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ELL — Teeth, Porcelain Class II

FDA Device Classification

Classification Details

Product Code
ELL
Device Class
Class II
Regulation Number
872.3920
Submission Type
Review Panel
DE
Medical Specialty
Dental
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K240586hangzhou thales medtech coAdditive Manufacturing Zirconia Customized RestorationOctober 3, 2024
K203072franz biotechFranz Zirconia Dental CrownJanuary 19, 2022
K162043nobel biocareNobelProcera HT ML FCZ BridgeNovember 22, 2016
K153534nobel biocareNobelProcera HT ML Full Contour Zirconia CrownJune 6, 2016
K071182nobel biocarePROCERA BRIDGE ZIRCONIA 9 UNITS-14 UNITS, MODELS 30-4004 TO 30-4013July 11, 2007
K060530lifecore biomedicalSD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING. MODEL 45301. RD CERAMIC COPING FMay 22, 2006
K041283nobel biocarePROCERA BRIDGE ZIRCONIAMay 28, 2004
K032562nobel biocarePROCEARA COPINGS AND PONTICFebruary 6, 2004
K965216argen precious metalsARGI-SATIN OR OPTI0-STARFebruary 27, 1997
K960770davis schottlander and davisMATCHMAKER/PROPAQUE PORCELAINNovember 19, 1996
K960480videntIN-CERAM SPINELL KIT FOR CELAV MODEL V56-001/E63013March 15, 1996
K930835ivoclar north americaVIVOPERL-PE, VIVAPERL-PE ORTHOTYP/ORTHOTYP AJuly 22, 1994
K932012chemichlCAPSNovember 3, 1993
K931808degussaDUCERAGOLD, DUCERATINNovember 3, 1993
K924821unicepMICRODOSE PORCELAIN ETCHANTMarch 16, 1993
K924823unicepMICRODOSE SILANEMarch 16, 1993
K923926ivoclar north americaIPS CERAMIC ETCHING GELOctober 27, 1992
K920460pulpdent4% ACIDULATED PHOSPHATE FLUORIDE ETCHING GELApril 28, 1992
K910569jeneric/pentronTYCERAMICApril 15, 1991
K910303jeneric/pentronSYSNPAR PORCELAINMarch 8, 1991