FDA Product Code
FDA Product Code EGS — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Dental
- 21 CFR Citation
- 872.4200
510(k) Clearances — 73 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K251869 | Disposable Prophy Angle (3399-60, 3399-090, 3399-105) | Premium Plus (Dongguan) Limited | 2025-09-15 | Traditional | PDF ↗ |
| K240950 | Disposable Prophy Angle | Pacific Care Limited | 2025-05-28 | Abbreviated | PDF ↗ |
| K240183 | Star E900 Handpiece Series | Dentalez, Inc., Stardental Division | 2024-09-19 | Traditional | PDF ↗ |
| K230106 | General Cutting Straight | Nakanishi, Inc. | 2023-05-24 | Traditional | PDF ↗ |
| K222518 | FX Contra | Nakanishi, Inc. | 2022-11-17 | Traditional | PDF ↗ |
| K220346 | Lotus Prophy Angle | Ajk Engineering, Inc. | 2022-11-07 | Traditional | PDF ↗ |
| K220874 | Smooth Drive contra angle and straight handpieces | Lares Research | 2022-11-07 | Traditional | PDF ↗ |
| K220577 | Dental Handpiece, Model CA160, CA160L, and CA500L | Micro-Nx Co., Ltd. | 2022-07-29 | Traditional | PDF ↗ |
| K213139 | SURGmatic S15 L Pro | Kavo Dental GmbH | 2021-12-21 | Traditional | PDF ↗ |
| K202960 | General Cutting Contra Handpiece | Nakanishi, Inc. | 2020-10-27 | Special | PDF ↗ |
| K182892 | TRAUS Dental Handpieces | Saeshin Precision Co., Ltd. | 2019-11-26 | Traditional | PDF ↗ |
| K182999 | General Cutting Contra Handpiece | Nakanishi, Inc. | 2019-04-16 | Traditional | PDF ↗ |
| K181129 | STRONG Dental Handpieces | Saeshin Precision Co., Ltd. | 2019-01-31 | Traditional | PDF ↗ |
| K171436 | STRONG Dental Handpieces | Saeshin Precision Co., Ltd. | 2018-01-05 | Traditional | PDF ↗ |
| K162856 | Bonart Dental Handpieces (ART), Disposable Prophy Angle (PROFORMANCE) | Bonart Co., Ltd. | 2017-07-18 | Abbreviated | PDF ↗ |
| K162397 | Titan 3 Low Speed Angle Attachments | Dentalez, Inc. | 2017-01-19 | Traditional | PDF ↗ |
| K133178 | LUXATOR LX HANDPIECE | Directa AB | 2015-11-24 | Traditional | PDF ↗ |
| K143418 | STRONG Dental Handpieces | Saeshin Precision Co., Ltd. | 2015-07-31 | Traditional | PDF ↗ |
| K150750 | Endo 6:1, T1 Line Endo 6 L, SIRONiTi Apex, T1 Spray | Sirona Dental Systems GmbH | 2015-07-02 | Traditional | PDF ↗ |
| K141125 | U-TYPE CONTRA ANGLE, U-TYPE SECTIONAL CONTRA ANGLE | Handpiece Headquarters | 2014-10-23 | Traditional | PDF ↗ |
| K132356 | SANAO 200L, SANAO 40 /SANAO 40L, SANAO 10L, SANAO PSI / SANAO PSO, SANAO 40ST | Scican GmbH | 2014-01-31 | Traditional | PDF ↗ |
| K121901 | TI-MAX Z45 | Nakanishi, Inc. | 2013-02-28 | Traditional | PDF ↗ |
| K112305 | VIGOR A LOW SPEED AIR MOTOR, VIGOR C LOW SPEED CONTRA-ANGLE HANDPIECES, VIGOR S LOW SPEED STRAIGHT HANDPIECES | Thunder Tiger Corp. | 2012-04-17 | Abbreviated | PDF ↗ |
| K111541 | ENDO-EXPRESS (R) HANDPIECE | Essential Dental Systems, Inc. | 2012-03-16 | Traditional | PDF ↗ |
| K103697 | TORQTECH | J. Morita USA, Inc. | 2012-01-20 | Traditional | PDF ↗ |
| K111532 | MONTBLANC SURGICAL CONTRA-ANGLE AND STRAIGHT HANDPIECE | Anthogyr Sas | 2011-10-07 | Traditional | PDF ↗ |
| K103158 | STRAIGHT HANDPIECE ADAPTER; CONTRA HANDPIECE ADAPTER; TWIST HANDPIECE ADAPTER; FLEX HANDPIECE ADAPTER | Angstrom Mfg., Inc. | 2011-02-07 | Traditional | PDF ↗ |
| K103157 | DISPOSABLE PROPHY ANGLE; DISPOSABLE PROPHY ANGLE | Angstrom Mfg., Inc. | 2011-01-24 | Traditional | PDF ↗ |
| K100854 | PREMIUM PLUS DISPOSABLE PROPHY ANGLE MODEL 3399 | Premium Plus International Limited | 2010-12-09 | Traditional | PDF ↗ |
| K100192 | STRONG DENTAL HANDPIECES | Saeshin Precision Co., Ltd. | 2010-02-04 | Traditional | PDF ↗ |
| K092053 | MAXIMA-M STRAIGHT ATTACHMENT, MAXIMA-M CONTRA ANGLE SHEATH | Handpiece Headquarters | 2009-08-20 | Traditional | PDF ↗ |
| K061897 | EXCEL CONTRA ANGLE HANDPIECE | Orthosource, Inc. | 2007-02-14 | Abbreviated | PDF ↗ |
| K060317 | ANTHOGYR CONTRA ANGLES AND HANDPIECES | Est. Anthogyr | 2006-04-28 | Traditional | PDF ↗ |
| K060377 | DR DISPOSABLE PROPHY ANGLE MODEL H310 | Dental Resources | 2006-04-26 | Traditional | PDF ↗ |
| K051077 | E-TYPE STRAIGHT HANDPIECE, MODEL AHP-101 | Aseptico, Inc. | 2005-05-03 | Traditional | PDF ↗ |
| K042171 | AX'S ENDO 04, 06, 08, 2.5, 40 , MODELS 50100206, 50100217, 50100218, 50100230, 50100232 | Micro-Mega Societe Anonyme | 2004-11-10 | Traditional | PDF ↗ |
| K032925 | B&R DEVICE | Ronvig A/S | 2003-12-22 | Traditional | PDF ↗ |
| K022505 | CONTRA-ANGLE, MODELS 1059, 5050, 5051, 5055, 5056, 5057, 5059, 5060, 5061, 5062, 5063, 5064, 5065, 5066, 5067, 5068, | NOUVAG AG | 2003-10-01 | Traditional | PDF ↗ |
| K030603 | PROANGLE DISPOSABLE PROPHY ANGLE | Pac-Dent International (Suzhou), Ltd. | 2003-04-14 | Traditional | PDF ↗ |
| K023953 | ST. GEORGE TECHNOLOGY, INC PERFECTION PLUS DISPOSABLE PROPHY ANGLE | St. George Technology, Inc. | 2003-02-14 | Traditional | PDF ↗ |
| K022264 | CLEAN 'N' OIL | Svenska Dental Instruments AB | 2002-10-02 | Traditional | PDF ↗ |
| K020137 | AHP-66 4:1 REDUCTION CONTRANGLE: AHP-88 8:1 REDUCTION CONTRANGLE: AHP-88MP 8:1 REDUCTION CONTRANGLE - PUSH BUTTON | Aseptico, Inc. | 2002-03-04 | Traditional | PDF ↗ |
| 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 | 2001-06-28 | Traditional | PDF ↗ |
| K994024 | EXTENDED STRAIGHT ATTACHMENT | Team Technologies, Inc. | 2000-02-03 | Traditional | PDF ↗ |
| K983574 | STARDENTAL TITAN 3 LUBEFREE MOTOR ATTACHMENTS | Dentalez Group | 1999-01-08 | Traditional | PDF ↗ |
| K973800 | 23:1 REDUCTION ANGLE | Midwest Dental Products Corp. | 1998-03-11 | Traditional | PDF ↗ |
| K972569 | E-TYPE SPEED INCREASER CONTRA ANGLE, EXTERNAL IRRIGATION, INTERNAL IRRIGATION | Nsk Nakanishi, Inc. | 1997-10-08 | Traditional | PDF ↗ |
| K971350 | SERIES XE, SERIES SE, SERIES TE | Micro-Mega Societe Anonyme | 1997-06-04 | Traditional | PDF ↗ |
| K962540 | E-TYPE CONTRA ANGLE NAC-E | Nsk Nakanishi, Inc. | 1996-09-12 | Traditional | PDF ↗ |
| K961494 | SERIES XE 140XE,40XE,10XE/SERIES SE 140SE,40SE,10SE/SERIES 10TE | Micro-Mega Societe Anonyme | 1996-06-26 | Traditional | PDF ↗ |
| K950555 | J SINGLE USE HEAD AND JD REUSABLE HANDLE | Micro-Mega Societe Anonyme | 1995-12-28 | Traditional | PDF ↗ |
| K954802 | RITE-ANGLE DISPOSABLE PROPHY ANGLES | Ash-USA | 1995-11-08 | Traditional | PDF ↗ |
| K950773 | PROPHYLAXIS PACK | Transidyne General Corp. | 1995-03-31 | Traditional | PDF ↗ |
| K950743 | ORAL PROCEDURE PACK | Transidyne General Corp. | 1995-03-31 | Traditional | PDF ↗ |
| K945834 | PROPHY PRO. | Hyman, Phelps & McNamara, P.C. | 1995-02-13 | Traditional | PDF ↗ |
| K942480 | M4 CONTRA-ANGLE HANDPIECE | Kerr Corporation (Danbury) | 1995-01-27 | Traditional | PDF ↗ |
| K933639 | IMKB CONTRA-ANGLES | Micro-Mega | 1994-09-21 | Traditional | PDF ↗ |
| K934781 | BVR HIGH TORQUE HEADS | Bvr Aero Precision Corp. | 1994-08-05 | Traditional | PDF ↗ |
| K934571 | BVR CONTRA-ANGLE HANDPIECE | Bvr Aero Precision Corp. | 1994-08-01 | Traditional | PDF ↗ |
| K941009 | DISPOSABLE PROPHY ANGLE | Allpro, Inc. | 1994-06-06 | Traditional | PDF ↗ |
| K941189 | DISPOSABLE PROPHYLAXIS ANGLE | Team Technologies, Inc. | 1994-05-16 | Traditional | PDF ↗ |
| K923980 | Q3 DISPOSABLE PROPHY ANGLE | Q3 Special Products, Inc. | 1993-05-27 | Traditional | PDF ↗ |
| K850294 | CANAL FINDER | Roseburg SA | 1985-06-04 | Traditional | PDF ↗ |
| K844989 | FLO-PHORESIS - DESENSITIZER | Eastco, Inc. | 1985-04-01 | Traditional | PDF ↗ |
| K850344 | AM-40 POWER OPTIC AIR MOTOR POWER OPTIC CONTRA ANG | Midwest | 1985-03-25 | Traditional | PDF ↗ |
| K821686 | DENSCO PROPHY ANGLE | Teledyne Densco | 1982-06-25 | Traditional | PDF ↗ |
| K801688 | TORX HANDPIECE CONTRA ANGLES ATTACHMENTS | Pacific Dental Corp. | 1980-08-04 | Traditional | PDF ↗ |
| K800735 | U-STYLE ADAPTER | American Midwest | 1980-04-10 | Traditional | PDF ↗ |
| K792445 | MW STRAIGHT ATTACHMENT | Midwest | 1979-12-06 | Traditional | PDF ↗ |
| K790722 | PROPHYLAXIS ANGLE | Young Dental Manufacturing Co. 1, LLC | 1979-06-15 | Traditional | PDF ↗ |
| K780752 | PROPHYLAXIS ANGLE | Young Dental Manufacturing Co. 1, LLC | 1978-05-26 | Traditional | PDF ↗ |
| K780213 | HANDPIECE, LIFT, ENDO | Kerr Corporation (Danbury) | 1978-02-17 | Traditional | PDF ↗ |
| K780199 | PROPHY ANGLES, R&R | Ransom and Randolph | 1978-02-16 | Traditional | PDF ↗ |
Product code EGS · Class I · Dental. Data: openFDA.