EKZ · Class II · 21 CFR 872.4920

FDA Product Code EKZ: Unit, Electrosurgical, And Accessories, Dental

Leading manufacturers include Macan Engineering Co., Coulter Electronics, Inc. and Ipco Corp..

19
Total
19
Cleared
135d
Avg days
1983
Since
Stable submission activity - 0 submissions in the last 2 years

FDA 510(k) Cleared Unit, Electrosurgical, And Accessories, Dental Devices (Product Code EKZ)

19 devices
1–19 of 19
Cleared Aug 03, 2022
Root ZX3
K213477
J. Morita USA, Inc.
Dental · 278d
Cleared Oct 18, 2007
PERFECT TISSUE CONTOURING SYSTEM II
K071632
Coltene/Whaledent, Inc.
Dental · 126d
Cleared Apr 18, 2007
THE FUGO BLADE FOR DENTISTRY
K063468
Medisurg , Ltd.
Dental · 153d
Cleared Dec 09, 2005
MACAN MODEL MC-4A DENTAL ELECTROSURGICAL UNIT
K052622
Macan Engineering Co.
Dental · 77d
Cleared May 23, 2005
MC6A
K050735
Macan Engineering Co.
Dental · 63d
Cleared Apr 29, 2003
X O ODONTOSURGE 4
K023672
Xo Care A/S
Dental · 179d
Cleared Feb 19, 2002
BONART ART-E1 ELECTROSURGERY UNIT
K020080
Diagnostic Data, Inc.
Dental · 41d
Cleared Aug 24, 2000
ODONTOSURGE 3
K001560
Odonto-Wave
Dental · 97d
Cleared Apr 11, 2000
WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR
K000768
Wallach Surgical Devices, Inc.
Dental · 33d
Cleared Aug 13, 1998
BI-DENT
K982229
Valley Forge Scientific Corp.
Dental · 90d
Cleared Jun 11, 1998
ODONTOSURGE 2
K981390
Periogiene
Dental · 56d
Cleared Jul 30, 1996
ARTHROCARE DENTAL ELECTROSURGERY SYSTEM
K962445
Arthrocare Corp.
Dental · 36d
Cleared Apr 15, 1996
DENTO-SURGE
K955176
Ellman Intl., Inc.
Dental · 154d
Cleared Jun 06, 1995
SENSIMATIC 500SE
K950239
Parkell, Inc.
Dental · 137d
Cleared Mar 01, 1994
ELECTROSURGICAL ELECTRODE
K925116
Premier
Dental · 508d
Cleared Aug 24, 1992
TOUCH N' HEAT, MODIFICATION
K921604
Analytic Technology
Dental · 150d
Cleared Dec 27, 1985
SATALEC SERVOTOME
K852522
Spelna, Inc.
Dental · 196d
Cleared May 29, 1985
STROBEX ULTRON ELECTROSURGE-DENTAL UNIT
K850666
Ipco Corp.
Dental · 98d
Cleared May 16, 1983
DIFF 4 SYSTEM
K830441
Coulter Electronics, Inc.
Hematology · 95d

About Product Code EKZ - Regulatory Context

510(k) Submission Activity

19 total 510(k) submissions under product code EKZ since 1983, with 19 receiving FDA clearance (average review time: 135 days).

Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.