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EGD — Wax, Dental, Intraoral Class I

FDA Device Classification

Classification Details

Product Code
EGD
Device Class
Class I
Regulation Number
872.6890
Submission Type
Review Panel
DE
Medical Specialty
Dental
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K020009udentBRACE EZEFebruary 11, 2002
K945535glenroe technologiesGLENROE ORTHO-SILJanuary 27, 1995
K924024heraeus kulzerORTHO WAXNovember 17, 1992
K923586dentsply intlBURNOUT MATERIALSeptember 29, 1992
K914892orion diagnosticaSALIVA-STIMSeptember 2, 1992
K922380dentsply intlBITE RIM WAXJune 16, 1992
K914513heraeus kulzerPALAVIT GMarch 19, 1992
K910676pemacoINTRAORAL DENTAL WAXAugust 21, 1991
K904928kulzerPALAVIT GLCJune 6, 1991
K895561pemacoPEMACO 3000 INTRAORAL DENTAL WAXNovember 6, 1989
K895564pemacoPEMACO BITE BLOCK RODS-MEDIUM SOFT & MEDIUM HARDNovember 6, 1989
K895563pemacoPEMACO BITE WAX SHEETSNovember 6, 1989
K895566pemacoPEMACO ECONOMY BASE PLATE WAX-MEDIUM SOFTNovember 6, 1989
K895562pemacoPEMACO 2000 INTRAORAL DENTAL WAXNovember 6, 1989
K895565pemacoPEMACO ECONOMY BASE PLATE WAX-MEDIUM HARDOctober 24, 1989
K880607columbus dental mfgUTILITY WAX STRIPS, SPEARMINTMarch 31, 1988
K880606columbus dental mfgUTILITY WAX STRIPS, CINNAMONMarch 24, 1988
K863758columbus dental mfgORTHO-BITE WAX WAFEROctober 7, 1986
K854529hygenicINLAY WAX REGULARMarch 10, 1986
K854530hygenicPREMIUM FLEXI-TOUGHMarch 4, 1986