Product Code: EFA FDA class 1 21 CFR 872.4200

Handpiece, Belt And/Or Gear Driven, Dental

Dental

The Belt and/or Gear Driven Dental Handpiece is a dental device that transmits rotational power to dental burs and other rotary instruments via an internal belt or gear mechanism, used for cutting, grinding, and polishing teeth and restorative materials. It is classified as FDA Class 1, the lowest risk category, subject only to general controls and no premarket submission is required. The product code is EFA and the applicable regulation is 21 CFR 872.4200, under the Dental medical specialty. This device is eligible for third-party 510(k) review.

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510(k)s

FEI Numbers

Registration Numbers

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Basic Information

Product Code: EFA
Device Class: FDA class 1
Regulation Number: 872.4200
Medical Specialty: Dental
Review Panel: DE
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 25 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K192809	Dental Handpiece	Aug 25, 2020	Substantially Equivalent	Micro-Nx Co., Ltd.
K163239	SMARTmatic	Mar 17, 2017	Substantially Equivalent	Kaltenbach & Voigt GmbH
K143465	MASTERmatic LUX	Apr 09, 2015	Substantially Equivalent	Kaltenbach & Voigt GmbH
K101172	RDT3 HANDPIECE HEAD MODEL RDT3	Jul 27, 2010	Substantially Equivalent	Redent Nova, Ltd.
K093894	ANTHOGYR IMPULSION IMPLANTOLOGY CONTRA-ANGLE	Mar 03, 2010	Substantially Equivalent	Anthogyr
K092446	INTRA LUX HEAD 3 LDSY	Nov 03, 2009	Substantially Equivalent	Kaltenbach & Voigt GmbH & Co.
K090055	LOW & HIGH SPEED KIT	Oct 27, 2009	Substantially Equivalent	Dpm USA Corp.
K092412	STRONG IMPLANT HANDPIECES	Sep 03, 2009	Substantially Equivalent	Saeshin Precision Co., Ltd.
K090676	MONTBLANC IMPLANTOLOGY AND OMNIPRATIQUE CONTRA-ANGLES	May 22, 2009	Substantially Equivalent	Anthogyr
K070084	MONTBLANC IMPLANTOLOGY CONTRA ANGLE CONTROL	Mar 08, 2007	Substantially Equivalent	Est. Anthogyr
K061701	HIGH SPEED AIR TURBINE HANDPIECES, PAR-4HEX/4HX SERIES (TWIN POWER TURBINE 4H)	Aug 25, 2006	Substantially Equivalent	J. Morita USA, Inc.
K061581	EXCEL HIGH SPEED DENTAL HANDPIECE	Aug 16, 2006	Substantially Equivalent	Orthosource, Inc.
K040674	IMPLANTOLOGY CONTRA ANGLES, ENDODONTIC CONTRA ANGLES, GENERAL DENTISTRY CONTRA ANGLES	Jun 30, 2004	Substantially Equivalent	Anthogyr
K013185	TCM ENDO III	Nov 28, 2001	Substantially Equivalent	NOUVAG AG
K002709	RACE ENDODONTIC FILE	Nov 17, 2000	Substantially Equivalent	Amc General, Inc.
K973062	TWIST RECIPROCATING DISPOSABLE PROPHY ANGLE	Oct 09, 1997	Substantially Equivalent	Medidenta Intl., Inc.
K971603	STERILE SUREFLEX FILES AND INSTRUMENTS	Jun 04, 1997	Substantially Equivalent	Dentsply Intl.
K971606	STERILE FLEXOFILE FILES AND INSTRUMENTS	Jun 03, 1997	Substantially Equivalent	Dentsply Intl.
K965238	T1 CONTROL HIGH SPEED DENTAL HANDPIECE	Mar 19, 1997	Substantially Equivalent	Siemens AG
K960719	STAR DENTAL 430 SERIES HIGH SPEED HANDPIECE	Mar 28, 1996	Substantially Equivalent	Dentalez Group
K960507	STAR DENTAL PUSHBUTTON AUTOCHUCK REPLACEMENT TURBINE FOR MIDWEST HANDPIECES	Mar 28, 1996	Substantially Equivalent	Dentalez Group
K960260	STAR TITAN SERIES MOTORS & ATTACHMENTS	Mar 28, 1996	Substantially Equivalent	Dentalez Group
K953865	SPACELINE FEEL 21	Mar 20, 1996	Substantially Equivalent	J. Morita USA, Inc.
K873147	USI DENTAL POLISHER. A/G-20	Oct 14, 1987	Substantially Equivalent	Cranston Ind., Inc.
K800163	VIMEDIC SYSTEM TM	Feb 05, 1980	Substantially Equivalent	Medical Systems Group of Viskay, Inc.