Dental Device Guide
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Surgical devices · 21 CFR 872 Subpart E

Caries Removal & Cavity Preparation Hydrokinetic Dental System

FDA device type “System, Dental, Hydrokinetic, Caries Removal & Cavity Preparation”.

FDA codeMXFClass221 CFR872.4120Pathway510(k)
Companies listing it
11 makers
Brands and models
1
510(k) clearances
50 in five years
FDA name
System, Dental, Hydrokinetic, Caries Removal & Cavity Preparation
1999: 22002: 22003: 119801990200020102020

510(k) clearances per year, 1976–2026

Companies that list MXF

1 company currently list this device type with FDA.

CompanyCountryRoleBrands and models listedClearancesLatest
Megagen Implant Co., Ltd.South KoreaMakerPowered Laser Surgical Instrument302026

510(k) clearances

Decided510(k)DeviceApplicant
3 Feb 2003K022803WATERLASE FOR APICOECTOMYBiolase Technology, Inc.
12 Feb 2002K013908WATERLASE MILLENNIUMBiolase Technology, Inc.
18 Jan 2002K012511WATERLASE MILLENNIUMBiolase Technology, Inc.
27 May 1999K990908MILLENNIUMEndo Technic Corp.
24 Feb 1999K990219MODIFICATION OF MILLENNIUMBiolase Technology, Inc.

Official records: FDA product classification for MXF · 21 CFR 872.4120.

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026