# K061264: Tempfx Esthetic Provisional System

- Pathway: 510(k) (Special)
- Applicant: Dentsply International, Inc.
- Decided: May 23, 2006 after 18 days
- Product code: EBG (Crown And Bridge, Temporary, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3770
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K904251 (1991). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K904251: New Triad VLC Crown & Bridge Provisional Material, Dentifax Intern, Inc. (1991) Summary page 1.

## Most influential descendants
- K080311: Modified Temprx Esthetic Provisional System (2008), 0 descendants of its own

## Indications for use
TEMPFX ESTHETIC PROVISIONAL SYSTEM is indicated for fabrication of provisional dental restorations.

Source page: https://510kreport.com/device/K061264
Methodology: https://510kreport.com/methodology