# K171729: Fixtemp C&B

- Pathway: 510(k) (Traditional)
- Applicant: Dreve Dentamid GmbH
- Decided: Dec 13, 2017 after 184 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: 2 generations back to K020092 (2002). 2 ancestors in all.
1 later device descends 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)
- K102917: Fixtemp C&B, Exacta Dental Direct, Inc. (2011) Summary page 4.

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

## Indications for use
Fixtemp® C&B is a resin based material used to fabricate temporary crowns and bridges.

Source page: https://510kreport.com/device/K171729
Methodology: https://510kreport.com/methodology