# K091647: Injectafil

- Pathway: 510(k) (Traditional)
- Applicant: Apex Dental Materials, Inc.
- Decided: Sep 21, 2009 after 104 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
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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
InjectafilTM is a dual cured (photo initiated, free radical polymerization and / or peroxide tertiary amine initiated free radical polymerization) injectable composite material, designed for use as a filling material for all direct dental restorations, a resin cement for the delivery of indirect restorations or a core build up material. InjectafilTM is a composite material which, when utilized properly, provides a material for direct dental restorations. InjectafilTM can also be used as a resin cement for the delivery of indirect restorations or as a core build up material. InjectafilTM is compatible with all other methacrylate based dental materials.

Source page: https://510kreport.com/device/K091647
Methodology: https://510kreport.com/methodology