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Powder, Porcelain
FDA product code EIH · Class 2 · Dental
0
Registered devices
51
Adverse events
35
Recalls
487
510(k) clearances
Devices with this code
Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank — NISSIN METEC CHINA CO.,LTD.NexxZr™ T / Z-95-18-NT-B100-SD — SAGEMAX BIOCERAMICS, INCIPS e.max ZirCAD — IVOCLAR VIVADENT AKTIENGESELLSCHAFTpriti perfect — Estetic Ceram AGIPS e.max CAD — IVOCLAR VIVADENT AKTIENGESELLSCHAFTNacera — DOCERAM medical ceramics GmbHGC Initial™ — Gc America Inc.VINTAGE Art Universal — SHOFU DENTAL CORPORATIONCERABIEN™ ZR — KURARAY NORITAKE DENTAL INC.Cameo — Aidite (Qinhuangdao) Technology Co., Ltd.GC Initial™ — Gc America Inc.Zirlux — HENRY SCHEIN, INC.Delta Zirconia High Translucent Disc — AURIDENT INCBloomden — Bloomden Bioceramics (Hunan) Co., Ltd.Cercon® — DeguDent GmbHDD Bio ZX² — Dental Direkt GmbHNacera — DOCERAM medical ceramics GmbHupcera Dental Zirconia Blank for Aesthetic Restoration — Liaoning Upcera Co.,Ltd.Aidite — Aidite (Qinhuangdao) Technology Co., Ltd.Dental Lithium Disilicate Glass Ceramic — Liaoning Rachcera Material Technology Co.,Ltd.ceraMotion® — DENTAURUM GmbH & Co.KGVITA PM9 — Vita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co KommanditgesellschaftVITA ENAMIC — Vita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co KommanditgesellschaftLUXEN 5G — DENTALMAX CO.,LTD
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-12-11 | Sagemax Bioceramics, Inc. | Yttrium-stabilized zirconium oxide discs for fixed all-ceramic dental restorations may have reduced or missing dentin layer and when used clinically in the pat |
| 2024-04-05 | IVOCLAR VIVADENT AG | Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration |
| 2024-04-05 | IVOCLAR VIVADENT AG | Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration |
| 2024-04-05 | IVOCLAR VIVADENT AG | Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration |
| 2024-04-05 | IVOCLAR VIVADENT AG | Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration |
| 2024-04-05 | IVOCLAR VIVADENT AG | Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration |
| 2024-04-05 | IVOCLAR VIVADENT AG | Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration |
| 2020-08-06 | Talladium Inc | The linear shrinkage on the zirconia blank disc s part label is incorrect. The average linear shrinkage found on the product label was outside the acceptable ra |
| 2020-04-13 | Ivoclar Vivadent AG | Restorations crack during the sintering process. |
| 2020-04-13 | Ivoclar Vivadent AG | Restorations crack during the sintering process. |
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