# K022150: Trionomer

- Pathway: 510(k) (Traditional)
- Applicant: Pentron Clinical Technologies
- Decided: Aug 21, 2002 after 50 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
Trionomer is a resin reinforced glass ionomer cementation system used for the following: Luting porcelain-fused-to-metal crowns and bridges to tooth structure, amalgam, composite or glass ionomer core buildings; Luting metal inlays, onlays or crowns; Luting pre-fabricated and cast posts; Luting orthodontic appliances; Luting crowns made with all-alumina or all zirconia cores or other ceramic restorations recommending using conventional cements; Cavity liners; Primary teeth cavity fillings; Non-stress bearing restorations such as class V fillings.

Source page: https://510kreport.com/device/K022150
Methodology: https://510kreport.com/methodology