FDA Product Code EKZ: Unit, Electrosurgical, And Accessories, Dental
Leading manufacturers include Macan Engineering Co., Valley Forge Scientific Corp. and Wallach Surgical Devices, Inc..
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
Cleared
Aug 03, 2022
Root ZX3
J. Morita USA, Inc.
Dental
278d
Cleared
Oct 18, 2007
PERFECT TISSUE CONTOURING SYSTEM II
Coltene/Whaledent, Inc.
Dental
126d
Cleared
Dec 09, 2005
MACAN MODEL MC-4A DENTAL ELECTROSURGICAL UNIT
Macan Engineering Co.
Dental
77d
Cleared
May 23, 2005
MC6A
Macan Engineering Co.
Dental
63d
Cleared
Apr 11, 2000
WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR
Wallach Surgical Devices, Inc.
Dental
33d
Cleared
Aug 13, 1998
BI-DENT
Valley Forge Scientific Corp.
Dental
90d
Cleared
Jun 11, 1998
ODONTOSURGE 2
Periogiene
Dental
56d
Cleared
Jul 30, 1996
ARTHROCARE DENTAL ELECTROSURGERY SYSTEM
Arthrocare Corp.
Dental
36d
Cleared
Apr 15, 1996
DENTO-SURGE
Ellman Intl., Inc.
Dental
154d
Cleared
Jun 06, 1995
SENSIMATIC 500SE
Parkell, Inc.
Dental
137d
Cleared
May 29, 1985
STROBEX ULTRON ELECTROSURGE-DENTAL UNIT
Ipco Corp.
Dental
98d
Cleared
May 16, 1983
DIFF 4 SYSTEM
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.