# K123631: MFP-051

- Pathway: 510(k) (Traditional)
- Applicant: GC America, Inc.
- Decided: Jul 23, 2013 after 242 days
- Product code: EBF (Material, Tooth Shade, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3690
- 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 K042819 (2004). 5 ancestors in all.
39 later devices descend from it; 5 cite it directly.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082434: GDLS-200, GC America, Inc. (2008) Summary page 1.
- K091388: GCUC-505, GC America, Inc. (2009) Summary page 1.
- K032921: Premise, Sybron Dental Specialties, Inc. (2003) Summary page 1.
- K042819: Tetric Evoceram, Ivoclar Vivadent, Inc. (2004)

## Most influential descendants
- K133824: Cerasmart (2014), 32 descendants of its own
- K160425: CAD/CAMouflage Milling Bock (2016), 26 descendants of its own
- K162537: CAD/CAMouflage Milling Block (2016), 25 descendants of its own
- K201668: VarseoSmile Crown plus (2020), 24 descendants of its own
- K202846: Tera Harz (2021), 13 descendants of its own

## Indications for use
1. Direct restorative for class I, HI, all IV,V cavities. 2. Direct restorative for wedge-shaped defects and root surface cavities. 3. Direct restorative for veneers and diastema closure.

Source page: https://510kreport.com/device/K123631
Methodology: https://510kreport.com/methodology