Dental Device Guide
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Surgical devices · 21 CFR 872 Subpart E

Dental Electrosurgical Unit and Accessories

FDA device type “Unit, Electrosurgical, And Accessories, Dental”.

FDA codeEKZClass221 CFR872.4920Pathway510(k)
Companies listing it
97 makers
Brands and models
9
510(k) clearances
191 in five years
FDA name
Unit, Electrosurgical, And Accessories, Dental
1983: 11985: 21992: 11994: 11995: 11996: 21998: 22000: 22002: 12003: 12005: 22007: 22022: 119801990200020102020

510(k) clearances per year, 1976–2026

Companies that list EKZ

9 companies currently list this device type with FDA.

CompanyCountryRoleBrands and models listedClearancesLatest
Parkell, IncUnited StatesMaker—582025
Satelec - Acteon GroupUnited StatesMakerUnit Electrosurgical and Accessories Dental182024
Coltene/Whaledent AGSwitzerlandMakerPerFect TCS II452022
Bonart Co., Ltd.TaiwanMakerART-E1 ELECTROSURGERY UNIT142017
J. Morita MFG Corp.JapanMakerROOT ZX3 · RZX3——
Cynosure LLCUnited StatesMakerDento-Surg 90 F.F.P.——
Macan Genesis Manufacturing LLCUnited StatesMakerMACAN Model MC-4A Dental Electrosurgery Unit · Radiosurge MC6A——
Blue Line Sterilization Services LLCUnited StatesContract sterilizerThe Fugo Blade For Dentistry——
Oketz Logistics LLCUnited StatesRepacker / relabeler———

510(k) clearances

Decided510(k)DeviceApplicant
3 Aug 2022K213477Root ZX3J. Morita USA, Inc.
18 Oct 2007K071632PERFECT TISSUE CONTOURING SYSTEM IIColtene/Whaledent AG
18 Apr 2007K063468THE FUGO BLADE FOR DENTISTRYMedisurg , Ltd.
9 Dec 2005K052622MACAN MODEL MC-4A DENTAL ELECTROSURGICAL UNITMacan Engineering Co.
23 May 2005K050735MC6AMacan Engineering Co.
29 Apr 2003K023672X O ODONTOSURGE 4Xo Care A/S
19 Feb 2002K020080BONART ART-E1 ELECTROSURGERY UNITDiagnostic Data, Inc.
24 Aug 2000K001560ODONTOSURGE 3Odonto-Wave
11 Apr 2000K000768WALLACH QUANTUM 500 ELECTROSURGICAL GENERATORWallach Surgical Devices, Inc.
13 Aug 1998K982229BI-DENTValley Forge Scientific Corp.
11 Jun 1998K981390ODONTOSURGE 2Perio-Giene
30 Jul 1996K962445ARTHROCARE DENTAL ELECTROSURGERY SYSTEMArthrocare Corp.
15 Apr 1996K955176DENTO-SURGEEllman Intl., Inc.
6 Jun 1995K950239SENSIMATIC 500SEParkell, Inc
1 Mar 1994K925116ELECTROSURGICAL ELECTRODEPremier
24 Aug 1992K921604TOUCH N' HEAT, MODIFICATIONAnalytic Technology
27 Dec 1985K852522SATALEC SERVOTOMESpelna, Inc.
29 May 1985K850666STROBEX ULTRON ELECTROSURGE-DENTAL UNITIpco Corp.
16 May 1983K830441DIFF 4 SYSTEMCoulter Electronics, Inc.

Official records: FDA product classification for EKZ · 21 CFR 872.4920.

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