# K142043: Insync ZR High Translucency Zirconia

- Pathway: 510(k) (Abbreviated)
- Applicant: Jensen Industries, Inc.
- Decided: Dec 18, 2014 after 143 days
- Product code: EIH (Powder, Porcelain)
- Device class: 2
- Regulation: 21 CFR 872.6660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K830955 (1983). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130991: Nexxzr (TM)T and Nexxzr (TM)S, Sagemax Bioceramics, Inc. (2014) Summary page 4.

## Indications for use
InSync ZR High Translucency Zirconia blanks are intended for use in construction of dental crowns, copings, inlays, and fixed partial dentures up to 3 units. While primarily intended for full contour crowns and bridges, it is also suitable for copings and substructures.

Source page: https://510kreport.com/device/K142043
Methodology: https://510kreport.com/methodology