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GC Initial™
Gc America Inc. · Model 877065 · UDI-DI 15400556700522
EIH
Prescription
1
510(k) clearances
51
Adverse events
35
Recalls
161
Facilities
Description
GC Initial™ MC Bleach Set, Opaque Modifier (OM-1); Dentin (20g) BLD-1, BLD-2,Bleach Enamel (20g) BL-E, Enamel Opalescence (20g) EOP-1, Fluo Dentine (20g) FD-91; Modeling Liquid (2x25mL), Opaque Liquid (1x25mL)
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 patient's mouth there i |
| 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 range. The acceptable |
| 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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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.