Home › Device types › EIH
Powder, Porcelain
FDA product code EIH · Class 2 · Dental
95,745
Registered devices
51
Adverse events
35
Recalls
486
510(k) clearances
Devices with this code
Creation Willi Geller — KLEMA Dentalprodukte GmbHGC Initial™ — Gc America Inc.GC Initial™ — Gc America Inc.VITA VM 9 — Vita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co KommanditgesellschaftGC Initial™ — Gc America Inc.LUXEN Smile — DENTALMAX CO.,LTDLUXEN Smile, LUXEN Zr — DENTALMAX CO.,LTDLUXEN CL — DENTALMAX CO.,LTDLUXEN CL — DENTALMAX CO.,LTDArena — ARUM DENTISTRY Co., Ltd.BruxZir — Prismatik Dentalcraft, IncVintage ZR — SHOFU DENTAL CORPORATIONCeramco® II — Dentsply International Inc.HC-Zirkonia Opaltranspa OT1, 100g — Kulzer GmbHVITA TITANKERAMIK — Vita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaftupcera Dental Zirconia Pre-Shaded Blank — Liaoning Upcera Co.,Ltd.Aidite — Aidite (Qinhuangdao) Technology Co., Ltd.Ceramco® iC — Dentsply International Inc.Vericore ZR Pro ML — WHIP-MIX CORPORATIONICE Ceramics Dynamic Dentine D3 D (1 kg) — ZIRKONZAHN SRLZirlux FC2 — ARDENT, INC.Iluzion — OPA DENTAL LLCBruxZir NOW — Prismatik Dentalcraft, IncCeramic Tissue 3 (20 g) — ZIRKONZAHN SRL
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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