# K120013: Tempspan Clear Matrix

- Pathway: 510(k) (Traditional)
- Applicant: Pentron Clinical
- Decided: May 22, 2012 after 140 days
- Product code: ELW (Material, Impression)
- Device class: 2
- Regulation: 21 CFR 872.3660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K913537 (1991). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K913537: Memosil C.D., Heraeus Kulzer, Inc. (1991) Summary page 1.
- K073005: Elite Glass, Zhermack S.P.A. (2007) Summary page 1.
- K914178: Corrected-V.P.S., Jeneric/Pentron, Inc. (1992) Summary page 1.

## Most influential descendants
- K132599: Smilebond System (2014), 0 descendants of its own

## Indications for use
TempSpan Clear Matrix is indicated for: Use as a clear template for intra oral polymerization of light activated materials to create temporary restorations. Use as a general impression material for monophase impression techniques.

Source page: https://510kreport.com/device/K120013
Methodology: https://510kreport.com/methodology