EGS · Class I · 21 CFR 872.4200

FDA Product Code EGS: Handpiece, Contra- And Right-angle Attachment, Dental

Leading manufacturers include Saeshin Precision Co., Ltd., Nakanishi, Inc. and Micro-Mega Societe Anonyme.

73
Total
73
Cleared
153d
Avg days
1978
Since
Declining activity - 2 submissions in the last 2 years vs 5 in the prior period
Review times increasing: avg 252d recently vs 150d historically

FDA 510(k) Cleared Handpiece, Contra- And Right-angle Attachment, Dental Devices (Product Code EGS)

73 devices
1–24 of 73
Cleared Sep 15, 2025
Disposable Prophy Angle (3399-60, 3399-090, 3399-105)
K251869
Premium Plus (Dongguan) Limited
Dental · 89d
Cleared May 28, 2025
Disposable Prophy Angle
K240950
Pacific Care Limited
Dental · 415d
Cleared Sep 19, 2024
Star E900 Handpiece Series
K240183
Dentalez, Inc., Stardental Division
Dental · 240d
Cleared May 24, 2023
General Cutting Straight
K230106
Nakanishi, Inc.
Dental · 131d
Cleared Nov 17, 2022
FX Contra
K222518
Nakanishi, Inc.
Dental · 90d
Cleared Nov 07, 2022
Lotus Prophy Angle
K220346
Ajk Engineering, Inc.
Dental · 273d
Cleared Nov 07, 2022
Smooth Drive contra angle and straight handpieces
K220874
Lares Research
Dental · 227d
Cleared Jul 29, 2022
Dental Handpiece, Model CA160, CA160L, and CA500L
K220577
Micro-Nx Co., Ltd.
Dental · 151d
Cleared Dec 21, 2021
SURGmatic S15 L Pro
K213139
Kavo Dental GmbH
Dental · 85d
Cleared Oct 27, 2020
General Cutting Contra Handpiece
K202960
Nakanishi, Inc.
Dental · 27d
Cleared Nov 26, 2019
TRAUS Dental Handpieces
K182892
Saeshin Precision Co., Ltd.
Dental · 407d
Cleared Apr 16, 2019
General Cutting Contra Handpiece
K182999
Nakanishi, Inc.
Dental · 168d
Cleared Jan 31, 2019
STRONG Dental Handpieces
K181129
Saeshin Precision Co., Ltd.
Dental · 276d
Cleared Jan 05, 2018
STRONG Dental Handpieces
K171436
Saeshin Precision Co., Ltd.
Dental · 234d
Cleared Jul 18, 2017
Bonart Dental Handpieces (ART), Disposable Prophy Angle (PROFORMANCE)
K162856
Bonart Co., Ltd.
Dental · 279d
Cleared Jan 19, 2017
Titan 3 Low Speed Angle Attachments
K162397
Dentalez, Inc.
Dental · 146d
Cleared Nov 24, 2015
LUXATOR LX HANDPIECE
K133178
Directa AB
Dental · 768d
Cleared Jul 31, 2015
STRONG Dental Handpieces
K143418
Saeshin Precision Co., Ltd.
Dental · 245d
Cleared Jul 02, 2015
Endo 6:1, T1 Line Endo 6 L, SIRONiTi Apex, T1 Spray
K150750
Sirona Dental Systems GmbH
Dental · 101d
Cleared Oct 23, 2014
U-TYPE CONTRA ANGLE, U-TYPE SECTIONAL CONTRA ANGLE
K141125
Handpiece Headquarters
Dental · 175d
Cleared Jan 31, 2014
SANAO 200L, SANAO 40 /SANAO 40L, SANAO 10L, SANAO PSI / SANAO PSO, SANAO 40ST
K132356
Scican GmbH
Dental · 186d
Cleared Feb 28, 2013
TI-MAX Z45
K121901
Nakanishi, Inc.
Dental · 244d
Cleared Apr 17, 2012
VIGOR A LOW SPEED AIR MOTOR, VIGOR C LOW SPEED CONTRA-ANGLE HANDPIECES, VIGOR S LOW SPEED STRAIGHT HANDPIECES
K112305
Thunder Tiger Corp.
Dental · 250d
Cleared Mar 16, 2012
ENDO-EXPRESS (R) HANDPIECE
K111541
Essential Dental Systems, Inc.
Dental · 288d

About Product Code EGS - Regulatory Context

510(k) Submission Activity

73 total 510(k) submissions under product code EGS since 1978, with 73 receiving FDA clearance (average review time: 153 days).

Submission volume has declined in recent years - 2 submissions in the last 24 months compared to 5 in the prior period.

FDA 510(k) Review Time - EGS Product Code

Recent submissions under EGS have taken an average of 252 days to reach a decision - up from 150 days historically. Manufacturers should account for longer review timelines in current project planning.

EGS devices are reviewed by the Dental panel. Browse all Dental devices →