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Panels › Dental › Product code EIH · Class 2

Powder, Porcelain

Regulation 872.6660

15510(k)s in 12 months (489 all time)
1recalls in 12 months (35 all time)
35recalls that name a 510(k)
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Top companies in EIH

DateFirm and productCodeLinked 510(k)
Jun 9, 2026Sagemax Bioceramics, Inc.
NexxZr T Multi A3.5 W98-16mm, REF: 745451
Open, Classified
EIHK142233
Apr 30, 2024IVOCLAR VIVADENT AG
IPS e.max ZirCAD CER/in. Prime C2 C17/5- A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth. Article Number: 758443
Open, Classified
EIHK051705
Apr 30, 2024IVOCLAR VIVADENT AG
IPS e.max ZirCAD CER/in. Prime B1 C17/5 -A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth. Article Number: 758441
Open, Classified
EIHK051705
Apr 30, 2024IVOCLAR VIVADENT AG
IPS e.max ZirCAD CER/in. Prime A3 C17/5 -A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth Article Number: 758439
Open, Classified
EIHK051705
Apr 30, 2024IVOCLAR VIVADENT AG
IPS e.max ZirCAD CER/in. Prime A2 C17/5 -A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth. Article Number: 758438
Open, Classified
EIHK051705
Apr 30, 2024IVOCLAR VIVADENT AG
IPS e.max ZirCAD CER/in. Prime A1 C17/5 - A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth. Article Number: 758437
Open, Classified
EIHK051705
Apr 30, 2024IVOCLAR VIVADENT AG
IPS e.max ZirCAD CER/in. Prime BL1 C17/3- A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth. Article Number: 758434
Open, Classified
EIHK051705
Aug 6, 2020Talladium Inc
Talladium Luminesse Zirconia Discs, Zirconia HT Disc 98x20mm A1, Shaded Zirconia Blend 2.0 50# A1, Model No. 5147-A1;(UDI): D7915147A10 - Product Usage: are intended for CAD/CAM fabrication of all-cer
Terminated
EIHK100232
Apr 13, 2020Ivoclar Vivadent AG
Ivoclar Vivadent IPS e.max ZirCAD CER/inLab Start.Kit LT - ceramic for dental use, intended for IPS e.max ZirCAD presintered yttrium oxide-stabilized zirconium oxide blocks for the CAD/ CAM technolog
Terminated
EIHK051705
Apr 13, 2020Ivoclar Vivadent AG
Ivoclar Vivadent IPS e.max ZirCAD CER/inLab LT A3 C17/5 - ceramic for dental use, intended for IPS e.max ZirCAD presintered yttrium oxide-stabilized zirconium oxide blocks for the CAD/ CAM technology
Terminated
EIHK051705
Apr 13, 2020Ivoclar Vivadent AG
Ivoclar Vivadent IPS e.max ZirCAD CER/inLab LT A2 C17/5 - ceramic for dental use,intended for IPS e.max ZirCAD presintered yttrium oxide-stabilized zirconium oxide blocks for the CAD/ CAM technology
Terminated
EIHK051705
Apr 13, 2020Ivoclar Vivadent AG
Ivoclar Vivadent IPS e.max ZirCAD CER/inLab LT A1 C17/5 -ceramic for dental use, intended for IPS e.max ZirCAD presintered yttrium oxide-stabilized zirconium oxide blocks for the CAD/CAM technology Pr
Terminated
EIHK051705
Aug 15, 2016Prismatik Dentalcraft, Inc
BruxZir Shaded, Model No. 70-1167-NOW0001, 70-1167-NOW0002, 70-1167-NOW0003, 70-1167-NOW0005, 70-1167-NOW0006 The device is indicated for use by dental technicians in the construction of custom made
Terminated
EIHK130924
May 27, 2016Ivoclar Vivadent, Inc.
Zenostar MT Color Impulse orange, art. no. 681168. Product Usage: For coloring dental porcelain
Terminated
EIHK152118
May 27, 2016Ivoclar Vivadent, Inc.
Zenostar MT Color D4 60ml, art. no. 681065. Product Usage: For coloring dental porcelain
Terminated
EIHK152118
May 27, 2016Ivoclar Vivadent, Inc.
Zenostar MT Color D3 60ml, art. no. 681064. Product Usage: For coloring dental porcelain
Terminated
EIHK152118
May 27, 2016Ivoclar Vivadent, Inc.
Zenostar MT Color D2 60ml, art. no. 681063. Product Usage: For coloring dental porcelain
Terminated
EIHK152118
May 27, 2016Ivoclar Vivadent, Inc.
Zenostar MT Color C4 60ml, art. no. 681062. Product Usage: For coloring dental porcelain
Terminated
EIHK152118
May 27, 2016Ivoclar Vivadent, Inc.
Zenostar MT Color C3 60ml, art. no. 681061. Product Usage: For coloring dental porcelain
Terminated
EIHK152118
May 27, 2016Ivoclar Vivadent, Inc.
Zenostar MT Color C2 60ml art. no. 681060. Product Usage: For coloring dental porcelain
Terminated
EIHK152118
May 27, 2016Ivoclar Vivadent, Inc.
Zenostar MT Color C1 60ml, art. no. 681059. Product Usage: For coloring dental porcelain
Terminated
EIHK152118
May 27, 2016Ivoclar Vivadent, Inc.
Zenostar MT Color B4 60ml, art. no. 681058. Product Usage: For coloring dental porcelain
Terminated
EIHK152118
May 27, 2016Ivoclar Vivadent, Inc.
Zenostar MT Color B3 60ml, art. no. 681057. Product Usage: For coloring dental porcelain
Terminated
EIHK152118
May 27, 2016Ivoclar Vivadent, Inc.
Zenostar MT Color B2 60ml, art. no. 681056. Product Usage: For coloring dental porcelain
Terminated
EIHK152118
May 27, 2016Ivoclar Vivadent, Inc.
Zenostar MT Color B1 60ml, art. no. 681055. Product Usage: For coloring dental porcelain
Terminated
EIHK152118
May 27, 2016Ivoclar Vivadent, Inc.
Zenostar MT Color A4 60ml, art. no. 681054. Product Usage: For coloring dental porcelain
Terminated
EIHK152118
May 27, 2016Ivoclar Vivadent, Inc.
Zenostar MT Color A3.5 60ml, art. no. 681053. Product Usage: For coloring dental porcelain
Terminated
EIHK152118
May 27, 2016Ivoclar Vivadent, Inc.
Zenostar MT Color A3 60ml, art. no. 681052. Product Usage: For coloring dental porcelain
Terminated
EIHK152118
May 27, 2016Ivoclar Vivadent, Inc.
Zenostar MT Color A2 60ml, art. no. 681051. Product Usage: For coloring dental porcelain
Terminated
EIHK152118
May 27, 2016Ivoclar Vivadent, Inc.
Zenostar MT Color A1 60ml, art. no. 681050, Product Usage: For coloring dental porcelain
Terminated
EIHK152118
May 27, 2016Ivoclar Vivadent, Inc.
Zenostar MT Color Impulse violet, art. no. 681166 Product Usage: For coloring dental porcelain
Terminated
EIHK152118
May 27, 2016Ivoclar Vivadent, Inc.
Zenostar MT Color Impulse grey, art. no. 681167 Product Usage: For coloring dental porcelain
Terminated
EIHK152118
May 27, 2016Ivoclar Vivadent, Inc.
Zenostar MT Color Impulse brown, art. no. 681169 Product Usage: For coloring dental porcelain
Terminated
EIHK152118
May 27, 2016Ivoclar Vivadent, Inc.
Zenostar MT Color Impulse blue, Art. no. 681165 Product Usage: For coloring dental porcelain
Terminated
EIHK152118
Jul 27, 2015Ivoclar Vivadent, Inc.
IPS Empress Universal Glaze Spray 270 mL, Product Code/Model/Catalog Number 609432AN, Rx only. Porcelain glaze spray used in the fabrication of dental restorations
Terminated
EIHK012174

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