Impla-NX (Model: ISE-270M)

• FDA 510(k) K201192 decided 21 May 2021 Active
• EUDAMED Active

510(k) Number

K201192 ↗

FDA product code

EBW

Device class

Class I

Regulation

21 CFR Part 872.4200

Advisory committee

Dental

FDA decision

SESE Substantially Equivalent

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Source: 510k-lineage (choiben314), CC BY 4.0

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Other devices filed under FDA product code EBW (Controller, Foot, Handpiece And Cord).

• A-DEC/W&H ELECTRIC MOTOR, MODEL EA-50LT by A-Dec, Inc.
• Surgic Pro, Surgic Pro+ by NAKANISHI INC.
• MARK 20 AND MARK 25 HAND ENGINE CONTROLLER by Bell Intl., Inc.
• COXO C-Sailor Pro by Foshan COXO Medical Instrument Co., Ltd.
• SURGIC IV IMPLANT CONTROL UNIT by NAKANISHI INC.
• EXPERTsurg LUX 1.008.3500 by KaVo Dental GmbH
• TRAUS SUS10 TRAUS CRB27LX by Saeshin Precision Co., Ltd.
• INTEGO 6427285 by SIRONA Dental Systems GmbH
• MODEL 45E HANDENGINE & CONTROLLER, MODEL 45EH HANDENGINE & CONTROLLER, MODEL RX-100 HANDENGINE & CONTROLLER, MODEL ETELN by Bell Intl., Inc.
• S-11 L 30058001 by W&H Dentalwerk Burmoos

• Dental Handpiece, Wireless Endodontic Handpiece, endoit (Model: EH-C500)

  Class I

  FDA 510(k) K232810 Active Cleared 9 Nov 2023 GUDID on market

• Td-C60

  Class I

  FDA 510(k) K161500 Active Cleared 22 Feb 2017 GUDID on market

• CA500L

  Class I

  FDA 510(k) K220577 Active Cleared 29 Jul 2022 GUDID on market

• El-M40TT

  Class IIa

  CE/MDD

See all devices from Micro-Nx Co., Ltd. →