Powder, Porcelain
Dental · 21 CFR 872.6660
Recent MDR events
51 adverse event reports on file
- BRUXZIR SHADED 16 PLUSJun 8, 2026InjuryPrismatik Dentalcraft, Inc.3011649314-2026-00876
- Cercon yo ML A3 disk 98 18Mar 31, 2026InjuryDegudent Gmbh9681199-2026-00001
- Cercon yo ML A2 disk 98 18Mar 31, 2026InjuryDegudent Gmbh9681199-2026-00002
- BRUXZIR SCREW RETAINED CROWNMar 3, 2025InjuryPrismatik Dentalcraft, Inc.3011649314-2025-00173
- BRUXZIR ESTHETIC NOW SHADE A1Nov 12, 2024MalfunctionPrismatik Dentalcraft, Inc.3011649314-2024-00880
- OBSIDIAN BLOCK A2 MILLING BLOCKSOct 31, 2024MalfunctionPrismatik Dentalcraft, Inc.3011649314-2024-00846
- OBSIDIAN BLOCK A2 MILLING BLOCKSOct 31, 2024MalfunctionPrismatik Dentalcraft, Inc.3011649314-2024-00848
- OBSIDIAN BLOCK A2 MILLING BLOCKSOct 31, 2024MalfunctionPrismatik Dentalcraft, Inc.3011649314-2024-00847
- DS UNIV STAIN & OVERGLAZE KITJul 5, 2024InjuryDentsply Llc2424472-2024-00383
- 3D PRINTED ZIRCONIUM CROWNApr 3, 2024InjuryUnkMW5153519
Event type breakdown
Recalls
35 recall events for this product code
- Sagemax Bioceramics, Inc.Open, ClassifiedJun 9, 2026
NexxZr T Multi A3.5 W98-16mm, REF: 745451
Yttrium-stabilized zirconium oxide discs for fixed all-ceramic dental restorations may have reduced or missing dentin layer and when used clinically in the patient's mouth there is an increased risk of fractures under functional stress.
Z-2356-2026 · View FDA record ↗ - IVOCLAR VIVADENT AGOpen, ClassifiedApr 30, 2024
IPS e.max ZirCAD CER/in. Prime BL1 C17/3- A zirconium oxide block for the fabrication of
Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration
Z-1703-2024 · View FDA record ↗ - IVOCLAR VIVADENT AGOpen, ClassifiedApr 30, 2024
IPS e.max ZirCAD CER/in. Prime A1 C17/5 - A zirconium oxide block for the fabrication of
Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration
Z-1704-2024 · View FDA record ↗ - IVOCLAR VIVADENT AGOpen, ClassifiedApr 30, 2024
IPS e.max ZirCAD CER/in. Prime A2 C17/5 -A zirconium oxide block for the fabrication of
Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration
Z-1705-2024 · View FDA record ↗ - IVOCLAR VIVADENT AGOpen, ClassifiedApr 30, 2024
IPS e.max ZirCAD CER/in. Prime A3 C17/5 -A zirconium oxide block for the fabrication of
Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration
Z-1706-2024 · View FDA record ↗ - IVOCLAR VIVADENT AGOpen, ClassifiedApr 30, 2024
IPS e.max ZirCAD CER/in. Prime B1 C17/5 -A zirconium oxide block for the fabrication of
Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration
Z-1707-2024 · View FDA record ↗ - IVOCLAR VIVADENT AGOpen, ClassifiedApr 30, 2024
IPS e.max ZirCAD CER/in. Prime C2 C17/5- A zirconium oxide block for the fabrication of
Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration
Z-1708-2024 · View FDA record ↗ - Ivoclar Vivadent, Inc.TerminatedJul 27, 2015
IPS Empress Universal Glaze Spray 270 mL, Product Code/Model/Catalog Number 609432AN, Rx only. Porcelain glaze spray used in the fabrication of dental restora
Complaints were received of coarse particles in the glazed surface of IPS e.max Ceram restorations. A basic component of the glass contains a higher number of large grain sizes than usual.
Z-2265-2015 · View FDA record ↗ - Ivoclar Vivadent, Inc.TerminatedUnknown
Zenostar MT Color Impulse blue, Art. no. 681165
The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.
Z-0017-2017 · View FDA record ↗ - Ivoclar Vivadent, Inc.TerminatedUnknown
Zenostar MT Color Impulse brown, art. no. 681169
The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.
Z-0018-2017 · View FDA record ↗
Registered firms
581 firms currently registered for this product code
Gc Corporation-fuji Oyama Factory
SUNTO-GUN, Shizuoka-Ken, JP
Prismatik Dentalcraft, Inc.
Irvine, CA, US
Primotec Llc
Norwalk, CT, US
Digital Age Dental Laboratories, Ltd.
Vinh Tan Ward Ho Chi Minh, VN
Solventum Us Llc
San Antonio, TX, US
Cao Group, Inc.
W Jordan, UT, US
Straumann Manufacturing, Inc.
Mansfield, TX, US
Ivoclar Vivadent Manufacturing, Inc
Somerset, NJ, US
Dentaurum Gmbh & Co. Kg
ISPRINGEN Baden-Wurttemberg, DE
Shenzhen Upcera Digital Dental Technology Co., Ltd
Shenzhen Guangdong, CN
Talladium, Inc.
Santa Clarita, CA, US
Monde Dental Lab
Shenzhen Guangdong, CN
Synergy Health Ast, Srl
Alajuela, CR
Institut Straumann Ag
BASEL Basel-Stadt, CH
Dentsply Ih Bv
Sevenum Limburg, NL
Ivoclar Vivadent Manufacturing Gmbh
NATURNO (BZ) Bolzano, IT
Shenzhen Xiangtong Co., Ltd.
Shenzhen Guangdong, CN
Genoss Co., Ltd.
Suwon-si Gyeonggi, KR
Imagine Milling Technologies, Llc
Milford, NH, US
Zirkonzahn Srl
Gais Bolzano, IT
510(k) clearances
486 clearances for this product code
- Prismatik Dentalcraft, Inc.Jul 30, 2026
K262239 · Obsidian® Press Over Zirconia
- Hunan Qinghao Puzhong Technology Co., Ltd.Jul 17, 2026
K261046 · Dental Zirconia Blank & Coloring Liquid
- Zima International Inc., dba DandyJun 30, 2026
K262195 · Dandy Ceramic Stain and Glaze
- Amann Girrbach AGJun 29, 2026
K260918 · Zolid Lunaris
- Hass Corp.Jun 11, 2026
K260859 · Rosetta SM, Rosetta SP
- Dental Creativ Management GmbHMay 21, 2026
K253191 · DCMhotbond zircon
- Shandong Huge Dental Material CorporationApr 9, 2026
K260067 · Eternal Art Porcelain Powders
- Bloomden Bioceramics (HuNan) Co., Ltd.Mar 30, 2026
K260370 · Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank