# K080311: Modified Temprx Esthetic Provisional System

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Interntional
- Decided: Apr 18, 2008 after 72 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: 2 generations back to K904251 (1991). 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)
- K061264: Tempfx Esthetic Provisional System, Dentsply International, Inc. (2006) Summary page 1.

## Indications for use
The Modified TempRx Esthetic Provisional System is: · Indicated for the fabrication of all provisional dental restorations for a term of use of up to 6 months. * Indicated for fabrication of the following long-term provisional dental restorations (without metal substructures) for a term of use greater than 6 months up to 3 years: · Inlays/ Onlays * Veneers * Crowns * 3-unit bridges through the 2nd bicuspid. * Indicated for the build up of a tooth on denture base resins.

Source page: https://510kreport.com/device/K080311
Methodology: https://510kreport.com/methodology