EGS · Handpiece, Contra- And Right-Angle Attachment, Dental
Dental · 21 CFR 872.4200 · Class 1
Overview
| Product Code | EGS |
|---|---|
| Device Name | Handpiece, Contra- And Right-Angle Attachment, Dental |
| Regulation | 21 CFR 872.4200 |
| Device Class | Class 1 |
| Review Panel | Dental |
| 3rd-Party Reviewable | Yes |
Identification
A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.
Classification Rationale
Class I.
Cleared Devices (73)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K251869 | Disposable Prophy Angle (3399-60, 3399-090, 3399-105) | Premium Plus (Dongguan) Limited | Sep 15, 2025 | SESE |
| K240950 | Disposable Prophy Angle | Pacific Care Limited | May 28, 2025 | SESE |
| K240183 | Star E900 Handpiece Series | Dentalez, Inc., Stardental Division | Sep 19, 2024 | SESE |
| K230106 | General Cutting Straight | Nakanishi, Inc. | May 24, 2023 | SESE |
| K222518 | FX Contra | Nakanishi, Inc. | Nov 17, 2022 | SESE |
| K220874 | Smooth Drive contra angle and straight handpieces | Lares Research | Nov 7, 2022 | SESE |
| K220346 | Lotus Prophy Angle | Ajk Engineering, Inc. | Nov 7, 2022 | SESE |
| K220577 | Dental Handpiece, Model CA160, CA160L, and CA500L | Micro-Nx Co., Ltd. | Jul 29, 2022 | SESE |
| K213139 | SURGmatic S15 L Pro | Kavo Dental GmbH | Dec 21, 2021 | SESE |
| K202960 | General Cutting Contra Handpiece | Nakanishi, Inc. | Oct 27, 2020 | SESE |
| K182892 | TRAUS Dental Handpieces | Saeshin Precision Co., Ltd. | Nov 26, 2019 | SESE |
| K182999 | General Cutting Contra Handpiece | Nakanishi, Inc. | Apr 16, 2019 | SESE |
| K181129 | STRONG Dental Handpieces | Saeshin Precision Co., Ltd. | Jan 31, 2019 | SESE |
| K171436 | STRONG Dental Handpieces | Saeshin Precision Co., Ltd. | Jan 5, 2018 | SESE |
| K162856 | Bonart Dental Handpieces (ART), Disposable Prophy Angle (PROFORMANCE) | Bonart Co., Ltd. | Jul 18, 2017 | SESE |
| K162397 | Titan 3 Low Speed Angle Attachments | Dentalez, Inc. | Jan 19, 2017 | SESE |
| K133178 | LUXATOR LX HANDPIECE | Directa AB | Nov 24, 2015 | SESE |
| K143418 | STRONG Dental Handpieces | Saeshin Precision Co., Ltd. | Jul 31, 2015 | SESE |
| K150750 | Endo 6:1, T1 Line Endo 6 L, SIRONiTi Apex, T1 Spray | Sirona Dental Systems GmbH | Jul 2, 2015 | SESE |
| K141125 | U-TYPE CONTRA ANGLE, U-TYPE SECTIONAL CONTRA ANGLE | Handpiece Headquarters | Oct 23, 2014 | SESE |
| K132356 | SANAO 200L, SANAO 40 /SANAO 40L, SANAO 10L, SANAO PSI / SANAO PSO, SANAO 40ST | Scican GmbH | Jan 31, 2014 | SESE |
| K121901 | TI-MAX Z45 | Nakanishi, Inc. | Feb 28, 2013 | SESE |
| K112305 | VIGOR A LOW SPEED AIR MOTOR, VIGOR C LOW SPEED CONTRA-ANGLE HANDPIECES, VIGOR S LOW SPEED STRAIGHT HANDPIECES | Thunder Tiger Corp. | Apr 17, 2012 | SESE |
| K111541 | ENDO-EXPRESS (R) HANDPIECE | Essential Dental Systems, Inc. | Mar 16, 2012 | SESE |
| K103697 | TORQTECH | J. Morita USA, Inc. | Jan 20, 2012 | SESE |
| K111532 | MONTBLANC SURGICAL CONTRA-ANGLE AND STRAIGHT HANDPIECE | Anthogyr Sas | Oct 7, 2011 | SESE |
| K103158 | STRAIGHT HANDPIECE ADAPTER; CONTRA HANDPIECE ADAPTER; TWIST HANDPIECE ADAPTER; FLEX HANDPIECE ADAPTER | Angstrom Mfg., Inc. | Feb 7, 2011 | SESE |
| K103157 | DISPOSABLE PROPHY ANGLE; DISPOSABLE PROPHY ANGLE | Angstrom Mfg., Inc. | Jan 24, 2011 | SESE |
| K100854 | PREMIUM PLUS DISPOSABLE PROPHY ANGLE MODEL 3399 | Premium Plus International Limited | Dec 9, 2010 | SESE |
| K100192 | STRONG DENTAL HANDPIECES | Saeshin Precision Co., Ltd. | Feb 4, 2010 | SESE |
| K092053 | MAXIMA-M STRAIGHT ATTACHMENT, MAXIMA-M CONTRA ANGLE SHEATH | Handpiece Headquarters | Aug 20, 2009 | SESE |
| K061897 | EXCEL CONTRA ANGLE HANDPIECE | Orthosource, Inc. | Feb 14, 2007 | SESE |
| K060317 | ANTHOGYR CONTRA ANGLES AND HANDPIECES | Est. Anthogyr | Apr 28, 2006 | SESE |
| K060377 | DR DISPOSABLE PROPHY ANGLE MODEL H310 | Dental Resources | Apr 26, 2006 | SESE |
| K051077 | E-TYPE STRAIGHT HANDPIECE, MODEL AHP-101 | Aseptico, Inc. | May 3, 2005 | SESE |
| K042171 | AX'S ENDO 04, 06, 08, 2.5, 40 , MODELS 50100206, 50100217, 50100218, 50100230, 50100232 | Micro-Mega Societe Anonyme | Nov 10, 2004 | SESE |
| K032925 | B&R DEVICE | Ronvig A/S | Dec 22, 2003 | SESE |
| K022505 | CONTRA-ANGLE, MODELS 1059, 5050, 5051, 5055, 5056, 5057, 5059, 5060, 5061, 5062, 5063, 5064, 5065, 5066, 5067, 5068, | NOUVAG AG | Oct 1, 2003 | SESE |
| K030603 | PROANGLE DISPOSABLE PROPHY ANGLE | Pac-Dent International (Suzhou), Ltd. | Apr 14, 2003 | SESE |
| K023953 | ST. GEORGE TECHNOLOGY, INC PERFECTION PLUS DISPOSABLE PROPHY ANGLE | St. George Technology, Inc. | Feb 14, 2003 | SESE |
| K022264 | CLEAN 'N' OIL | Svenska Dental Instruments AB | Oct 2, 2002 | SESE |
| K020137 | AHP-66 4:1 REDUCTION CONTRANGLE: AHP-88 8:1 REDUCTION CONTRANGLE: AHP-88MP 8:1 REDUCTION CONTRANGLE - PUSH BUTTON | Aseptico, Inc. | Mar 4, 2002 | SESE |
| 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 | W&H Dentalwerk Buermoos GmbH | Jun 28, 2001 | SESE |
| K994024 | EXTENDED STRAIGHT ATTACHMENT | Team Technologies, Inc. | Feb 3, 2000 | SESE |
| K983574 | STARDENTAL TITAN 3 LUBEFREE MOTOR ATTACHMENTS | Dentalez Group | Jan 8, 1999 | SESE |
| K973800 | 23:1 REDUCTION ANGLE | Midwest Dental Products Corp. | Mar 11, 1998 | SESE |
| K972569 | E-TYPE SPEED INCREASER CONTRA ANGLE, EXTERNAL IRRIGATION, INTERNAL IRRIGATION | Nsk Nakanishi, Inc. | Oct 8, 1997 | SESE |
| K971350 | SERIES XE, SERIES SE, SERIES TE | Micro-Mega Societe Anonyme | Jun 4, 1997 | SESE |
| K962540 | E-TYPE CONTRA ANGLE NAC-E | Nsk Nakanishi, Inc. | Sep 12, 1996 | SESE |
| K961494 | SERIES XE 140XE,40XE,10XE/SERIES SE 140SE,40SE,10SE/SERIES 10TE | Micro-Mega Societe Anonyme | Jun 26, 1996 | SESE |
| K950555 | J SINGLE USE HEAD AND JD REUSABLE HANDLE | Micro-Mega Societe Anonyme | Dec 28, 1995 | SESE |
| K954802 | RITE-ANGLE DISPOSABLE PROPHY ANGLES | Ash-USA | Nov 8, 1995 | SESE |
| K950773 | PROPHYLAXIS PACK | Transidyne General Corp. | Mar 31, 1995 | SESK |
| K950743 | ORAL PROCEDURE PACK | Transidyne General Corp. | Mar 31, 1995 | SESK |
| K945834 | PROPHY PRO. | Hyman, Phelps & McNamara, P.C. | Feb 13, 1995 | SESE |
| K942480 | M4 CONTRA-ANGLE HANDPIECE | Kerr Corporation (Danbury) | Jan 27, 1995 | SESE |
| K933639 | IMKB CONTRA-ANGLES | Micro-Mega | Sep 21, 1994 | SESE |
| K934781 | BVR HIGH TORQUE HEADS | Bvr Aero Precision Corp. | Aug 5, 1994 | SESE |
| K934571 | BVR CONTRA-ANGLE HANDPIECE | Bvr Aero Precision Corp. | Aug 1, 1994 | SESE |
| K941009 | DISPOSABLE PROPHY ANGLE | Allpro, Inc. | Jun 6, 1994 | SESE |
| K941189 | DISPOSABLE PROPHYLAXIS ANGLE | Team Technologies, Inc. | May 16, 1994 | SESE |
| K923980 | Q3 DISPOSABLE PROPHY ANGLE | Q3 Special Products, Inc. | May 27, 1993 | SESE |
| K850294 | CANAL FINDER | Roseburg SA | Jun 4, 1985 | SESE |
| K844989 | FLO-PHORESIS - DESENSITIZER | Eastco, Inc. | Apr 1, 1985 | SESE |
| K850344 | AM-40 POWER OPTIC AIR MOTOR POWER OPTIC CONTRA ANG | Midwest | Mar 25, 1985 | SESE |
| K821686 | DENSCO PROPHY ANGLE | Teledyne Densco | Jun 25, 1982 | SESE |
| K801688 | TORX HANDPIECE CONTRA ANGLES ATTACHMENTS | Pacific Dental Corp. | Aug 4, 1980 | SESE |
| K800735 | U-STYLE ADAPTER | American Midwest | Apr 10, 1980 | SESE |
| K792445 | MW STRAIGHT ATTACHMENT | Midwest | Dec 6, 1979 | SESE |
| K790722 | PROPHYLAXIS ANGLE | Young Dental Manufacturing Co. 1, LLC | Jun 15, 1979 | SESE |
| K780752 | PROPHYLAXIS ANGLE | Young Dental Manufacturing Co. 1, LLC | May 26, 1978 | SESE |
| K780213 | HANDPIECE, LIFT, ENDO | Kerr Corporation (Danbury) | Feb 17, 1978 | SESE |
| K780199 | PROPHY ANGLES, R&R | Ransom and Randolph | Feb 16, 1978 | SESE |
Top Applicants
- Saeshin Precision Co., Ltd. — 5 clearances
- Nakanishi, Inc. — 5 clearances
- Micro-Mega Societe Anonyme — 4 clearances
- Young Dental Manufacturing Co. 1, LLC — 2 clearances
- Transidyne General Corp. — 2 clearances
