Home › Device types › EIH
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
Blackstone 2 Artistic A1 106H22 — ZIRKONZAHN SRLIPS e.max ZirCAD — IVOCLAR VIVADENT AKTIENGESELLSCHAFTLuminesse Zirconia Blocks — TALLADIUM, INC.Pürzir — Seattle Bioceramics, Inc.priti®multidisc ZrO2 — Pritidenta GmbHLuxisse — HEANY INDUSTRIES, INC.Bloomden — Bloomden Bioceramics (Hunan) Co., Ltd.Luna — OPA DENTAL LLCNacera® Pearl Natural — Dental Direkt GmbHpriti®multidisc ZrO2 — Pritidenta GmbHVITA TITANKERAMIK — Vita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co KommanditgesellschaftIPS Classic — IVOCLAR VIVADENT AKTIENGESELLSCHAFTAmber® Mill Q — Hass CorporationChang's Iris — U&C International Co.,LtdEstar-Z — Osstem Implant Co.,Ltd.LUXEN 5G — DENTALMAX CO.,LTDCreation Willi Geller — KLEMA Dentalprodukte GmbHBloomden — Bloomden Bioceramics (Hunan) Co., Ltd.Dental Zirconia Blank — Hunan Qinghaopuzhong Technology Co., Ltd.Prettau 2 Dispersive 0M1 106H18 — ZIRKONZAHN SRLIluzion — OPA DENTAL LLCIluzion — OPA DENTAL LLCCercon® ceram love — DeguDent GmbHGC Initial™ — Gc America Inc.
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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