Product code EGS
- Device name
- Handpiece, Contra- And Right-Angle Attachment, Dental
- Medical specialty
- Dental
- Device class
- 1
- Regulation number
- 872.4200
- Review panel
- DE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251869 | Disposable Prophy Angle (3399-60, 3399-090, 3399-105) | Premium Plus (Dongguan) Limited | 2025-09-15 |
| K240950 | Disposable Prophy Angle | Pacific Care Limited | 2025-05-28 |
| K240183 | Star E900 Handpiece Series | Dentalez, Inc., Stardental Division | 2024-09-19 |
| K230106 | General Cutting Straight | Nakanishi, Inc. | 2023-05-24 |
| K222518 | FX Contra | Nakanishi, Inc. | 2022-11-17 |
| K220874 | Smooth Drive contra angle and straight handpieces | Lares Research | 2022-11-07 |
| K220346 | Lotus Prophy Angle | Ajk Engineering, Inc. | 2022-11-07 |
| K220577 | Dental Handpiece, Model CA160, CA160L, and CA500L | Micro-Nx Co., Ltd. | 2022-07-29 |
| K213139 | SURGmatic S15 L Pro | Kavo Dental GmbH | 2021-12-21 |
| K202960 | General Cutting Contra Handpiece | Nakanishi, Inc. | 2020-10-27 |
| K182892 | TRAUS Dental Handpieces | Saeshin Precision Co., Ltd. | 2019-11-26 |
| K182999 | General Cutting Contra Handpiece | Nakanishi, Inc. | 2019-04-16 |
| K181129 | STRONG Dental Handpieces | Saeshin Precision Co., Ltd. | 2019-01-31 |
| K171436 | STRONG Dental Handpieces | Saeshin Precision Co., Ltd. | 2018-01-05 |
| K162856 | Bonart Dental Handpieces (ART), Disposable Prophy Angle (PROFORMANCE) | Bonart Co., Ltd. | 2017-07-18 |
| K162397 | Titan 3 Low Speed Angle Attachments | Dentalez, Inc. | 2017-01-19 |
| K133178 | LUXATOR LX HANDPIECE | Directa AB | 2015-11-24 |
| K143418 | STRONG Dental Handpieces | Saeshin Precision Co., Ltd. | 2015-07-31 |
| K150750 | Endo 6:1, T1 Line Endo 6 L, SIRONiTi Apex, T1 Spray | Sirona Dental Systems GmbH | 2015-07-02 |
| K141125 | U-TYPE CONTRA ANGLE, U-TYPE SECTIONAL CONTRA ANGLE | Handpiece Headquarters | 2014-10-23 |
| K132356 | SANAO 200L, SANAO 40 /SANAO 40L, SANAO 10L, SANAO PSI / SANAO PSO, SANAO 40ST | Scican GmbH | 2014-01-31 |
| K121901 | TI-MAX Z45 | Nakanishi, Inc. | 2013-02-28 |
| 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 |
| K111541 | ENDO-EXPRESS (R) HANDPIECE | Essential Dental Systems, Inc. | 2012-03-16 |
| K103697 | TORQTECH | J. Morita USA, Inc. | 2012-01-20 |
| K111532 | MONTBLANC SURGICAL CONTRA-ANGLE AND STRAIGHT HANDPIECE | Anthogyr Sas | 2011-10-07 |
| K103158 | STRAIGHT HANDPIECE ADAPTER; CONTRA HANDPIECE ADAPTER; TWIST HANDPIECE ADAPTER; FLEX HANDPIECE ADAPTER | Angstrom Mfg., Inc. | 2011-02-07 |
| K103157 | DISPOSABLE PROPHY ANGLE; DISPOSABLE PROPHY ANGLE | Angstrom Mfg., Inc. | 2011-01-24 |
| K100854 | PREMIUM PLUS DISPOSABLE PROPHY ANGLE MODEL 3399 | Premium Plus International Limited | 2010-12-09 |
| K100192 | STRONG DENTAL HANDPIECES | Saeshin Precision Co., Ltd. | 2010-02-04 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| D77142131771 | Dental City | ICP, INC. | 2026-05-27 |
| D77142132771 | Dental City | ICP, INC. | 2026-05-27 |
| D77142133771 | Dental City | ICP, INC. | 2026-05-27 |
| D77142130771 | Dental City | ICP, INC. | 2026-05-27 |
| 08809260470279 | TRAUS | Saeshin Precision Co., Ltd. | 2026-03-31 |
| H66824130771 | FORTIS | Keystone Industries | 2022-11-30 |
| H66824131771 | FORTIS | Keystone Industries | 2022-11-30 |
| H66824132771 | FORTIS | Keystone Industries | 2022-11-30 |
| H66824133771 | FORTIS | Keystone Industries | 2022-11-30 |
| H66890398551 | Nero | Keystone Industries | 2022-11-30 |
| H66895391701 | Nero | Keystone Industries | 2022-11-30 |
| H65811262391 | Henry Schein | HENRY SCHEIN, INC. | 2020-06-17 |
| J021000011041 | S-11 | W & H Dentalwerk Bürmoos GmbH | 2019-09-08 |
| J021000011021 | S-11 | W & H Dentalwerk Bürmoos GmbH | 2019-09-08 |
| 08800000995212 | SM3 | Osstem Implant Co., Ltd._Gasan Branch | 2019-04-25 |
| 08800000995229 | SM3 | Osstem Implant Co., Ltd._Gasan Branch | 2019-04-25 |
| 08800000995236 | SM3 | Osstem Implant Co., Ltd._Gasan Branch | 2019-04-25 |
| J021102075501 | WI-75 E/KM | W & H Dentalwerk Bürmoos GmbH | 2018-12-04 |
| 10304040051600 | Henry Schein | HENRY SCHEIN, INC. | 2018-09-24 |
| ENOU19849 | NOU-CLEAN SPRAY | Nouvag AG | 2018-08-15 |
| J021000011001 | Surgical Handpiece S-11 | W & H Dentalwerk Bürmoos GmbH | 2018-04-25 |
| 08809260470040 | TRAUS SUS10 | Saeshin Precision Co., Ltd. | 2016-09-24 |
| 08809260470057 | TRAUS SUS10 | Saeshin Precision Co., Ltd. | 2016-09-24 |
| 08809260470064 | TRAUS SUS10 | Saeshin Precision Co., Ltd. | 2016-09-24 |
| 08809260470071 | TRAUS SUS10 | Saeshin Precision Co., Ltd. | 2016-09-24 |
| 08809260470125 | TRAUS SUS10 | Saeshin Precision Co., Ltd. | 2016-09-24 |
| 08809260470033 | TRAUS SUS10 | Saeshin Precision Co., Ltd. | 2016-09-24 |
| 08809260470026 | TRAUS SUS10 | Saeshin Precision Co., Ltd. | 2016-09-24 |
| 08809260470019 | TRAUS SUS10 | Saeshin Precision Co., Ltd. | 2016-09-24 |
| 08809260470002 | TRAUS SUS10 | Saeshin Precision Co., Ltd. | 2016-09-24 |