Product Code: EIH


Products Classified as EIH

1187Powder, PorcelainPorcelain Powder For Clinical Use.

Total Product Life Cycle (TPLC) Devices

1187Powder, PorcelainPorcelain Powder For Clinical Use.

FDA Consensus Standards

Powder, Porcelain [32309]21 CFR §872.6660 🔎
Powder, Porcelain [31737]21 CFR §872.6660 🔎
Powder, Porcelain [33850]21 CFR §872.6660 🔎
Powder, Porcelain [38729]21 CFR §872.6660 🔎
Powder, Porcelain [33858]21 CFR §872.6660 🔎
Powder, Porcelain [38749]21 CFR §872.6660 🔎
Powder, Porcelain [38712]21 CFR §872.6660 🔎

Pre-market Notifications for EIH

K213570Dental Zirconia CeramicAidite (Qinhuangdao) Technology Co., Ltd.
K213425BruxZir EstheticPrismatik Dentalcraft, Inc.
K212259Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded BlankZirdent New Material Co., Ltd
K211916IPS E.max OneIvoclar Vivadent AG
K2108841Derful HS, 1Derful HT1Derful, Inc
K210097Estar-ZOsstem Implant Co., Ltd.
K203672MAZIC Claro CAD And MAZIC Claro PressVericom Co., Ltd.
K203590Perfit FS Dental Zirconia Fully Sintered BlockVatech Acucera, Inc.
K203499Perfit ZR ST Dental Zirconia Blank, Perfit ZR UT Dental Zirconia BlankVatech Acucera, Inc.
K202952Amber Mill Q Series & Amber Mill Direct SeriesHASS Corp.
K202673X-cera Pre-shaded Zirconia BlanksDongguan Xiangtong Co., Ltd.
K202629Dentsply Sirona Universal Spray GlazesDentsply Sirona
K201608GenesisZr UHT700 ZirconiaUnited Dental Resources Corporation
K201492Non-Sterile Zirconia BlockBioden Co., Ltd
K200131BruxZir SteelPrismatik Dentalcraft, Inc.

Global Unique Device Identification Database

00304040056639POWDER, PORCELAIN
00304040056622POWDER, PORCELAIN
00304040056615POWDER, PORCELAIN
00304040056608POWDER, PORCELAIN
00304040056592POWDER, PORCELAIN
00304040056585POWDER, PORCELAIN
00304040056578POWDER, PORCELAIN
00304040056561POWDER, PORCELAIN
00304040056554POWDER, PORCELAIN
00304040056547POWDER, PORCELAIN
00304040056530POWDER, PORCELAIN
00304040056523POWDER, PORCELAIN
00304040056516POWDER, PORCELAIN
00304040056509POWDER, PORCELAIN
00304040056493POWDER, PORCELAIN

Maude Adverse Events

IPS EMPRESS DIRECT COMPOSITEIVOCLAR VIVADENT AG2019-03-20
IPS EMPRESS DIRECT COMPOSITEIVOCLAR VIVODENT AG2019-03-20
OBSIDIAN PRESSPRISMATIK DENTALCRAFT, INC.2018-07-27
POWDER PORCELAINULTRADENT PRODUCTS2018-01-15
IPS E.MAX PRESS LTIVOCLAR VIVADENT, AG2017-09-20
DIAZIRARDENT, INC2016-10-26
CERCON BASE DISK WHITE 20 MMDENTSPLY PROSTHETICS2016-10-21
IPS EMPRESS CADIVOCLAR VIVADENT AG2016-07-01
IPS E.MAX CAD LTIVOCLAR VIVADENT AG2016-06-15
BRUXZIR BLOCKPRISMATIK DENTALCRAFT, INC.2014-08-27
LAVA ULTIMATE CROWN3M ESPE2013-12-05
LAVA ULTIMATE CROWN3M ESPE2013-12-05
LAVA ULTIMATE CROWN3M ESPE2013-12-05
LAVA ULTIMATE CROWN3M ESPE2013-12-05
LAVA ULTIMATE CROWN3M ESPE2013-12-05
DPM CENTRAL STATIONMINDRAY DS USA, INC.2013-01-29
IPS ERIS FOR E2IVOCLAR VIVADENT AG2011-05-04
CERCON CERAM KISS GLAZEDENTSPLY PROSTHETICS2008-02-22
CEREC VITABLOCVITA ZAHNFABRIK1996-07-11

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