# K141562: MSN-006

- Pathway: 510(k) (Traditional)
- Applicant: GC America, Inc.
- Decided: Sep 5, 2014 after 85 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). 30 ancestors in all.
No later device cites it as a predicate yet.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073296: TEMPXN28, 3M Espe AG Dental Products (2008) Summary page 4.
- K101710: Luxatemp Ultra /Star, Dmg USA, Inc. (2010) Summary page 4.
- K082434: GDLS-200, GC America, Inc. (2008) Summary page 4.
- K073283: GC GAM-100, GC America, Inc. (2008) Summary page 4.
- K123631: MFP-051, GC America, Inc. (2013) Summary page 4.

## Indications for use
1. Fabrication of temporary crowns, bridges, inlays, onlays and veneers 2. Fabrication of long-term temporary restorations

Source page: https://510kreport.com/device/K141562
Methodology: https://510kreport.com/methodology