# K251946: G aenial Universal Injectable II

- Pathway: 510(k) (Traditional)
- Applicant: GC America, Inc.
- Decided: Aug 29, 2025 after 65 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: 12 generations back to K931812 (1993). 69 ancestors in all.
No later device cites it as a predicate yet.
0 of 70 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173500: NMF004A, GC America, Inc. (2018) Summary page 5.
- K153231: G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi Primer, GC America, Inc. (2016) Summary page 5.
- K231817: AlignerFlow LC, Voco GmbH (2023) Summary page 5.

## Indications for use
1. Direct restorative for Class 1, 11, 111, IV, and V cavities 2. Fissure sealant 3. Sealing hypersensitive areas 4. Repair of (in)direct aesthetic restorations, temporary crown & bridge, defect margins when margins are in enamel 5. Blocking out undercuts 6. Liner or base 7. Core build-up 8. Adhesive cementation of ceramic and composite veneers, inlays and onlays with a thickness (<2.0 mm) and translucency that enables the complete light curing of the cement 9. Retention of aligner e.g. by fabrication of aligner attachments

Source page: https://510kreport.com/device/K251946
Methodology: https://510kreport.com/methodology