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 |
|---|---|---|---|
| Aug 4, 2017 | K163251 | Life Essence Universal Porcelain System Blue Sky Bio | EIH |
| Aug 1, 2017 | K170894 | Zirconia Dental Ceramics Chengdu Besmile Biotechnology Co., Ltd., CN | EIH |
| Aug 1, 2017 | K170885 | DD cubeX2 HS Dental Direkt GmbH, DE | EIH |
| Jul 13, 2017 | K170986 | KATANA Zirconia Block Kuraray Noritake Dental, Inc., JP | EIH |
| Jun 5, 2017 | K163228 | APVolution System Aesthetic-Press, LLC | EIH |
| May 4, 2017 | K163238 | Eclipse Kiss Zirconia Ams, KR | EIH |
| Mar 2, 2017 | K170420 | n!ce Glass Ceramic Blocks for Amann Girrbach Institut Straumann AG, CH | EIH |
| Feb 24, 2017 | K162888 | Cercon Dentsply Sirona | EIH |
| Feb 3, 2017 | K161025 | priti multidisc ZrO2 High Translucent Pritidenta GmbH, DE | EIH |
| Jan 26, 2017 | K161219 | Zmaxx T Series Maxx Digm, Inc. | EIH |
| Dec 21, 2016 | K162677 | L- OVC Rhondium, Ltd., NZ | EIH |
| Nov 10, 2016 | K160079 | rainbow Shine Genoss Co., Ltd., KR | EIH |
| Oct 19, 2016 | K160203 | ADAMANT ZIRCONIA DISC Adamant Co., Ltd., JP | EIH |
| Sep 16, 2016 | K160262 | n!ce LT Glass Ceramic Blocks, n!ce HT Glass Ceramic Blocks, Institut Straumann AG, CH | EIH |
| Sep 15, 2016 | K152023 | Luminesse Shaded Zirconia SZ Talladium, Inc. | EIH |
| Sep 13, 2016 | K153130 | Initial LiSi Block GC America, Inc. | EIH |
| Sep 12, 2016 | K160867 | Pavati Z40.2 Zirconia Ccri, Inc. | EIH |
| Sep 1, 2016 | K161922 | XP202 3M Deutschland GmbH, DE | EIH |
| Aug 12, 2016 | K161269 | CELTRA Press Dentsply Sirona | EIH |
| Jul 27, 2016 | K160367 | Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank Nissin-Metec China Co., Ltd., CN | EIH |
| Jul 21, 2016 | K160144 | rainbow LS Block Genoss Co., Ltd., KR | EIH |
| Jul 14, 2016 | K160102 | Amber Mill Series and Amber Press Series Hass Corp., KR | EIH |
| Jun 30, 2016 | K153136 | Initial LiSi Press GC America, Inc. | EIH |
| Jun 2, 2016 | K160099 | CEREC SpeedGlaze Sirona Dental Systems GmbH, DE | EIH |
| May 20, 2016 | K152103 | IPS Style Ceram, IPS Style Ceram One, IPS Style Press Ivoclar Vivadent, AG, LI | EIH |
| Apr 15, 2016 | K151731 | Rainbow Paste Stain Genoss, KR | EIH |
| Mar 29, 2016 | K153767 | X-cera Zirconia Blanks Shenzhen Xiangtong Photoelectricity Technology Co., Ltd., CN | EIH |
| Mar 25, 2016 | K152274 | MSCB-001 GC America, Inc. | EIH |
| Jan 29, 2016 | K152247 | ATLANTIS Crown Dentsply International, Inc. | EIH |
| Jan 14, 2016 | K151846 | Rainbow LS Pressing Genoss, KR | EIH |
| Jan 14, 2016 | K151842 | Rainbow Shine Genoss, KR | EIH |
| Jan 8, 2016 | K152392 | VINTAGE LD Shofu Dental Corporation | EIH |
| Dec 16, 2015 | K152118 | Zenostar MT, Zenostar Color Liquids Wieland Dental + Technik GmbH & Co. KG, DE | EIH |
| Dec 11, 2015 | K152451 | VINTAGE Art LF Shofu Dental Corporation | EIH |
| Dec 4, 2015 | K152175 | Upcera Dental Zirconia Blank for Aesthetic Restoration Liaoning Upcera Co., Ltd., CN | EIH |
| Oct 29, 2015 | K151894 | IPS Ivocolor Ivoclar Vivadent, AG, LI | EIH |
| Oct 29, 2015 | K151875 | Pavati Zirconia Ccri, Inc. | EIH |
| Oct 28, 2015 | K151723 | Rainbow Trans Genoss, KR | EIH |
| Oct 21, 2015 | K152066 | Luminesse Anterior Zirconia AT Talladium, Inc. | EIH |
| Oct 16, 2015 | K151844 | Rainbow Shade Genoss, KR | EIH |
| Oct 8, 2015 | K151490 | PRETTAU ANTERIOR T0 Zirkonzahn GmbH, IT | EIH |
| Sep 21, 2015 | K152383 | Ceramill Zolid FX Emergo Europe Consulting, NL | EIH |
| Jul 13, 2015 | K150919 | ArgenZ Esthetic Plus The Argen Corporation | EIH |
| Jul 9, 2015 | K143656 | StarCeram® Z-Nature, StarCeram® Z-Smile H.C. Starck Ceramics GmbH, DE | EIH |
| Jul 2, 2015 | K150872 | BruxZir Anterior Milling Blanks Prismatik Dentalcraft, Inc. | EIH |
| Jun 26, 2015 | K143071 | Nacera Pearl Doceram Medical Ceramics GmbH, DE | EIH |
| Jun 17, 2015 | K140836 | ZIBONE ZIRCONIA BLOCKS Coho Technology Co., Ltd., TW | EIH |
| Jun 15, 2015 | K143090 | LUMINESSE PRE-SINTERED ZIRCONIA COLORING LIQUID Talladium, Inc. | EIH |
| May 20, 2015 | K140491 | TANAKA ZIRCOLOR COLORING LIQUID, TANAKA ZIRCOLOR DIPPING LIQUID AND TANAKA ENAMEL ZR BLOCKS Tanaka Dental | EIH |
| May 6, 2015 | K150056 | Luxisse+ Heany Industries, Inc. | EIH |
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