# K021457: Flex Span Temporary Crown & Bridge Material

- Pathway: 510(k) (Traditional)
- Applicant: Pentron Corp.
- Decided: Aug 1, 2002 after 87 days
- Product code: EBG (Crown And Bridge, Temporary, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3770
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K020092 (2002). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020092: Temphase, Kerr Dental Materials Center (2002) Summary page 1.

## Recalls of this device
- Oct 22, 2009 · Not classified · Z-0482-2010: Pentron Clinical Technologies LLC received two (2) complaints alleging that the TempSpan Dual-Cure Temporary Crown and Bridge Material was not setting. Investigation of product in inventory was conduc

## Indications for use
Flex Span Temporary Crown & Bridge Material is intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.

Source page: https://510kreport.com/device/K021457
Methodology: https://510kreport.com/methodology