# K130991: Nexxzr (TM)T and Nexxzr (TM)S

- Pathway: 510(k) (Traditional)
- Applicant: Sagemax Bioceramics, Inc.
- Decided: Feb 10, 2014 after 306 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: 6 generations back to K830955 (1983). 14 ancestors in all.
7 later devices descend from it; 4 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062695: Sagemax Z-Blank, Sagemax Bioceramics, Inc. (2006) Summary page 1.

## Most influential descendants
- K193084: TIB Abutment System (2020), 3 descendants of its own
- K230873: Angulated Screw Channel (ASC) Solution Abutments & SI-BASE Abutments (2023), 0 descendants of its own
- K222469: TIB Abutments (2023), 0 descendants of its own
- K222457: Provata Implant System (2023), 0 descendants of its own
- K210884: 1Derful HS, 1Derful HT (2021), 0 descendants of its own

## Indications for use
NexxZr T and NexxZr S are intended for the fabrication and preparation of copings and full anatomical/full contour crowns, bridges, inlays and onlays for anterior and posterior segment restorations.

Source page: https://510kreport.com/device/K130991
Methodology: https://510kreport.com/methodology