Product Code: EKZ FDA class 2 21 CFR 872.4920

Unit, Electrosurgical, And Accessories, Dental

Dental

The Dental Electrosurgical Unit and Accessories is a device that delivers controlled high-frequency electrical current through an active electrode to cut, coagulate, or ablate soft oral tissues during dental surgical procedures such as gingivectomy, crown lengthening, and implant exposure. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket clearance and compliance with special controls. The product code is EKZ, regulated under 21 CFR 872.4920 in the Dental (DE) specialty. This device is eligible for third-party review.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: EKZ
Device Class: FDA class 2
Regulation Number: 872.4920
Medical Specialty: Dental
Review Panel: DE
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 19 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K213477	Root ZX3	Aug 03, 2022	Substantially Equivalent	J. Morita USA, Inc.
K071632	PERFECT TISSUE CONTOURING SYSTEM II	Oct 18, 2007	Substantially Equivalent	Coltene/Whaledent, Inc.
K063468	THE FUGO BLADE FOR DENTISTRY	Apr 18, 2007	Substantially Equivalent	Medisurg , Ltd.
K052622	MACAN MODEL MC-4A DENTAL ELECTROSURGICAL UNIT	Dec 09, 2005	Substantially Equivalent	Macan Engineering Co.
K050735	MC6A	May 23, 2005	Substantially Equivalent	Macan Engineering Co.
K023672	X O ODONTOSURGE 4	Apr 29, 2003	Substantially Equivalent	Xo Care A/S
K020080	BONART ART-E1 ELECTROSURGERY UNIT	Feb 19, 2002	Substantially Equivalent	Diagnostic Data, Inc.
K001560	ODONTOSURGE 3	Aug 24, 2000	Substantially Equivalent	Odonto-Wave
K000768	WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR	Apr 11, 2000	Substantially Equivalent	Wallach Surgical Devices, Inc.
K982229	BI-DENT	Aug 13, 1998	Substantially Equivalent	Valley Forge Scientific Corp.
K981390	ODONTOSURGE 2	Jun 11, 1998	Substantially Equivalent	Periogiene
K962445	ARTHROCARE DENTAL ELECTROSURGERY SYSTEM	Jul 30, 1996	Substantially Equivalent	Arthrocare Corp.
K955176	DENTO-SURGE	Apr 15, 1996	Substantially Equivalent	Ellman Intl., Inc.
K950239	SENSIMATIC 500SE	Jun 06, 1995	Substantially Equivalent	Parkell, Inc.
K925116	ELECTROSURGICAL ELECTRODE	Mar 01, 1994	Substantially Equivalent	Premier
K921604	TOUCH N' HEAT, MODIFICATION	Aug 24, 1992	Substantially Equivalent	Analytic Technology
K852522	SATALEC SERVOTOME	Dec 27, 1985	Substantially Equivalent	Spelna, Inc.
K850666	STROBEX ULTRON ELECTROSURGE-DENTAL UNIT	May 29, 1985	Substantially Equivalent	Ipco Corp.
K830441	DIFF 4 SYSTEM	May 16, 1983	Substantially Equivalent	Coulter Electronics, Inc.