# K051705: Ips E.Max Cad/Ips E.Max Zircad

- Pathway: 510(k) (Traditional)
- Applicant: Ivoclar Vivadent, Inc.
- Decided: Oct 14, 2005 after 112 days
- Product code: EIH (Powder, Porcelain)
- Device class: 2
- Regulation: 21 CFR 872.6660
- Recalls of this device: 10 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
228 later devices descend from it; 21 cite it directly.
0 of 229 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K072569: Metoxit Cam-Blanks (2007), 186 descendants of its own
- K120822: Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN, Straumann Cares Variobase Abutment WN, ST (2012), 165 descendants of its own
- K150203: Medentika CAD/CAM Abutments (2015), 129 descendants of its own
- K150367: Neodent Implant System (2015), 89 descendants of its own
- K170588: DESS Dental Smart Solutions (2017), 86 descendants of its own

## Recalls of this device
- Apr 5, 2024 · Class II · Z-1704-2024: Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration
- Apr 5, 2024 · Class II · Z-1703-2024: Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration
- Apr 5, 2024 · Class II · Z-1706-2024: Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration
- Apr 5, 2024 · Class II · Z-1707-2024: Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration
- Apr 5, 2024 · Class II · Z-1708-2024: Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration
- Apr 5, 2024 · Class II · Z-1705-2024: Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration
- Apr 13, 2020 · Class II · Z-1840-2020: Restorations crack during the sintering process.
- Apr 13, 2020 · Class II · Z-1838-2020: Restorations crack during the sintering process.
- Apr 13, 2020 · Class II · Z-1839-2020: Restorations crack during the sintering process.
- Apr 13, 2020 · Class II · Z-1837-2020: Restorations crack during the sintering process.

## Indications for use
IPS e.max CAD is a CAD/CAM machinable glass ceramic based on lithium disilicate for the preparation of full ceramic crowns, inlays, onlays, and full ceramic 3-unit anterior bridges. IPS e.max ZirCAD consists of machinable zirconia blocks for the preparation of full ceramic crowns, onlays and 3- and 4-unit bridges and inlay bridges (anterior and molar.)

Source page: https://510kreport.com/device/K051705
Methodology: https://510kreport.com/methodology