Surgical devices · 21 CFR 872 Subpart E
Dental Contra- and Right-Angle Attachment Handpiece
FDA device type “Handpiece, Contra- And Right-Angle Attachment, Dental”.
- Companies listing it
- 8044 makers
- Brands and models
- 452
- 510(k) clearances
- 739 in five years
- FDA name
- Handpiece, Contra- And Right-Angle Attachment, Dental
510(k) clearances per year, 1976–2026
Companies that list EGS
80 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Institut Straumann AG | Switzerland | Maker | SURGERY MONTBLANC CONTRA-ANGLE · SURGERY MONTBLANC HANDPIECE | 212 | 2026 |
| Dentsply Sirona, Inc. | United States | Maker | Contra Angle Heads · Midwest Handpiece, · Midwest RDH · NUPRO revolv · +3 | 148 | 2026 |
| Nakanishi, Inc. | Japan | Maker | ARK-2 · ARS-1 · BB-EC · E-TYPE CONTRA ANGLE NAC-E · +145 | 37 | 2026 |
| Nobel Biocare Services AG | Switzerland | Maker | Handpiece S-11, straight 1:1 | 94 | 2026 |
| Guilin Woodpecker Medical Instrument Co., Ltd. | China | Maker | Contra-angle handpiece: WJ-15, WJ-15L, WJ-45T, WJ-45TL · Contra-angle handpiece: WJ-45L · Dental Electric Motor · ES5, ES5+, ES5 Pro, ES5 Pro+ · +2 | 12 | 2025 |
| Foshan COXO Medical Instrument Co., Ltd. | China | Maker | Air Motors; CX235-3B, CX235-3C, CX235-3F · Dental Electrical Motors; C-PUMA MASTER · Dental Implantation Systems; C-Sailor Pro · Geared Angle Handpieces; CX235-1B, CX235-1C, CX235-1F, CX235-1G, CX235C1, CX235C2, CX235C3 · +4 | 6 | 2025 |
| MICRO-NX Co., Ltd. | South Korea | Maker | ELEC, Dental Handpiece (Model: CA160) · ELEC, Dental Handpiece (Model: CA160L) · ELEC, Dental Handpiece (Model: CA500L) | 7 | 2025 |
| Young Innovations Inc | United States | Maker | Johnson Promident · Latch Type and Straight Handpiece · Mandrel · Prophylaxis Angles · +1 | 23 | 2025 |
| Saeshin Precision Co., Ltd. | South Korea | Maker | ACL(B)-61I, ACL(B)-62I, ACL(B)-63I, ACL(B)-65I, ACL(B)-04C · AHP-85-SS · DENTIS DIP20 · MEARA; MEAHP · +4 | 16 | 2026 |
| Guangdong JINME Medical Technology Co., Ltd. | China | Maker | Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L) · Dental Low-Speed Turbine Handpiece (Model: LN, L) | 5 | 2026 |
| Dentalez, Inc. | United States | Maker | ETorque Handpieces - 265471, 265472, 265473, 265474, 265475 · Star E900 1:1 Auto Latch, Fiber Optic Handpiece - 266343 · Star E900 1:1 Straight, Handpiece - 266345 · Star E900 1:5 Auto Chuck, Fiber Optic Handpiece - 266342 · +17 | 9 | 2026 |
| Lares Research | United States | Maker | Perfect Finish 1:1 Contra Angle with push button latch head · Perfect Finish 4:1 Contra Angle with push button latch head · Perfect Finish 4:1 Contra Angle with screw-in type prophy head · Perfect Finish 4:1 Contra Angle with snap-on type prophy head · +2 | 8 | 2022 |
| Handpiece Headquarters | United States | Maker | Ball Bearing Latch Contra Angle 40K · Deluxe Sectional Ball Bearing Latch Contra Angle 40K · Deluxe Sectional Friction Grip Contra Angle 20K · Deluxe Sectional Latch Contra Angle 20K · +2 | 7 | 2024 |
| Ttbio Corp. | Taiwan | Maker | QualityPlus HME001, QualityPlus HST001-1:1, QualityPlus HST001-4:1, QualityPlus HC001, QualityPlus HC001L · Vigor C35, Vigor C2000, Vigor C100, Vigor C25, Vigor C20, Vigor A65, Vigor A68, Vigor S15, Vigor S18 · Vigor S100P, ADVANCED DENTAL, Vigor A67, Choice Pro, A65, S15, C35 | 6 | 2023 |
| Pac-Dent Inc. | United States | Maker | ACCLEAN ERGO PROPHY ANGLE LF · AntiSplatr Disposable Prophy Angles · AntiSplatr Flex Ergo Slim Disposable Prophy Angle Bulk Pack, Contra Angle, Flex Cup, 1,200ct · AntiSplatr Flex Ergo Slim Disposable Prophy Angle, Contra Angle, Flex Cup, 200ct · +8 | 5 | 2022 |
| Premium Plus (Dongguan) Limited | China | Maker | Disposable Prophy Angles | 2 | 2025 |
| Foshan Topmed Dental Co., Ltd. | China | Maker | Dental air-motor handpiece(TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS, TM-ES, TM-SG20, TM-X25, TM-BB, TM-IC, TM-RA41) | 2 | 2026 |
| W&H Dentalwerk Buermoos GmbH | Austria | Maker | — | 17 | 2026 |
| Essential Dental Systems, Inc. | United States | Maker | Endo-Express | 15 | 2023 |
| Codent Technical Industry Co., Ltd. | Taiwan | Maker | CODENT LOW SPEED DENTAL HANDPIECES AND ACCESSORIES | 5 | 2024 |
| KaVo Dental GmbH | Germany | Maker | 114.4000 - SURGmatic S15 L Pro | 2 | 2021 |
| Foshan SOCO Precision Instrument Co.,Ltd. | China | Maker | Air Motors: SCHD16-M, SCHD17-M, SCHD24-M, SCHD27-M) · Dental Low Speed Handpieces including Straight and Geared Angle Handpieces and Air Motors Straight Handpieces: SCHD24-S · Dental Low Speed Handpieces including Straight and Geared Angle Handpieces and Air Motors Straight Handpieces:SCHD17-S · Dental Low Speed Handpieces including Straight and Geared Angle Handpieces and Air Motors Straight Handpiecess:SCHD16-S · +14 | 1 | 2024 |
| Pacific Care Limited | Hong Kong SAR China | Maker | Disposable Prophy Angle | 1 | 2025 |
| Bonart Co., Ltd. | Taiwan | Maker | Bonart (ART) Dental Handpieces, Disposable Prophy Angle (PROFORMANCE) & Accessories | 14 | 2017 |
| CNC Manufacturing, Inc. | United States | Maker | Lynx Contra Sheath | 5 | 2007 |
| Nouvag AG | Switzerland | Maker | Clip for external cooling · Clip for internal cooling · Contra angle · Handpiece · +1 | 4 | 2008 |
| Premium Plus International Limited | Hong Kong SAR China | Maker | Atomo Dental Disposable Prophy Angle · Dentmas · PREMIUM PLUS DISPOSABLE PROPHY ANGLE MODEL 3399 | 3 | 2017 |
| Preventive Technologies, Inc. | United States | Maker | ESA EXTENDED STRAIGHT | 3 | 2014 |
| Sable Industries, Inc. | Canada | Maker | FDA Product Code EFB: Electronic fiber optic control board · FDA Product Code EFB: Premium Slow Speed 20K Air Motors w/ Internal Air & Water · FDA Product Code EFB: Premium Slow Speed Straight Nosecones 1:1 Ball Bearing w/ Internal Air & Water · FDA Product Code EFB: Sable EX-203 Type 22K 4-Hole Air Motors · +19 | 2 | 2009 |
| MicroP Technology (Taiwan), Inc. | Taiwan | Maker | Dental Handpieces and Accessories HALLEY Series | 2 | 2021 |
| Angstrom Mfg., Inc. | United States | Maker | Prophy Angle | 2 | 2011 |
| Nakamura Dental Handpiece Mfg. Co., Ltd. | Japan | Maker | ACCLEAN · CONTRA ANGLE · HyGenie · ND · +5 | 1 | 2012 |
| Foshan Wenjian Medical Instrument Co., Ltd. | China | Maker | High-speed air turbine handpiece (model: WJ-114, WJ- 112, WJ-124, WJ -122, WJ- 134, WJ -132, WJ - 144) · High-speed air turbine handpiece (model: WJ-142, WJ-154, WJ-152, WJ-164, WJ-162) · Low-speed air turbine handpiece (WJ-414, WJ-412, WJ-424, WJ-422) | 1 | 2020 |
| SPS/Crosstex International | United States | Maker | Sparkle EZ Contra Angle · Sparkle Prophy Angle · Twist Plus | — | — |
| Dentatus AB | Sweden | Maker | Profin/EVA · Profinet | — | — |
| Beyes Dental Inc | Canada | Maker | Beyes Dental Maxso Lowspeed handpiece · Electric Handpiece System: E600P; E800P; E800B; X99L | — | — |
| Solventum US LLC | United States | Maker | — | — | — |
| J. Morita MFG Corp. | Japan | Maker | TORQTECH | — | — |
| AMD Medicom Inc | Canada | Maker | Medicom Prophy Angle · Prophy Angle | — | — |
| Onvet Medical Canada Inc. | Canada | Maker | AMW AirPeak G100, G200, G200X;G300, G400,MT05;MT20; P100; AMW iTesla G500, G600, G700, G800,MT40 · iTesla Dental Implant System | — | — |
| SycoTec GmbH & Co KG | Germany | Maker | ETorque Handpieces · Midwest E Attachments · SANAO 10L/10 · SANAO 200L · +4 | — | — |
| Cordica Medical (Formally Team Technologies, Inc) | United States | Maker | — | — | — |
| Tani Electronics Corporation | Japan | Maker | FC-78 · Surgic Pro NON-OPT(120V) · Surgic Pro OPT(120V) · Surgic Pro OPT(230V) · +1 | — | — |
| Proguard Health Inc. | United States | Maker | — | — | — |
| Prismatik Dentalcraft, Inc. | United States | Contract manufacturer | — | 56 | 2026 |
| Hiossen Inc. | United States | Manufacturer | SM3 | 26 | 2026 |
| Sybron Dental Specialties | United States | Contract manufacturer | M4 Handpiece · PerfectPearl Disposable Prophy Angle · PetitePearl Disposable Prophy Angle | 203 | 2026 |
| Paltop Advanced Dental Solutions Inc. | United States | Contract manufacturer | Contra Angle NSK | 7 | 2025 |
| Park Dental Research Corp | United States | Contract manufacturer | — | 8 | 2026 |
| Keystone Industries | United States | Contract manufacturer | Fortis Disposable Prophy Angles · Keystone Disposable Prophy Angles · Nero Disposable Prophy Angles | 2 | 2025 |
| A-dec, Inc. | United States | Manufacturer | Midwest Endo Lit Handpiece | 68 | 2022 |
| DCI International LLC | United States | Manufacturer | Assy, Nsk Display, S5 Dr · Kit, Motor, Electric, NSK NLZ E, Mobile DR, Left · Kit, Motor, Electric, NSK NLZ E, Mobile DR, Right · Kit, Motor, Electric, NSK NLZ E, Series 4, Left · +29 | 1 | 2025 |
| Setagaya Seiki Co., Ltd. | Japan | Foreign exporter | — | 1 | 2026 |
| Bicon, LLC | United States | Manufacturer | Impulsion · WI-75 E/KM | 18 | 2015 |
| Aseptico, Inc. | United States | Contract manufacturer | AHP-09 - ASEPTISPRAY HPCE LUBRICANT WITH E TYPE NOZZLE ADAPTER · AHP-101 - HPCE 1:1 STRT LOW SPEED DORIOT · AHP-11 - ONESTEP LUBRICANT WITH E TYPE NOZZLE ADAPTER · AHP-50 - MOTOR AIR 20K RPM 4H · +35 | 17 | 2015 |
| Integra LifeSciences Corporation | United States | Contract manufacturer | Miltex · Padgett · Tardie | 2 | 2014 |
| Osseo Scientific, LLC | United States | Repacker / relabeler | Contra Angles and Dental Heads | 1 | 2007 |
| Sweden & Martina INC | United States | Lister | IMPLANT ANGLE HANDPIECE · MICRONITI ROTARY ENDOHANDPIECE | — | — |
| Jmu Dental, Inc. | United States | Repacker / relabeler | COXO Handpiece, X TITAN Handpiece · Dental Electric Motor · Dental Electric Motor / Dental Implantation System | — | — |
| Patterson Companies, Inc. | United States | Foreign exporter | Handpiece, air-powered, dental · Patterson Handpiece · Patterson® 1:1 Contra Angle · Patterson® 1:1 Nosecone · +1 | — | — |
| Nordent MFG., Inc. | United States | Contract manufacturer | MT-2 | — | — |
| GoldenDent | United States | Repacker / relabeler | Dental Electric Motor, MT2, MT3, Controller Foot, Handpience and Cord, Contra and Right Angle attachment | — | — |
| Flight Dental Systems USA Inc. | United States | Repacker / relabeler | Bold Series Highspeed Handpiece - F-160K · Bold Series Highspeed Handpiece - F-170K, F-160, F-164, F-164T, F-170KT, QC-164K, QC-170, F-140, F-161K, F-162K, F-163K · F-416BM, F-414BSU, F-434BSUW, F-424BZ, F-L80HEAD, F-L68HEAD · F-424BM, F-424BW, F-415BZ, FFB-Y-HEAD, FFB-HEAD, FFB-HEAD, F-541CA, F-411CA, F-DE11, F-DE01, F-DE41, F-DE41PS, F-DE74 · +1 | — | — |
| CARGUS International Inc. | United States | Repacker / relabeler | — | — | — |
| Jiangsu Yabaobao Medical Instrument Co.,Ltd. | China | Foreign exporter | — | — | — |
| Maxill Inc. | United States | Foreign exporter | Maxill | — | — |
| Ads Dental System Inc. | United States | Remanufacturer | Contra-angle handpiece: WJ-45L, WJ-45TL;Dental Electric Motor:MT2,M2 Pro | — | — |
| Toyo Medical Co. | United States | Repacker / relabeler | Nakanishi Inc | — | — |
| ATOMO Dental, Inc. | United States | Repacker / relabeler | PROPHY ANGLE | — | — |
| Henry Schein MSO, LLC | United States | Repacker / relabeler | W&H | — | — |
| W&H Impex Inc. | Canada | Foreign exporter | — | — | — |
| Sanicure BV | Netherlands | Foreign exporter | Handpiece, contra- and right-angle attachment, dental | — | — |
| Zapalign LLC | United States | Repacker / relabeler | Handpiece, contra- and right-angle attachment, dental | — | — |
| Peter Brasseler Holdings, LLC | United States | Contract manufacturer | Brasseler Electric Motor · Brasseler Forza Attachments · Forza + | — | — |
| Head Dental Corp. | United States | Repacker / relabeler | Handpiece, air-powered, dental | — | — |
| Nouvatec LLC | United States | Repacker / relabeler | Nouvag AG | — | — |
| Boone Center, Inc. | United States | Repacker / relabeler | — | — | — |
| Mainline Medical Dental Supply | Canada | Foreign exporter | — | — | — |
| Oketz Logistics LLC | United States | Repacker / relabeler | — | — | — |
| Worldwide Supplies Limited | Hong Kong SAR China | Foreign exporter | — | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 15 Sep 2025 | K251869 | Disposable Prophy Angle (3399-60, 3399-090, 3399-105) | Premium Plus (Dongguan) Limited |
| 28 May 2025 | K240950 | Disposable Prophy Angle | Pacific Care Limited |
| 19 Sep 2024 | K240183 | Star E900 Handpiece Series | Dentalez, Inc. |
| 24 May 2023 | K230106 | General Cutting Straight | Nakanishi, Inc. |
| 17 Nov 2022 | K222518 | FX Contra | Nakanishi, Inc. |
| 7 Nov 2022 | K220874 | Smooth Drive contra angle and straight handpieces | Lares Research |
| 7 Nov 2022 | K220346 | Lotus Prophy Angle | Ajk Engineering, Inc. |
| 29 Jul 2022 | K220577 | Dental Handpiece, Model CA160, CA160L, and CA500L | MICRO-NX Co., Ltd. |
| 21 Dec 2021 | K213139 | SURGmatic S15 L Pro | KaVo Dental GmbH |
| 27 Oct 2020 | K202960 | General Cutting Contra Handpiece | Nakanishi, Inc. |
| 26 Nov 2019 | K182892 | TRAUS Dental Handpieces | Saeshin Precision Co., Ltd. |
| 16 Apr 2019 | K182999 | General Cutting Contra Handpiece | Nakanishi, Inc. |
| 31 Jan 2019 | K181129 | STRONG Dental Handpieces | Saeshin Precision Co., Ltd. |
| 5 Jan 2018 | K171436 | STRONG Dental Handpieces | Saeshin Precision Co., Ltd. |
| 18 Jul 2017 | K162856 | Bonart Dental Handpieces (ART), Disposable Prophy Angle (PROFORMANCE) | Bonart Co., Ltd. |
| 19 Jan 2017 | K162397 | Titan 3 Low Speed Angle Attachments | Dentalez, Inc. |
| 24 Nov 2015 | K133178 | LUXATOR LX HANDPIECE | Directa AB |
| 31 Jul 2015 | K143418 | STRONG Dental Handpieces | Saeshin Precision Co., Ltd. |
| 2 Jul 2015 | K150750 | Endo 6:1, T1 Line Endo 6 L, SIRONiTi Apex, T1 Spray | Dentsply Sirona, Inc. |
| 23 Oct 2014 | K141125 | U-TYPE CONTRA ANGLE, U-TYPE SECTIONAL CONTRA ANGLE | Handpiece Headquarters |
| 31 Jan 2014 | K132356 | SANAO 200L, SANAO 40 /SANAO 40L, SANAO 10L, SANAO PSI / SANAO PSO, SANAO 40ST | Coltene/Whaledent AG |
| 28 Feb 2013 | K121901 | TI-MAX Z45 | Nakanishi, Inc. |
| 17 Apr 2012 | K112305 | VIGOR A LOW SPEED AIR MOTOR, VIGOR C LOW SPEED CONTRA-ANGLE HANDPIECES, VIGOR S LOW SPEED STRAIGHT HANDPIECES | Thunder Tiger Corp. |
| 16 Mar 2012 | K111541 | ENDO-EXPRESS (R) HANDPIECE | Essential Dental Systems, Inc. |
| 20 Jan 2012 | K103697 | TORQTECH | J. Morita USA, Inc. |
| 7 Oct 2011 | K111532 | MONTBLANC SURGICAL CONTRA-ANGLE AND STRAIGHT HANDPIECE | Institut Straumann AG |
| 7 Feb 2011 | K103158 | STRAIGHT HANDPIECE ADAPTER; CONTRA HANDPIECE ADAPTER; TWIST HANDPIECE ADAPTER; FLEX HANDPIECE ADAPTER | Angstrom Mfg., Inc. |
| 24 Jan 2011 | K103157 | DISPOSABLE PROPHY ANGLE; DISPOSABLE PROPHY ANGLE | Angstrom Mfg., Inc. |
| 9 Dec 2010 | K100854 | PREMIUM PLUS DISPOSABLE PROPHY ANGLE MODEL 3399 | Premium Plus International Limited |
| 4 Feb 2010 | K100192 | STRONG DENTAL HANDPIECES | Saeshin Precision Co., Ltd. |
| 20 Aug 2009 | K092053 | MAXIMA-M STRAIGHT ATTACHMENT, MAXIMA-M CONTRA ANGLE SHEATH | Handpiece Headquarters |
| 14 Feb 2007 | K061897 | EXCEL CONTRA ANGLE HANDPIECE | Ortho Source |
| 28 Apr 2006 | K060317 | ANTHOGYR CONTRA ANGLES AND HANDPIECES | Est. Anthogyr |
| 26 Apr 2006 | K060377 | DR DISPOSABLE PROPHY ANGLE MODEL H310 | Dental Resources |
| 3 May 2005 | K051077 | E-TYPE STRAIGHT HANDPIECE, MODEL AHP-101 | Aseptico, Inc. |
| 10 Nov 2004 | K042171 | AX'S ENDO 04, 06, 08, 2.5, 40 , MODELS 50100206, 50100217, 50100218, 50100230, 50100232 | Micro-Mega Societe Anonyme |
| 22 Dec 2003 | K032925 | B&R DEVICE | Ronvig A/S |
| 1 Oct 2003 | K022505 | CONTRA-ANGLE, MODELS 1059, 5050, 5051, 5055, 5056, 5057, 5059, 5060, 5061, 5062, 5063, 5064, 5065, 5066, 5067, 5068, | Nouvag AG |
| 14 Apr 2003 | K030603 | PROANGLE DISPOSABLE PROPHY ANGLE | Pac-Dent International (Suzhou), Ltd. |
| 14 Feb 2003 | K023953 | ST. GEORGE TECHNOLOGY, INC PERFECTION PLUS DISPOSABLE PROPHY ANGLE | St. George Technology, Inc. |
| 2 Oct 2002 | K022264 | CLEAN 'N' OIL | Svenska Dental Instruments AB |
| 4 Mar 2002 | K020137 | AHP-66 4:1 REDUCTION CONTRANGLE: AHP-88 8:1 REDUCTION CONTRANGLE: AHP-88MP 8:1 REDUCTION CONTRANGLE - PUSH BUTTON | Aseptico, Inc. |
| 28 Jun 2001 | 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 |
| 3 Feb 2000 | K994024 | EXTENDED STRAIGHT ATTACHMENT | Team Technologies, Inc. |
| 8 Jan 1999 | K983574 | STARDENTAL TITAN 3 LUBEFREE MOTOR ATTACHMENTS | Dentalez Group |
| 11 Mar 1998 | K973800 | 23:1 REDUCTION ANGLE | Midwest Dental Products Corp. |
| 8 Oct 1997 | K972569 | E-TYPE SPEED INCREASER CONTRA ANGLE, EXTERNAL IRRIGATION, INTERNAL IRRIGATION | Nsk Nakanishi, Inc. |
| 4 Jun 1997 | K971350 | SERIES XE, SERIES SE, SERIES TE | Micro-Mega Societe Anonyme |
| 12 Sep 1996 | K962540 | E-TYPE CONTRA ANGLE NAC-E | Nsk Nakanishi, Inc. |
| 26 Jun 1996 | K961494 | SERIES XE 140XE,40XE,10XE/SERIES SE 140SE,40SE,10SE/SERIES 10TE | Micro-Mega Societe Anonyme |
| 28 Dec 1995 | K950555 | J SINGLE USE HEAD AND JD REUSABLE HANDLE | Micro-Mega Societe Anonyme |
| 8 Nov 1995 | K954802 | RITE-ANGLE DISPOSABLE PROPHY ANGLES | Ash-USA |
| 31 Mar 1995 | K950773 | PROPHYLAXIS PACK | Transidyne General Corp. |
| 31 Mar 1995 | K950743 | ORAL PROCEDURE PACK | Transidyne General Corp. |
| 13 Feb 1995 | K945834 | PROPHY PRO. | Hyman, Phelps & McNamara, P.C. |
| 27 Jan 1995 | K942480 | M4 CONTRA-ANGLE HANDPIECE | Kerr Corporation (Danbury) |
| 21 Sep 1994 | K933639 | IMKB CONTRA-ANGLES | Coltene/Whaledent AG |
| 5 Aug 1994 | K934781 | BVR HIGH TORQUE HEADS | Bvr Aero Precision Corp. |
| 1 Aug 1994 | K934571 | BVR CONTRA-ANGLE HANDPIECE | Bvr Aero Precision Corp. |
| 6 Jun 1994 | K941009 | DISPOSABLE PROPHY ANGLE | Allpro, Inc. |
| 16 May 1994 | K941189 | DISPOSABLE PROPHYLAXIS ANGLE | Team Technologies, Inc. |
| 27 May 1993 | K923980 | Q3 DISPOSABLE PROPHY ANGLE | Q3 Special Products, Inc. |
| 4 Jun 1985 | K850294 | CANAL FINDER | Roseburg SA |
| 1 Apr 1985 | K844989 | FLO-PHORESIS - DESENSITIZER | Eastco, Inc. |
| 25 Mar 1985 | K850344 | AM-40 POWER OPTIC AIR MOTOR POWER OPTIC CONTRA ANG | Midwest |
| 25 Jun 1982 | K821686 | DENSCO PROPHY ANGLE | Teledyne Densco |
| 4 Aug 1980 | K801688 | TORX HANDPIECE CONTRA ANGLES ATTACHMENTS | Pacific Dental Corp. |
| 10 Apr 1980 | K800735 | U-STYLE ADAPTER | American Midwest |
| 6 Dec 1979 | K792445 | MW STRAIGHT ATTACHMENT | Midwest |
| 15 Jun 1979 | K790722 | PROPHYLAXIS ANGLE | Young Innovations Inc |
| 26 May 1978 | K780752 | PROPHYLAXIS ANGLE | Young Innovations Inc |
| 17 Feb 1978 | K780213 | HANDPIECE, LIFT, ENDO | Kerr Corporation (Danbury) |
| 16 Feb 1978 | K780199 | PROPHY ANGLES, R&R | Ransom & Randolph. LLC. |
Official records: FDA product classification for EGS · 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