Unit, Electrosurgical, And Accessories, Dental

Product Code: EKZ

Dental Microwave Medical Products

Definition: Radiation Emitting Electronic Product Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Co

Applicable Standards: No Standard Applicable. General Radiological Health Requirements Apply. [1000-1005]

Code of Federal Regulations: 872.4920


Radiation TypeMicrowave EMF
Radition SafetyAbbreviated
Annual ReportsNo

Products Classified as EKZ

1236Unit, Electrosurgical, And Accessories, DentalDental Electrosurgical Unit And Accessories.

Total Product Life Cycle (TPLC) Devices

1236Unit, Electrosurgical, And Accessories, DentalDental Electrosurgical Unit And Accessories.

FDA Consensus Standards

Unit, Electrosurgical, And Accessories, Dental [32309]21 CFR §872.4920 🔎

Pre-market Notifications for EKZ

K213477Root ZX3J. Morita USA, Inc.
K071632PERFECT TISSUE CONTOURING SYSTEM IICOLTENE/WHALEDENT INC.
K063468THE FUGO BLADE FOR DENTISTRYMEDISURG LTD.
K052622MACAN MODEL MC-4A DENTAL ELECTROSURGICAL UNITMACAN ENGINEERING CO.
K050735MC6AMACAN ENGINEERING CO.
K020080BONART ART-E1 ELECTROSURGERY UNITDIAGNOSTIC DATA, INC.
K001560ODONTOSURGE 3ODONTO-WAVE
K000768WALLACH QUANTUM 500 ELECTROSURGICAL GENERATORWALLACH SURGICAL DEVICES, INC.
K982229BI-DENTVALLEY FORGE SCIENTIFIC CORP.
K981390ODONTOSURGE 2PERIOGIENE
K962445ARTHROCARE DENTAL ELECTROSURGERY SYSTEMARTHROCARE CORP.
K955176DENTO-SURGEELLMAN INTL., INC.
K950239SENSIMATIC 500SEPARKELL, INC.
K925116ELECTROSURGICAL ELECTRODEPREMIER
K921604TOUCH N' HEAT, MODIFICATIONANALYTIC TECHNOLOGY

Global Unique Device Identification Database

00304040004999UNIT, ELECTROSURGICAL, AND ACCESSORIES, DENTAL
00304040004982UNIT, ELECTROSURGICAL, AND ACCESSORIES, DENTAL
00304040004975UNIT, ELECTROSURGICAL, AND ACCESSORIES, DENTAL
00304040004968UNIT, ELECTROSURGICAL, AND ACCESSORIES, DENTAL
00304040004951UNIT, ELECTROSURGICAL, AND ACCESSORIES, DENTAL
00304040004944UNIT, ELECTROSURGICAL, AND ACCESSORIES, DENTAL
00304040004937UNIT, ELECTROSURGICAL, AND ACCESSORIES, DENTAL
00304040004920UNIT, ELECTROSURGICAL, AND ACCESSORIES, DENTAL
00304040004913UNIT, ELECTROSURGICAL, AND ACCESSORIES, DENTAL
00304040004906UNIT, ELECTROSURGICAL, AND ACCESSORIES, DENTAL
00304040004890UNIT, ELECTROSURGICAL, AND ACCESSORIES, DENTAL
00304040004883UNIT, ELECTROSURGICAL, AND ACCESSORIES, DENTAL
00304040004876UNIT, ELECTROSURGICAL, AND ACCESSORIES, DENTAL
00304040004869UNIT, ELECTROSURGICAL, AND ACCESSORIES, DENTAL
00304040004852UNIT, ELECTROSURGICAL, AND ACCESSORIES, DENTAL

Maude Adverse Events

SYBRONENDOSYBRONENDO2018-12-26
SYBRONENDOSYBRONENDO2018-12-20
SYBRONENDOSYBRONENDO2018-12-19
SYBRONENDOSYBRONENDO2018-08-24
SENSIMATICPARKELL, INC.2018-07-27
SYBRONENDOSYBRONENDO2018-05-24
DENTO-SURG 90 F.F.P.F EMCELLMAN INTERNATIONAL2014-03-26
ART-E1 ELECTROSURGERY UNITBONART CO. LTD.2009-07-27
DENTO-SURGEELLMAN INTERNATIONAL INC.2004-03-26
DENTO-SURG 90 FFPELLMAN INTERNATIONAL INC.2000-07-17
STROBEX COMPACTCOLTENE/WHALEDENT1999-09-17
ELECTROSURGICAL COAGULATION SUCTION TUBE W/STYLETEDWARD WECK, INC.1993-02-15
N/AELECTRO SURGICLAL UNIT ESUVALLEY LAB1992-06-09

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