# K122039: Kingscross PL-C+B-10, Kingscross PL-C+B-12, Kingscross PL-C+B-08, Kingscross B

- Pathway: 510(k) (Traditional)
- Applicant: Kettenbach GmbH & Co. KG
- Decided: Dec 27, 2012 after 169 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: 5 generations back to K902115 (1990). 24 ancestors in all.
No later device cites it as a predicate yet.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K853052: Integrity, Dentsply Intl. (1985) Summary page 2.
- K101710: Luxatemp Ultra /Star, Dmg USA, Inc. (2010) Summary page 2.
- K924830: Luxatemp Automix, Dmg Chemisch Pharmazeutische Fabrik GmbH (1994) Summary page 2.
- K073296: TEMPXN28, 3M Espe AG Dental Products (2008) Summary page 2.

## Indications for use
Kingscross temporary crown and bridge material is intended to be used for fabrication of temporary prostheses, such as crowns, partial crowns, bridges, inlays, onlays and veneers, and for customization of prefabricated acrylic and metal crowns and for fabrication of long-term temporary restorations until a permanent restoration is fabricated.

Source page: https://510kreport.com/device/K122039
Methodology: https://510kreport.com/methodology