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510(k) K023672

Device
X O ODONTOSURGE 4
Applicant
Xo Care A/S
510(k) number
K023672
Product code
EKZ
Decision
Substantially Equivalent (SESE)
Decision date
2003-04-29
Date received
2002-11-01
Regulation
872.4920
Classification name
Unit, Electrosurgical, And Accessories, Dental
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
JAMES DIEROFF
Address
1100 S. Coast Hwy. Suite 204 Lagunga Beach CA US 92651 92651

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code EKZ#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K213477Root ZX3J. Morita USA, Inc.2022-08-03
K071632PERFECT TISSUE CONTOURING SYSTEM IIColtene/Whaledent, Inc.2007-10-18
K063468THE FUGO BLADE FOR DENTISTRYMedisurg , Ltd.2007-04-18
K052622MACAN MODEL MC-4A DENTAL ELECTROSURGICAL UNITMacan Engineering Co.2005-12-09
K050735MC6AMacan Engineering Co.2005-05-23
K020080BONART ART-E1 ELECTROSURGERY UNITDiagnostic Data, Inc.2002-02-19
K001560ODONTOSURGE 3Odonto-Wave2000-08-24
K000768WALLACH QUANTUM 500 ELECTROSURGICAL GENERATORWallach Surgical Devices, Inc.2000-04-11
K982229BI-DENTValley Forge Scientific Corp.1998-08-13
K981390ODONTOSURGE 2Periogiene1998-06-11
K962445ARTHROCARE DENTAL ELECTROSURGERY SYSTEMArthrocare Corp.1996-07-30
K955176DENTO-SURGEEllman Intl., Inc.1996-04-15
K950239SENSIMATIC 500SEParkell, Inc.1995-06-06
K925116ELECTROSURGICAL ELECTRODEPremier1994-03-01
K921604TOUCH N' HEAT, MODIFICATIONAnalytic Technology1992-08-24