# K102917: Fixtemp C&B

- Pathway: 510(k) (Traditional)
- Applicant: Exacta Dental Direct, Inc.
- Decided: Jun 17, 2011 after 259 days
- Product code: EBG (Crown And Bridge, Temporary, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3770
- 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 K020092 (2002). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 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.

## Most influential descendants
- K171729: Fixtemp C&B (2017), 1 descendant of its own
- K241226: Fixtemp® C&B 4:1 (2024), 0 descendants of its own

## Indications for use
FixTemp C&B ta is a chemically catalyzed, highly filled, resin based restorative material used to fabricate temporary crowns and bridges. FixTemp C&B is a chemically catalyzed, highly filled, resin based restorative material used to fabricate temporary crowns and bridges.

Source page: https://510kreport.com/device/K102917
Methodology: https://510kreport.com/methodology