Product Code: EGS FDA class 1 21 CFR 872.4200

Handpiece, Contra- And Right-Angle Attachment, Dental

Dental

The Contra- and Right-Angle Attachment Handpiece is a dental instrument attachment that connects to the main handpiece motor and redirects the rotational drive at an angle, allowing access to posterior teeth and difficult-to-reach areas of the oral cavity. It is classified as FDA Class 1 (lowest risk), subject only to general controls, and does not require premarket notification. The product code is EGS, regulated under 21 CFR 872.4200 in the Dental (DE) specialty. This device is eligible for third-party review.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

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Basic Information

Product Code: EGS
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 73 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K251869	Disposable Prophy Angle (3399-60, 3399-090, 3399-105)	Sep 15, 2025	Substantially Equivalent	Premium Plus (Dongguan) Limited
K240950	Disposable Prophy Angle	May 28, 2025	Substantially Equivalent	Pacific Care Limited
K240183	Star E900 Handpiece Series	Sep 19, 2024	Substantially Equivalent	Dentalez, Inc., Stardental Division
K230106	General Cutting Straight	May 24, 2023	Substantially Equivalent	Nakanishi, Inc.
K222518	FX Contra	Nov 17, 2022	Substantially Equivalent	Nakanishi, Inc.
K220874	Smooth Drive contra angle and straight handpieces	Nov 07, 2022	Substantially Equivalent	Lares Research
K220346	Lotus Prophy Angle	Nov 07, 2022	Substantially Equivalent	Ajk Engineering, Inc.
K220577	Dental Handpiece, Model CA160, CA160L, and CA500L	Jul 29, 2022	Substantially Equivalent	Micro-Nx Co., Ltd.
K213139	SURGmatic S15 L Pro	Dec 21, 2021	Substantially Equivalent	Kavo Dental GmbH
K202960	General Cutting Contra Handpiece	Oct 27, 2020	Substantially Equivalent	Nakanishi, Inc.
K182892	TRAUS Dental Handpieces	Nov 26, 2019	Substantially Equivalent	Saeshin Precision Co., Ltd.
K182999	General Cutting Contra Handpiece	Apr 16, 2019	Substantially Equivalent	Nakanishi, Inc.
K181129	STRONG Dental Handpieces	Jan 31, 2019	Substantially Equivalent	Saeshin Precision Co., Ltd.
K171436	STRONG Dental Handpieces	Jan 05, 2018	Substantially Equivalent	Saeshin Precision Co., Ltd.
K162856	Bonart Dental Handpieces (ART), Disposable Prophy Angle (PROFORMANCE)	Jul 18, 2017	Substantially Equivalent	Bonart Co., Ltd.
K162397	Titan 3 Low Speed Angle Attachments	Jan 19, 2017	Substantially Equivalent	Dentalez, Inc.
K133178	LUXATOR LX HANDPIECE	Nov 24, 2015	Substantially Equivalent	Directa AB
K143418	STRONG Dental Handpieces	Jul 31, 2015	Substantially Equivalent	Saeshin Precision Co., Ltd.
K150750	Endo 6:1, T1 Line Endo 6 L, SIRONiTi Apex, T1 Spray	Jul 02, 2015	Substantially Equivalent	Sirona Dental Systems GmbH
K141125	U-TYPE CONTRA ANGLE, U-TYPE SECTIONAL CONTRA ANGLE	Oct 23, 2014	Substantially Equivalent	Handpiece Headquarters
K132356	SANAO 200L, SANAO 40 /SANAO 40L, SANAO 10L, SANAO PSI / SANAO PSO, SANAO 40ST	Jan 31, 2014	Substantially Equivalent	Scican GmbH
K121901	TI-MAX Z45	Feb 28, 2013	Substantially Equivalent	Nakanishi, Inc.
K112305	VIGOR A LOW SPEED AIR MOTOR, VIGOR C LOW SPEED CONTRA-ANGLE HANDPIECES, VIGOR S LOW SPEED STRAIGHT HANDPIECES	Apr 17, 2012	Substantially Equivalent	Thunder Tiger Corp.
K111541	ENDO-EXPRESS (R) HANDPIECE	Mar 16, 2012	Substantially Equivalent	Essential Dental Systems, Inc.
K103697	TORQTECH	Jan 20, 2012	Substantially Equivalent	J. Morita USA, Inc.
K111532	MONTBLANC SURGICAL CONTRA-ANGLE AND STRAIGHT HANDPIECE	Oct 07, 2011	Substantially Equivalent	Anthogyr Sas
K103158	STRAIGHT HANDPIECE ADAPTER; CONTRA HANDPIECE ADAPTER; TWIST HANDPIECE ADAPTER; FLEX HANDPIECE ADAPTER	Feb 07, 2011	Substantially Equivalent	Angstrom Mfg., Inc.
K103157	DISPOSABLE PROPHY ANGLE; DISPOSABLE PROPHY ANGLE	Jan 24, 2011	Substantially Equivalent	Angstrom Mfg., Inc.
K100854	PREMIUM PLUS DISPOSABLE PROPHY ANGLE MODEL 3399	Dec 09, 2010	Substantially Equivalent	Premium Plus International Limited
K100192	STRONG DENTAL HANDPIECES	Feb 04, 2010	Substantially Equivalent	Saeshin Precision Co., Ltd.
K092053	MAXIMA-M STRAIGHT ATTACHMENT, MAXIMA-M CONTRA ANGLE SHEATH	Aug 20, 2009	Substantially Equivalent	Handpiece Headquarters
K061897	EXCEL CONTRA ANGLE HANDPIECE	Feb 14, 2007	Substantially Equivalent	Orthosource, Inc.
K060317	ANTHOGYR CONTRA ANGLES AND HANDPIECES	Apr 28, 2006	Substantially Equivalent	Est. Anthogyr
K060377	DR DISPOSABLE PROPHY ANGLE MODEL H310	Apr 26, 2006	Substantially Equivalent	Dental Resources
K051077	E-TYPE STRAIGHT HANDPIECE, MODEL AHP-101	May 03, 2005	Substantially Equivalent	Aseptico, Inc.
K042171	AX'S ENDO 04, 06, 08, 2.5, 40 , MODELS 50100206, 50100217, 50100218, 50100230, 50100232	Nov 10, 2004	Substantially Equivalent	Micro-Mega Societe Anonyme
K032925	B&R DEVICE	Dec 22, 2003	Substantially Equivalent	Ronvig A/S
K022505	CONTRA-ANGLE, MODELS 1059, 5050, 5051, 5055, 5056, 5057, 5059, 5060, 5061, 5062, 5063, 5064, 5065, 5066, 5067, 5068,	Oct 01, 2003	Substantially Equivalent	NOUVAG AG
K030603	PROANGLE DISPOSABLE PROPHY ANGLE	Apr 14, 2003	Substantially Equivalent	Pac-Dent International (Suzhou), Ltd.
K023953	ST. GEORGE TECHNOLOGY, INC PERFECTION PLUS DISPOSABLE PROPHY ANGLE	Feb 14, 2003	Substantially Equivalent	St. George Technology, Inc.
K022264	CLEAN 'N' OIL	Oct 02, 2002	Substantially Equivalent	Svenska Dental Instruments AB
K020137	AHP-66 4:1 REDUCTION CONTRANGLE: AHP-88 8:1 REDUCTION CONTRANGLE: AHP-88MP 8:1 REDUCTION CONTRANGLE - PUSH BUTTON	Mar 04, 2002	Substantially Equivalent	Aseptico, Inc.
K011061	SURGICAL CONTRA-ANGEL HANDPIECES TYPES WS-56E,WS-75E/KM,WS-92 E/3,SURGICAL STRAIGHT HANDPIECES TYPES, S-9, S-10, S-11	Jun 28, 2001	Substantially Equivalent	W&H Dentalwerk Buermoos GmbH
K994024	EXTENDED STRAIGHT ATTACHMENT	Feb 03, 2000	Substantially Equivalent	Team Technologies, Inc.
K983574	STARDENTAL TITAN 3 LUBEFREE MOTOR ATTACHMENTS	Jan 08, 1999	Substantially Equivalent	Dentalez Group
K973800	23:1 REDUCTION ANGLE	Mar 11, 1998	Substantially Equivalent	Midwest Dental Products Corp.
K972569	E-TYPE SPEED INCREASER CONTRA ANGLE, EXTERNAL IRRIGATION, INTERNAL IRRIGATION	Oct 08, 1997	Substantially Equivalent	Nsk Nakanishi, Inc.
K971350	SERIES XE, SERIES SE, SERIES TE	Jun 04, 1997	Substantially Equivalent	Micro-Mega Societe Anonyme
K962540	E-TYPE CONTRA ANGLE NAC-E	Sep 12, 1996	Substantially Equivalent	Nsk Nakanishi, Inc.
K961494	SERIES XE 140XE,40XE,10XE/SERIES SE 140SE,40SE,10SE/SERIES 10TE	Jun 26, 1996	Substantially Equivalent	Micro-Mega Societe Anonyme
K950555	J SINGLE USE HEAD AND JD REUSABLE HANDLE	Dec 28, 1995	Substantially Equivalent	Micro-Mega Societe Anonyme
K954802	RITE-ANGLE DISPOSABLE PROPHY ANGLES	Nov 08, 1995	Substantially Equivalent	Ash-USA
K950773	PROPHYLAXIS PACK	Mar 31, 1995	Unknown	Transidyne General Corp.
K950743	ORAL PROCEDURE PACK	Mar 31, 1995	Unknown	Transidyne General Corp.
K945834	PROPHY PRO.	Feb 13, 1995	Substantially Equivalent	Hyman, Phelps & McNamara, P.C.
K942480	M4 CONTRA-ANGLE HANDPIECE	Jan 27, 1995	Substantially Equivalent	Kerr Corporation (Danbury)
K933639	IMKB CONTRA-ANGLES	Sep 21, 1994	Substantially Equivalent	Micro-Mega
K934781	BVR HIGH TORQUE HEADS	Aug 05, 1994	Substantially Equivalent	Bvr Aero Precision Corp.
K934571	BVR CONTRA-ANGLE HANDPIECE	Aug 01, 1994	Substantially Equivalent	Bvr Aero Precision Corp.
K941009	DISPOSABLE PROPHY ANGLE	Jun 06, 1994	Substantially Equivalent	Allpro, Inc.
K941189	DISPOSABLE PROPHYLAXIS ANGLE	May 16, 1994	Substantially Equivalent	Team Technologies, Inc.
K923980	Q3 DISPOSABLE PROPHY ANGLE	May 27, 1993	Substantially Equivalent	Q3 Special Products, Inc.
K850294	CANAL FINDER	Jun 04, 1985	Substantially Equivalent	Roseburg SA
K844989	FLO-PHORESIS - DESENSITIZER	Apr 01, 1985	Substantially Equivalent	Eastco, Inc.
K850344	AM-40 POWER OPTIC AIR MOTOR POWER OPTIC CONTRA ANG	Mar 25, 1985	Substantially Equivalent	Midwest
K821686	DENSCO PROPHY ANGLE	Jun 25, 1982	Substantially Equivalent	Teledyne Densco
K801688	TORX HANDPIECE CONTRA ANGLES ATTACHMENTS	Aug 04, 1980	Substantially Equivalent	Pacific Dental Corp.
K800735	U-STYLE ADAPTER	Apr 10, 1980	Substantially Equivalent	American Midwest
K792445	MW STRAIGHT ATTACHMENT	Dec 06, 1979	Substantially Equivalent	Midwest
K790722	PROPHYLAXIS ANGLE	Jun 15, 1979	Substantially Equivalent	Young Dental Manufacturing Co. 1, LLC
K780752	PROPHYLAXIS ANGLE	May 26, 1978	Substantially Equivalent	Young Dental Manufacturing Co. 1, LLC
K780213	HANDPIECE, LIFT, ENDO	Feb 17, 1978	Substantially Equivalent	Kerr Corporation (Danbury)
K780199	PROPHY ANGLES, R&R	Feb 16, 1978	Substantially Equivalent	Ransom and Randolph