FDA 510(k) Applications for Medical Device Product Code "EGS"
(Handpiece, Contra- And Right-Angle Attachment, Dental)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K220346 | AJK Engineering, Inc. | Lotus Prophy Angle | 11/07/2022 |
| K103157 | ANGSTROM MFG., INC. | DISPOSABLE PROPHY ANGLE; DISPOSABLE PROPHY ANGLE | 01/24/2011 |
| K103158 | ANGSTROM MFG., INC. | STRAIGHT HANDPIECE ADAPTER; CONTRA HANDPIECE ADAPTER; TWIST HANDPIECE ADAPTER; FLEX HANDPIECE ADAPTER | 02/07/2011 |
| K111532 | ANTHOGYR SAS | MONTBLANC SURGICAL CONTRA-ANGLE AND STRAIGHT HANDPIECE | 10/07/2011 |
| K020137 | ASEPTICO, INC. | AHP-66 4:1 REDUCTION CONTRANGLE: AHP-88 8:1 REDUCTION CONTRANGLE: AHP-88MP 8:1 REDUCTION CONTRANGLE - PUSH BUTTON | 03/04/2002 |
| K051077 | ASEPTICO, INC. | E-TYPE STRAIGHT HANDPIECE, MODEL AHP-101 | 05/03/2005 |
| K162856 | Bonart Co., Ltd. | Bonart Dental Handpieces (ART), Disposable Prophy Angle (PROFORMANCE) | 07/18/2017 |
| K060377 | DENTAL RESOURCES | DR DISPOSABLE PROPHY ANGLE MODEL H310 | 04/26/2006 |
| K983574 | DENTALEZ GROUP | STARDENTAL TITAN 3 LUBEFREE MOTOR ATTACHMENTS | 01/08/1999 |
| K162397 | DENTALEZ, INC | Titan 3 Low Speed Angle Attachments | 01/19/2017 |
| K133178 | DIRECTA AB | LUXATOR LX HANDPIECE | 11/24/2015 |
| K111541 | ESSENTIAL DENTAL SYSTEMS, INC. | ENDO-EXPRESS (R) HANDPIECE | 03/16/2012 |
| K060317 | EST. ANTHOGYR | ANTHOGYR CONTRA ANGLES AND HANDPIECES | 04/28/2006 |
| K092053 | HANDPIECE HEADQUARTERS | MAXIMA-M STRAIGHT ATTACHMENT, MAXIMA-M CONTRA ANGLE SHEATH | 08/20/2009 |
| K141125 | HANDPIECE HEADQUARTERS | U-TYPE CONTRA ANGLE, U-TYPE SECTIONAL CONTRA ANGLE | 10/23/2014 |
| K103697 | J. MORITA USA, INC. | TORQTECH | 01/20/2012 |
| K213139 | KaVo Dental GmbH | SURGmatic S15 L Pro | 12/21/2021 |
| K220874 | Lares Research | Smooth Drive contra angle and straight handpieces | 11/07/2022 |
| K042171 | MICRO-MEGA SOCIETE ANONYME | AX'S ENDO 04, 06, 08, 2.5, 40 , MODELS 50100206, 50100217, 50100218, 50100230, 50100232 | 11/10/2004 |
| K961494 | MICRO-MEGA SOCIETE ANONYME | SERIES XE 140XE,40XE,10XE/SERIES SE 140SE,40SE,10SE/SERIES 10TE | 06/26/1996 |
| K971350 | MICRO-MEGA SOCIETE ANONYME | SERIES XE, SERIES SE, SERIES TE | 06/04/1997 |
| K973800 | MIDWEST DENTAL PRODUCTS CORP. | 23:1 REDUCTION ANGLE | 03/11/1998 |
| K222518 | Nakanishi INC. | FX Contra | 11/17/2022 |
| K202960 | Nakanishi Inc. | General Cutting Contra Handpiece | 10/27/2020 |
| K182999 | Nakanishi Inc. | General Cutting Contra Handpiece | 04/16/2019 |
| K230106 | Nakanishi Inc. | General Cutting Straight | 05/24/2023 |
| K121901 | NAKANISHI, INC. | TI-MAX Z45 | 02/28/2013 |
| K022505 | NOUVAG AG | CONTRA-ANGLE, MODELS 1059, 5050, 5051, 5055, 5056, 5057, 5059, 5060, 5061, 5062, 5063, 5064, 5065, 5066, 5067, 5068, | 10/01/2003 |
| K962540 | NSK NAKANISHI, INC. | E-TYPE CONTRA ANGLE NAC-E | 09/12/1996 |
| K972569 | NSK NAKANISHI, INC. | E-TYPE SPEED INCREASER CONTRA ANGLE, EXTERNAL IRRIGATION, INTERNAL IRRIGATION | 10/08/1997 |
| K061897 | ORTHOSOURCE, INC. | EXCEL CONTRA ANGLE HANDPIECE | 02/14/2007 |
| K030603 | PAC-DENT INTERNATIONAL (SUZHOU), LTD. | PROANGLE DISPOSABLE PROPHY ANGLE | 04/14/2003 |
| K100854 | PREMIUM PLUS INTERNATIONAL LIMITED | PREMIUM PLUS DISPOSABLE PROPHY ANGLE MODEL 3399 | 12/09/2010 |
| K032925 | RONVIG A/S | B&R DEVICE | 12/22/2003 |
| K100192 | SAESHIN PRECISION CO., LTD. | STRONG DENTAL HANDPIECES | 02/04/2010 |
| K171436 | Saeshin Precision Co., Ltd. | STRONG Dental Handpieces | 01/05/2018 |
| K181129 | Saeshin Precision Co., Ltd. | STRONG Dental Handpieces | 01/31/2019 |
| K143418 | Saeshin Precision Co., Ltd. | STRONG Dental Handpieces | 07/31/2015 |
| K182892 | Saeshin Precision Co., Ltd. | TRAUS Dental Handpieces | 11/26/2019 |
| K132356 | SCICAN GMBH | SANAO 200L, SANAO 40 /SANAO 40L, SANAO 10L, SANAO PSI / SANAO PSO, SANAO 40ST | 01/31/2014 |
| K150750 | Sirona Dental Systems GMBH | Endo 6:1, T1 Line Endo 6 L, SIRONiTi Apex, T1 Spray | 07/02/2015 |
| K023953 | ST. GEORGE TECHNOLOGY, INC. | ST. GEORGE TECHNOLOGY, INC PERFECTION PLUS DISPOSABLE PROPHY ANGLE | 02/14/2003 |
| K022264 | SVENSKA DENTAL INSTRUMENTS AB | CLEAN 'N' OIL | 10/02/2002 |
| K994024 | TEAM TECHNOLOGIES, INC. | EXTENDED STRAIGHT ATTACHMENT | 02/03/2000 |
| K112305 | THUNDER TIGER CORP. | VIGOR A LOW SPEED AIR MOTOR, VIGOR C LOW SPEED CONTRA-ANGLE HANDPIECES, VIGOR S LOW SPEED STRAIGHT HANDPIECES | 04/17/2012 |
| K011061 | W & H DENTALWERK BUERMOOS GMBH | SURGICAL CONTRA-ANGEL HANDPIECES TYPES WS-56E,WS-75E/KM,WS-92 E/3,SURGICAL STRAIGHT HANDPIECES TYPES, S-9, S-10, S-11 | 06/28/2001 |
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