EBW — Controller, Foot, Handpiece And Cord Class I

FDA Device Classification

Classification Details

Product Code
EBW
Device Class
Class I
Regulation Number
872.4200
Submission Type
Review Panel
DE
Medical Specialty
Dental
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K251407saeshin precision coMotor Handpiece and Control Unit (SDI10)January 30, 2026
K251701dentalez, inc., stardental divisionStar E900 Electric SystemJanuary 12, 2026
K251811dentsply sironaMotor and Apex Module (MaAM)August 25, 2025
K231562micro-nx coELEC ENGINE (Model: ISE-170L)July 18, 2025
K242646guilin aesthedent medical instruments coDental Implant UnitApril 11, 2025
K233288nakanishiNLZ Built-In Motor SystemJune 24, 2024
K233117nakanishiSurgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON-OPT)June 20, 2024
K230895cefla s.cCEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMr L FLUO, i-MMs, i-MMs FLUO; i-XR3April 1, 2024
K231864codent technical industry coFiber Optic Brushless Electronic Micromotor, model: iM100March 11, 2024
K211358guilin woodpecker medical instrument coImplanter incl. AccessoriesNovember 21, 2022
K220831foshan coxo medical instrument coDental Implantation Systems, Dental Electrical MotorsSeptember 27, 2022
K213022cefla s.cCEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMs, i-XR3, i-XR3 L, i-XS4, handy POMay 9, 2022
K202075foshan cicada dental instrument coDental Electric MotorMarch 11, 2022
K201191micro-nx coELEC-LEDFebruary 7, 2022
K203706guilin woodpecker medical instrument coDental Electric MotorJanuary 13, 2022
K201192micro-nx coImpla-NX (Model: ISE-270M)May 21, 2021
K201292saeshin precision coTRAUS SIP20February 11, 2021
K193341dentium coiCTmotor (WL-1)September 4, 2020
K180845handpiece headquarters - hprMaxima Electric SystemJuly 25, 2019
K181858w and h dentalwerk buermoosElectric Handpiece MotorMarch 26, 2019