# K111855: HY-Bond Resiglass

- Pathway: 510(k) (Traditional)
- Applicant: Shofu Dental Corp.
- Decided: Nov 17, 2011 after 141 days
- Product code: EMA (Cement, Dental)
- Device class: 2
- Regulation: 21 CFR 872.3275
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K132255: Ultracem (2013), 0 descendants of its own

## Indications for use
Hy-Bond Resiglass is intended for cementation of restorations (including inlay, crown and bridge) made of metal, ceramics (porcelain) and resin to natural teeth. This product is also intended for cementation of orthodontic appliances (metal bracket, ceramics bracket, etc.) to natural teeth,

Source page: https://510kreport.com/device/K111855
Methodology: https://510kreport.com/methodology