpiece, Belt And/or Gear Driven, Dental
Dental · 21 CFR 872.4200
Recent MDR events
220 adverse event reports on file
- T2 LINE A 200 LJul 20, 2026MalfunctionSirona Dental Systems Gmbh9614977-2026-00117
- T2 S-LINE AS 200 LJul 16, 2026MalfunctionSirona Dental Systems Gmbh9614977-2026-00110
- MASTERMATIC LUX M05 LJun 19, 2026MalfunctionKavo Dental Gmbh3003637274-2026-00026
- MASTERMATIC LUX M05 LJun 11, 2026MalfunctionKavo Dental Gmbh3003637274-2026-00022
- MASTERMATIC LUX M05 LJun 10, 2026MalfunctionKavo Dental Gmbh3003637274-2026-00023
- MASTERMATIC LUX M05 LMay 12, 2026MalfunctionKavo Dental Gmbh3003637274-2026-00016
- T2 LINE A 200 LApr 23, 2026MalfunctionSirona Dental Systems Gmbh9614977-2026-00015
- MASTERMATIC LUX M05 LApr 22, 2026MalfunctionKavo Dental Gmbh3003637274-2026-00014
- MASTERMATIC LUX M05 LApr 9, 2026MalfunctionKavo Dental Gmbh3003637274-2026-00011
- MASTERMATIC LUX M05 LJan 27, 2026MalfunctionKavo Dental Gmbh3003637274-2026-00002
Event type breakdown
Recalls
3 recall events for this product code
- Dental EZ Group Star Dental DivisionTerminatedJul 17, 2014
Titan T 5K Motor
The housing of 5K motor was laser marked incorrectly as a 20K motor. The recall was expanded in September 2014 to include additional lot #2251181.
Z-2078-2014 · View FDA record ↗ - Dental EZ Stardental DivisionTerminatedSep 2, 2010
Titan 3 5K Low-Speed Motor - Star Titan 3, 5,000 rpm- Lube Free
The housing of 5K motor is labeled as a 20K motor.
Z-2354-2010 · View FDA record ↗ - Stardental DivisionTerminatedDec 27, 2006
Solara Replacement Turbine, Autochuck End Cap, for dental handpiece, part number 064900.
End cap component can disassemble.
Z-0313-2007 · View FDA record ↗
Registered firms
24 firms currently registered for this product code
Anthogyr
SALLANCHES Haute-Savoie, FR
W&h Dentalwerk Buermoos Gmbh
BUERMOOS Salzburg, AT
Asi Medical, Inc.
ENGLEWOOD, CO, US
J. Morita Mfg. Corp., Tottori Factory
Kurayoshi Tottori, JP
Sirona Dental Systems Gmbh
BENSHEIM Hesse, DE
W&h Dentalwerk Buermoos Gmbh - Site 2
BUERMOOS Salzburg, AT
Kavo Dental Gmbh
WARTHAUSEN Baden-Wurttemberg, DE
Micro-nx Co., Ltd.
Dong-gu Daegu, KR
Isomedix Operations Inc.
SAN DIEGO, CA, US
A-dec, Inc.
Newberg, OR, US
Kerr Corporation
Pomona, CA, US
Dentsply Sirona Inc
York, PA, US
J. Morita Mfg. Corp.
FUSHIMI-KU Kyoto, JP
Dpm Usa Corp.
Doral, FL, US
Kerr Corporation
ORANGE, CA, US
Lares Research
CHICO, CA, US
Crosstex International
Rush, NY, US
Sanicure Bv
SCHIPHOL Noord-Holland, NL
Saeshin Precision Co., Ltd.
Daegu, KR
510(k) clearances
25 clearances for this product code
- Micro-Nx Co., Ltd.Aug 25, 2020
K192809 · Dental Handpiece
- Kaltenbach & Voigt GmbHMar 17, 2017
K163239 · SMARTmatic
- Kaltenbach & Voigt GmbHApr 9, 2015
K143465 · MASTERmatic LUX
- Redent Nova, Ltd.Jul 27, 2010
K101172 · RDT3 HANDPIECE HEAD MODEL RDT3
- AnthogyrMar 3, 2010
K093894 · ANTHOGYR IMPULSION IMPLANTOLOGY CONTRA-ANGLE
- Kaltenbach & Voigt GmbH & Co.Nov 3, 2009
K092446 · INTRA LUX HEAD 3 LDSY
- Dpm USA Corp.Oct 27, 2009
K090055 · LOW & HIGH SPEED KIT
- Saeshin Precision Co., Ltd.Sep 3, 2009
K092412 · STRONG IMPLANT HANDPIECES