Dental Device Guide
Add your company

Surgical devices · 21 CFR 872 Subpart E

Dental Belt and/or Gear Driven Handpiece

FDA device type “Handpiece, Belt And/Or Gear Driven, Dental”.

FDA codeEFAClass121 CFR872.4200Pathway510(k)CategoryDental handpieces
Companies listing it
159 makers
Brands and models
49
510(k) clearances
250 in five years
FDA name
Handpiece, Belt And/Or Gear Driven, Dental
1980: 11987: 11996: 41997: 42000: 12001: 12004: 12006: 22007: 12009: 42010: 22015: 12017: 12020: 119801990200020102020

510(k) clearances per year, 1976–2026

Companies that list EFA

15 companies currently list this device type with FDA.

CompanyCountryRoleBrands and models listedClearancesLatest
Institut Straumann AGSwitzerlandMakerCONTRE-ANGLES · HAND-PIECES · IMPULSION CONTRA-ANGLES · MONT BLANC IMPLANTOLOGY · +12122026
Dentsply Sirona, Inc.United StatesMaker—1482026
MICRO-NX Co., Ltd.South KoreaMakerELEC, Dental Handpiece (Model: CA100L) · ELEC, Dental Handpiece (Model: CA100R) · ELEC, Dental Handpiece (Model: SA100L) · ELEC, Dental Handpiece (Model: SA100R) · +272025
Saeshin Precision Co., Ltd.South KoreaMakerSTRONG IMPLANT HANDPIECES162026
W&H Dentalwerk Buermoos GmbHAustriaMaker—172026
KaVo Dental GmbHGermanyMakerelements 8:1 - 111.6786 · SMARTmatic ENDO S321 - 111.6790 · SMARTmatic ENDO S81 - 111.6780 · SMARTmatic PROPHY S19 - 111.6740 · +1922021
Asi Medical, Inc.United StatesMakerAdvanced Dental System · Advanced Endodontic System · Triton Dental System52013
Dpm USA Corp.United StatesMakerTubinetta Fit Lux, Tubinetta Ultra, Switch E, Bogotta Light Plus, Bogota Stilla Prime22009
J. Morita MFG Corp.JapanMakerARETE · HIGH SPEED AIR TURBINE HANDPIECES, PAR-4HEX/4HX SERIES (TWINPOWER TURBINE 4H) · Midwest 45 · STERLING · +1——
Sybron Dental SpecialtiesUnited StatesContract manufacturerelements 8:1 Dental Handpiece2032026
Lares ResearchUnited StatesManufacturerPastel Prophy Angle, disposable82022
A-dec, Inc.United StatesManufacturerAir Low Speed Handpiece · Electric Low Speed Handpiece682022
STERIS CorporationUnited StatesContract sterilizer———
SPS/Crosstex InternationalUnited StatesManufacturerTWIST RECIPROCATING D——
Sanicure BVNetherlandsForeign exporter———

510(k) clearances

Decided510(k)DeviceApplicant
25 Aug 2020K192809Dental HandpieceMICRO-NX Co., Ltd.
17 Mar 2017K163239SMARTmaticKaltenbach & Voigt GmbH
9 Apr 2015K143465MASTERmatic LUXKaltenbach & Voigt GmbH
27 Jul 2010K101172RDT3 HANDPIECE HEAD MODEL RDT3Redent Nova, Ltd.
3 Mar 2010K093894ANTHOGYR IMPULSION IMPLANTOLOGY CONTRA-ANGLEInstitut Straumann AG
3 Nov 2009K092446INTRA LUX HEAD 3 LDSYKaltenbach & Voigt GmbH & Co.
27 Oct 2009K090055LOW & HIGH SPEED KITDpm USA Corp.
3 Sep 2009K092412STRONG IMPLANT HANDPIECESSaeshin Precision Co., Ltd.
22 May 2009K090676MONTBLANC IMPLANTOLOGY AND OMNIPRATIQUE CONTRA-ANGLESInstitut Straumann AG
8 Mar 2007K070084MONTBLANC IMPLANTOLOGY CONTRA ANGLE CONTROLEst. Anthogyr
25 Aug 2006K061701HIGH SPEED AIR TURBINE HANDPIECES, PAR-4HEX/4HX SERIES (TWIN POWER TURBINE 4H)J. Morita USA, Inc.
16 Aug 2006K061581EXCEL HIGH SPEED DENTAL HANDPIECEOrtho Source
30 Jun 2004K040674IMPLANTOLOGY CONTRA ANGLES, ENDODONTIC CONTRA ANGLES, GENERAL DENTISTRY CONTRA ANGLESInstitut Straumann AG
28 Nov 2001K013185TCM ENDO IIINouvag AG
17 Nov 2000K002709RACE ENDODONTIC FILEAmc General, Inc.
9 Oct 1997K973062TWIST RECIPROCATING DISPOSABLE PROPHY ANGLEMedidenta Intl., Inc.
4 Jun 1997K971603STERILE SUREFLEX FILES AND INSTRUMENTSDentsply Intl., Inc.
3 Jun 1997K971606STERILE FLEXOFILE FILES AND INSTRUMENTSDentsply Intl., Inc.
19 Mar 1997K965238T1 CONTROL HIGH SPEED DENTAL HANDPIECESiemens AG
28 Mar 1996K960719STAR DENTAL 430 SERIES HIGH SPEED HANDPIECEDentalez Group
28 Mar 1996K960507STAR DENTAL PUSHBUTTON AUTOCHUCK REPLACEMENT TURBINE FOR MIDWEST HANDPIECESDentalez Group
28 Mar 1996K960260STAR TITAN SERIES MOTORS & ATTACHMENTSDentalez Group
20 Mar 1996K953865SPACELINE FEEL 21J. Morita USA, Inc.
14 Oct 1987K873147USI DENTAL POLISHER. A/G-20Cranston Ind., Inc.
5 Feb 1980K800163VIMEDIC SYSTEM TMMedical Systems Group of Viskay, Inc.

Official records: FDA product classification for EFA · 21 CFR 872.4200.

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026