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ELM — Denture, Plastic, Teeth Class II

FDA Device Classification

FDA product code ELM covers "Denture, Plastic, Teeth", a Class II medical device regulated under 21 CFR 872.3590. Submissions are reviewed by the Dental panel. At least 20 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
ELM
Device Class
Class II
Regulation Number
872.3590
Submission Type
Review Panel
DE
Medical Specialty
Dental
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K132984ivoclar vivadentSR VIVODENT S, SR ORTHOTYP S, SR ORTHOLINGUAL SJanuary 14, 2014
K122955wright health groupDENTAVIT, MONARCH, ACROTONE, SENATOR, DENTORIUMMarch 1, 2013
K122925new steticNEW STETIC ARTIFICIAL TEETHFebruary 12, 2013
K122852candulor usaPHYSIOSTAR NFCDecember 6, 2012
K121749shofu dental corporationVERACIASeptember 7, 2012
K120404merz dentalMERZ DENTAL GMBH ARTEGRAL HD PREFORMED PLASTIC DENTURE TEETHMay 21, 2012
K120736ivoclar vivadentSR PHONARES IIMay 14, 2012
K113426shofu dental corporationVERACIA SAFebruary 8, 2012
K101064bredent gmbh and co. kgBREDENT NOVO.LIGN A/ BREDENT NOVO.LIGN PSeptember 14, 2010
K101029huge dental material coKAIFENG/CRYSTAL, KAILI, KAIJING, KAIYUE, MAIST AND KAITONG/ROYAL SYNTHETIC POLYMAugust 16, 2010
K093331ivoclar vivadentSR PHONARES NHCJanuary 28, 2010
K092231gebdi dental-productsGEBDI TRIBOS 501November 24, 2009
K070591union dental s.a./unidesa.odiREPLICA, ORTOLUX TOP, ODIPAL, ODILUX, ODIDENT, VITACRILIC, NATURE'S BEST, DENTALMay 11, 2007
K060720curativeCURATIVE DENTAL ACRYLIC TEETHAugust 25, 2006
K061337xpdentWIEDENT ESTETICJune 7, 2006
K060994heraeus kulzerMONDIALMay 22, 2006
K060565ivoclar vivadentCONDYLAFORM II NFCMay 8, 2006
K060507valplast intlVALPLAST YAMAHACHI TEETHApril 7, 2006
K033628heraeus kulzerARTICJanuary 16, 2004
K030588merz dentalARTEGRAL AND POLYSTAR SELECTIONMay 7, 2003

FDA data resources