Powder, Porcelain
Regulation 872.6660
17510(k)s in 12 months (491 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 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 10, 2021 | K201492 | Non-Sterile Zirconia Block Bioden Co., Ltd., KR | EIH |
| Mar 8, 2021 | K203351 | Perfit ZR HT Dental Zirconia blank Vatech Acucera, Inc., KR | EIH |
| Feb 23, 2021 | K201915 | GenesisZr 4Y+ (ST1100) Zirconia United Dental Resources Corporation | EIH |
| Jan 28, 2021 | K201608 | GenesisZr UHT700 Zirconia United Dental Resources Corporation | EIH |
| Jan 20, 2021 | K202629 | Dentsply Sirona Universal Spray Glazes Dentsply Sirona | EIH |
| Dec 10, 2020 | K202673 | X-cera Pre-shaded Zirconia Blanks Dongguan Xiangtong Co., Ltd., CN | EIH |
| Oct 29, 2020 | K193090 | HCG Zirconia Ceramic Block Hocheng Corporation, TW | EIH |
| Aug 18, 2020 | K192723 | Coloring Liquid Aidite (Qinhuangdao) Technology Co., Ltd., CN | EIH |
| Jul 21, 2020 | K193434 | VITA LUMEX AC Vita Zahnfabrik GmbH H Rauter & CO, DE | EIH |
| Jul 8, 2020 | K192231 | Dental Glass Ceramics Blocks Aidite (Qinhuangdao) Technology Co., Ltd., CN | EIH |
| Jun 10, 2020 | K200131 | BruxZir Steel Prismatik Dentalcraft, Inc. | EIH |
| May 29, 2020 | K192262 | Dental Zirconia Blocks De Corematrix Co., Ltd., CN | EIH |
| May 14, 2020 | K193436 | VITA Ambria Vita Zahnfabrik GmbH H Rauter & CO, DE | EIH |
| May 13, 2020 | K193055 | Purzir Dental Zirconia 3DBiocad | EIH |
| Apr 16, 2020 | K193588 | DD Contrast Dental Direkt GmbH, DE | EIH |
| Jan 31, 2020 | K192535 | Unshaded Dental Zirconia and Pre-Shaded Dental Zirconia Qinhuangdao Audental Metal Technology Co., Ltd., CN | EIH |
| Jan 30, 2020 | K193060 | Noritake Super Porcelain EX-3 Kuraray Noritake Dental, Inc., JP | EIH |
| Jan 15, 2020 | K192251 | Livento Press, Soprano 10, Soprano Cendres+Metaux SA, CH | EIH |
| Dec 20, 2019 | K190112 | Non-Sterile Zirconia Block Fine Advanced Compound Co., Ltd., KR | EIH |
| Nov 22, 2019 | K191903 | BruxZir GT (Gum Tissue) Color Prismatik Dentalcraft, Inc. | EIH |
| Nov 22, 2019 | K190518 | Color Liquid, Vita Liquid Zirkonzahn Srl, IT | EIH |
| Nov 4, 2019 | K191304 | EthanZir Zirconia Besorah Dental Solutions NZ Limited, NZ | EIH |
| Nov 1, 2019 | K191631 | ZMAXX Dental Zirconia Blanks Zmaxx Bioceramics, LLC | EIH |
| Oct 11, 2019 | K191902 | Razor, Everest, U&C Liquid U&C International Co., Ltd., KR | EIH |
| Oct 3, 2019 | K191794 | Vintage Art Universal Shofu Dental Corporation | EIH |
| Jul 29, 2019 | K190569 | Shaders ZR Digital Age Dental Lab | EIH |
| May 23, 2019 | K190436 | KATANA Zirconia Block Kuraray Noritake Dental, Inc., JP | EIH |
| May 22, 2019 | K182350 | Dental Ceramic Baot Biological Technology Co., Ltd., CN | EIH |
| Apr 12, 2019 | K190079 | ArgenZ HT+ The Argen Corporation | EIH |
| Apr 4, 2019 | K183304 | Prettau, ICE, Z-White zirconia blanks Zirkonzahn Srl, IT | EIH |
| Mar 20, 2019 | K183408 | Jensen Shade Effect Liquids Jensen Industries, Inc. | EIH |
| Feb 14, 2019 | K183569 | DD cube ONE ML Dental Direkt GmbH, DE | EIH |
| Feb 8, 2019 | K182833 | ArgenZ Liquid Shade, ArgenZ Incisal Effect, ArgenZ Color Modifier, ArgenZ Pontic Reducer The Argen Corporation | EIH |
| Jan 25, 2019 | K182642 | GenesisZr 4Y Zirconia United Dental Resources Corporation | EIH |
| Dec 18, 2018 | K181496 | VINTAGE PRO Shofu Dental Corporation | EIH |
| Dec 13, 2018 | K182068 | Erran Dental Zirconia Hangzhou Erran Technology Co., Ltd., CN | EIH |
| Nov 29, 2018 | K181816 | Ceramic Denture Zirconia Ceramics Block Qinhuangdao Silide Ceramic Technology Co., Ltd., CN | EIH |
| Nov 15, 2018 | K173971 | K2 Zirkon Blank white classic; K2 Zirkon Blank translucent; K2 Blanks extreme translucent Yeti Dentalprodukte GmbH, DE | EIH |
| Oct 31, 2018 | K171585 | LUXEN Zr, LUXEN Smile Dentalmax Co., Ltd., KR | EIH |
| Sep 2, 2018 | K181167 | Upcera Glaze Paste, Glaze Powder, and Glaze Liquid Liaoning Upcera Co., Ltd., CN | EIH |
| Aug 23, 2018 | K170050 | Z-CAD smile Metoxit AG, CH | EIH |
| Aug 1, 2018 | K180703 | VITA YZ ST and VITA YZ XT Vita Zahnfabrik H.Rauter GmbH Co., DE | EIH |
| Apr 24, 2018 | K180252 | Crown Dental Zirconia Blank & Crown Dental Zirconia Pre-Shaded Blank Crown Porcelain Dental Technology Co., Ltd., CN | EIH |
| Mar 8, 2018 | K173769 | DMAX Coloring Liquid; Chang's Liquid; Confident Coloring Liquid; CAMeleon Coloring Liquid Dmax Co., Ltd., KR | EIH |
| Dec 13, 2017 | K171167 | Prodigio Stain Powder Operart, LLC | EIH |
| Nov 28, 2017 | K161652 | DIAZIR Zxtgy (Beijing) Technology Co., Ltd., CN | EIH |
| Nov 17, 2017 | K172761 | New Century All-Ceramic Dental Zirconia Blocks (Un-Shaded & Pre-Shaded) Shanghai New Century Dental Materials Co., Ltd., CN | EIH |
| Nov 14, 2017 | K173410 | n!ce for Planmill Institut Straumann AG, CH | EIH |
| Oct 17, 2017 | K170834 | CERABIEN ZR Kuraray Noritake Dental, Inc., JP | EIH |
| Sep 20, 2017 | K171876 | Ceramill Zolid HT+ white Amann Girrbach AG, AT | EIH |
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