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

K222686Perfit FS Dental Zirconia Fully Sintered BlockVatech Acucera, Inc.
K221429KDF Zirconia DiscDENKEN-HIGHDENTAL Co., Ltd.
K221242Vsmilehappyzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded BlankHunan Vsmile Biotechnology Co., Ltd
K221051Dental Zirconia Blank & Dental Zirconia Pre-Shaded BlankChangsha Honchon Technology Co., LTD
K220960BruxZir Opaque Coloring LiquidPrismatik Dentalcraft, Inc.
K220369Esthetic ColorantKuraray Noritake Dental Inc.
K220017Coloring LiquidDongguan Xiangtong Co., Ltd.
K214003Dental Zirconia Pre-shaded BlockShenzhen Yurucheng Dental Materials Co., Ltd.
K214005Zirconia Dental CeramicsShenzhen Yurucheng Dental Materials Co., Ltd.
K213570Dental Zirconia CeramicAidite (Qinhuangdao) Technology Co., Ltd.
K213425BruxZir EstheticPrismatik Dentalcraft, Inc.
K213147CERABIEN MiLaiKuraray Noritake Dental Inc.
K212939Vintage Prime PressShofu Dental Corporation
K212548LUXEN CL Dental LiquidDENTALMAX Co., Ltd.
K212259Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded BlankZirdent New Material Co., Ltd

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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