# K133182: HTFX-222

- Pathway: 510(k) (Traditional)
- Applicant: GC America, Inc.
- Decided: Apr 9, 2014 after 174 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: 3 generations back to K042819 (2004). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123631: MFP-051, GC America, Inc. (2013) Summary page 1.
- 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) Summary page 1.

## Indications for use
1. Liner or base 2. Blocking out undercuts 3. Repair of direct and indirect aesthetic restorations: composites, veneers, crowns and bridges (including temporary crowns and bridges), defect margins when margins are in enamel 4. Sealing hypersensitive areas 5. Fissure sealant 6. Direct restorative for small Class 1,11, 111, IV, and V cavities

Source page: https://510kreport.com/device/K133182
Methodology: https://510kreport.com/methodology