# K974413: Permaflo

- Pathway: 510(k) (Traditional)
- Applicant: Ultradent Products, Inc.
- Decided: Feb 2, 1998 after 70 days
- Product code: EBF (Material, Tooth Shade, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3690
- Recalls of this device: 1 (0 Class I)
- 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
- K111836: Permashade Veneer Cement (2011), 0 descendants of its own

## Recalls of this device
- Aug 31, 2020 · Class II · Z-0053-2021: Due to a potential manufacturing issue (cross contamination), composite is non-homogeneous.

## Indications for use
PermaFlo can be used for: 1. Anterior and posterior restorations, such as Class I, II, III, IV, and V. 2. Luting translucent inlays and onlays. Permalute (chemical cure) is recommended for more opaque or thick inlays/onlays where light cure is not predictable 3. Direct veneers and other restorative procedures 4. Restoring missing subgingival tooth structure prior to endodontic procedures (this is referred to as the “donut” technique).

Source page: https://510kreport.com/device/K974413
Methodology: https://510kreport.com/methodology