Prosthetic devices · 21 CFR 872 Subpart D

Posterior with Metal Insert Artificial Teeth

FDA device type “Teeth, Artificial, Posterior With Metal Insert”.

FDA codeELJClass121 CFR872.3900Pathway510(k) exempt
Companies listing it
4232 makers
Brands and models
72
510(k) clearances
00 in five years
FDA name
Teeth, Artificial, Posterior With Metal Insert

Companies that list ELJ

42 companies currently list this device type with FDA.

CompanyCountryRoleBrands and models listedClearancesLatest
Ray Co., Ltd,South KoreaMakerRAYDENT C&B212026
Vericom Co., Ltd.South KoreaMaker—202026
Vertex-Dental B.V.NetherlandsMakerCeramill C&B MFH · E-Dent 400 · NextDent C&B · NextDent C&B MFH72024
DIO CorporationSouth KoreaMakerDIOnavi-C&B · DIOnavi-C&B F · DIOnavi-C&B Z · DIOnavi-High C&B · +2142023
Hangzhou Thales Medtech Co., Ltd.ChinaMakerZirconia Restoration12024
ZOGEAR Medical Co., Ltd.ChinaMakerTEETH, ARTIFICIAL, POSTERIOR WITH METAL INSERT——
Nanjing Chamlion Laser Technology Co., Ltd.ChinaMakerRPD Metal Framework——
one day dental partnerSouth KoreaMakerkage TEETH, ARTIFICIAL, POSTERIOR WITH METAL INSERT——
Improve Co.,limitedHong Kong SAR ChinaMakerarylic denture · E.max crown/bridge · E.max crown/bridge, Valplast · metal framework denture · +4——
Aurum Group Ltd.CanadaMakerDENTAL PROSTHESIS——
HyperCert LimitedUnited StatesMakerarylic dentures · E.max crown/bridge · metal framework dentures · Porcelain fused to metal crown/bridges · +2——
China Dental Outsourcing IncChinaMakerPOSTERIOR WITH METAL——
Dxin Trading HK Co., LimitedChinaMakerarylic dentures · E.max crown/bridge · metal framework dentures · Porcelain fused to metal crown/bridges · +2——
Huile Denture Technology (Hong Kong) Co LimitedChinaMakerarylic dentures · E.max crown/bridge · metal framework dentures · Porcelain fused to metal crown/bridges · +2——
Nam A Dental Medicine Company LimitedVietnamMakerAll Ceramic Prosthesis · Implant-Supported Prosthesis · Porcelain-Fused-to-Metal Prosthesis——
SMD Dental LaboratorySouth KoreaMakerTEETH, ARTIFICIAL, POSTERIOR WITH METAL INSERT——
Cometech VN Company LimitedVietnamMakerCOMETECH VN——
Shenzhen HLD Dental&Technology Co.,LtdChinaMakerHeraeus; Argen; Vita; Ceramic; Ivoclar——
Shenzhen Times Dental LabChinaMakerTimes Dental Custom Restorations——
Smile Dental Laboratory Company LimitedChinaMakerPARTIAL DENTURE——
Arak Dental LabUnited Arab EmiratesMakerArtificial teeth——
Innovaid Co.South KoreaMakerTeeth, Artificial, With Metal Insert——
Istar dental labChinaMakerPorcelain Fused To Metal Crown/Bridge; Zirconia Crown/Bridge; Emax Crown/Bridge: Anterior and Posterior——
Shanghai dental labs INC.ChinaMakerPosterior artificial tooth with a metal insert——
Sunrise Dental Laboratory, Ltd.Hong Kong SAR ChinaMakerPOSTERIOR WITH METAL INSERT#DENTAL——
Integrity Dental Services LLCUnited StatesMakerTeeth, Artificial, Posterior With Metal Insert——
Rite Smile LabsChinaMakerArtificial teeth, partial acrylic——
Wellstone Dental LLCUnited StatesMakerWELLSTONE Crown & Bridge · WELLSTONE Dental Prosthesis · WELLSTONE Lab Products——
Crown MakersSouth KoreaMakerCM-202402——
Perfect crown dental labUnited StatesMakerTEETH, ARTIFICIAL, ACRYLIC——
Aurum Classic Ltd.CanadaMaker———
Sunstar Trading International LimitedChinaMaker———
Imagine Milling Technologies, LLCUnited StatesContract manufacturerE-Dent 400; NextDent C&B; NextDent C&B MFH42026
Amann Girrbach AGAustriaForeign exporter—32026
Dentimed Sao Joao LLCUnited StatesRepacker / relabelerORTHOM——
Ray America Inc.United StatesListerRAYDENT C&B——
Hager & WerkenGermanyContract manufacturerOCCLU PRINT——
DigiSmiles LabUnited StatesRepacker / relabelerTeeth, Artificial, POSTERIOR with Metal Insert——
Damore Dental Lab LLCUnited StatesRepacker / relabelercrown——
Fire Dental Studio, LLCUnited StatesRepacker / relabelerFIRE ELJ Teeth, Artificial, posterior with metal insert——
Kelsey Dental LLCUnited StatesSpecification developerarylic dentures; E.max crown/bridge; metal framework dentures; Porcelain fused to metal crown/bridges; Valplast; zirconi——
Gregory Weil Dental Ceramic Studio, Inc.United StatesRepacker / relabelerMetal Insert For Dental Prosthetic——

Official records: FDA product classification for ELJ · 21 CFR 872.3900.

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026