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)
Top companies in EIH
| Company | 510(k)s | Recalls |
|---|---|---|
| Ivoclar Vivadent, AG | 9 | 32 |
| Dentsply Intl. | 23 | 0 |
| Prismatik Dentalcraft, Inc. | 21 | 1 |
| Vident | 16 | 0 |
| Shofu Dental Corp. | 15 | 0 |
| Noritake Co., Inc. | 14 | 0 |
| Wieland Dental + Technik GmbH & Co. KG | 14 | 0 |
| Jensen Industries, Inc. | 11 | 0 |
| Kuraray Noritake Dental, Inc. | 11 | 0 |
| Genoss | 10 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 9, 2026 | Sagemax Bioceramics, Inc. NexxZr T Multi A3.5 W98-16mm, REF: 745451 Open, Classified |
EIH | K142233 |
| Apr 30, 2024 | IVOCLAR 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 |
EIH | K051705 |
| Apr 30, 2024 | IVOCLAR 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 |
EIH | K051705 |
| Apr 30, 2024 | IVOCLAR 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 |
EIH | K051705 |
| Apr 30, 2024 | IVOCLAR 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 |
EIH | K051705 |
| Apr 30, 2024 | IVOCLAR 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 |
EIH | K051705 |
| Apr 30, 2024 | IVOCLAR 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 |
EIH | K051705 |
| Aug 6, 2020 | Talladium 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 |
EIH | K100232 |
| Apr 13, 2020 | Ivoclar 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 |
EIH | K051705 |
| Apr 13, 2020 | Ivoclar 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 |
EIH | K051705 |
| Apr 13, 2020 | Ivoclar 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 |
EIH | K051705 |
| Apr 13, 2020 | Ivoclar 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 |
EIH | K051705 |
| Aug 15, 2016 | Prismatik 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 |
EIH | K130924 |
| May 27, 2016 | Ivoclar Vivadent, Inc. Zenostar MT Color Impulse orange, art. no. 681168.
Product Usage:
For coloring dental porcelain Terminated |
EIH | K152118 |
| May 27, 2016 | Ivoclar Vivadent, Inc. Zenostar MT Color D4 60ml, art. no. 681065.
Product Usage:
For coloring dental porcelain Terminated |
EIH | K152118 |
| May 27, 2016 | Ivoclar Vivadent, Inc. Zenostar MT Color D3 60ml, art. no. 681064.
Product Usage:
For coloring dental porcelain Terminated |
EIH | K152118 |
| May 27, 2016 | Ivoclar Vivadent, Inc. Zenostar MT Color D2 60ml, art. no. 681063.
Product Usage:
For coloring dental porcelain Terminated |
EIH | K152118 |
| May 27, 2016 | Ivoclar Vivadent, Inc. Zenostar MT Color C4 60ml, art. no. 681062.
Product Usage:
For coloring dental porcelain Terminated |
EIH | K152118 |
| May 27, 2016 | Ivoclar Vivadent, Inc. Zenostar MT Color C3 60ml, art. no. 681061.
Product Usage:
For coloring dental porcelain Terminated |
EIH | K152118 |
| May 27, 2016 | Ivoclar Vivadent, Inc. Zenostar MT Color C2 60ml art. no. 681060.
Product Usage:
For coloring dental porcelain Terminated |
EIH | K152118 |
| May 27, 2016 | Ivoclar Vivadent, Inc. Zenostar MT Color C1 60ml, art. no. 681059.
Product Usage:
For coloring dental porcelain Terminated |
EIH | K152118 |
| May 27, 2016 | Ivoclar Vivadent, Inc. Zenostar MT Color B4 60ml, art. no. 681058.
Product Usage:
For coloring dental porcelain Terminated |
EIH | K152118 |
| May 27, 2016 | Ivoclar Vivadent, Inc. Zenostar MT Color B3 60ml, art. no. 681057.
Product Usage:
For coloring dental porcelain Terminated |
EIH | K152118 |
| May 27, 2016 | Ivoclar Vivadent, Inc. Zenostar MT Color B2 60ml, art. no. 681056.
Product Usage:
For coloring dental porcelain Terminated |
EIH | K152118 |
| May 27, 2016 | Ivoclar Vivadent, Inc. Zenostar MT Color B1 60ml, art. no. 681055.
Product Usage:
For coloring dental porcelain Terminated |
EIH | K152118 |
| May 27, 2016 | Ivoclar Vivadent, Inc. Zenostar MT Color A4 60ml, art. no. 681054.
Product Usage:
For coloring dental porcelain Terminated |
EIH | K152118 |
| May 27, 2016 | Ivoclar Vivadent, Inc. Zenostar MT Color A3.5 60ml, art. no. 681053.
Product Usage:
For coloring dental porcelain Terminated |
EIH | K152118 |
| May 27, 2016 | Ivoclar Vivadent, Inc. Zenostar MT Color A3 60ml, art. no. 681052.
Product Usage:
For coloring dental porcelain Terminated |
EIH | K152118 |
| May 27, 2016 | Ivoclar Vivadent, Inc. Zenostar MT Color A2 60ml, art. no. 681051.
Product Usage:
For coloring dental porcelain Terminated |
EIH | K152118 |
| May 27, 2016 | Ivoclar Vivadent, Inc. Zenostar MT Color A1 60ml, art. no. 681050,
Product Usage:
For coloring dental porcelain Terminated |
EIH | K152118 |
| May 27, 2016 | Ivoclar Vivadent, Inc. Zenostar MT Color Impulse violet, art. no. 681166
Product Usage:
For coloring dental porcelain Terminated |
EIH | K152118 |
| May 27, 2016 | Ivoclar Vivadent, Inc. Zenostar MT Color Impulse grey, art. no. 681167
Product Usage:
For coloring dental porcelain Terminated |
EIH | K152118 |
| May 27, 2016 | Ivoclar Vivadent, Inc. Zenostar MT Color Impulse brown, art. no. 681169
Product Usage:
For coloring dental porcelain Terminated |
EIH | K152118 |
| May 27, 2016 | Ivoclar Vivadent, Inc. Zenostar MT Color Impulse blue, Art. no. 681165
Product Usage:
For coloring dental porcelain Terminated |
EIH | K152118 |
| Jul 27, 2015 | Ivoclar 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 |
EIH | K012174 |
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