# K261485: Tetric plus Fill;Tetric plus Flow

- Pathway: 510(k) (Traditional)
- Applicant: Ivoclar Vivadent, Inc.
- Decided: Jul 1, 2026 after 57 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: 2 generations back to K111958 (2011). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183380: Tetric PowerFill, Ivoclar Vivadent, AG (2019) Summary page 5.

## Indications for use
Tetric plus Fill: — Missing tooth structure in anterior and posterior teeth Types of restorations: — Restorations of all types of permanent dentition (including the replacement of individual cusps in the posterior region) — Reconstructive build-ups — Restorations of deciduous teeth — Repair of composite / ceramic restorations — Direct veneers — Sealing of implant screw channels Tetric plus Flow: — Missing tooth structure in anterior and posterior teeth Types of restorations: — Initial layer up to 4 mm in Class I and II restorations* — Small direct restorations in permanent teeth (not occlusion-bearing)* — Restorations of deciduous teeth — Liner under direct restorations of all cavity classes — Class V restorations — Extended fissure sealings — Repair of composite / ceramic restorations — Sealing of implant screw channels *In case of occlusion-bearing restorations, apply a final layer using a sculptable composite material.

Source page: https://510kreport.com/device/K261485
Methodology: https://510kreport.com/methodology