# K120784: Tuff-Temp 2.0

- Pathway: 510(k) (Traditional)
- Applicant: Pulpdent Corporation
- Decided: Jun 8, 2012 after 85 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 K081810 (2008). 1 ancestor in all.
6 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081810: Pulpdent Temporary Crown and Bridge Material, Pulpdent Corporation (2008) Summary page 1.

## Cited in the summary but kept off the family tree
- K013674: Luxatemp/Luxatemp Solar/Instatemp, Dmg USA, Inc. (2002). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K123265: Rmgi Low Viscosity (2012), 5 descendants of its own
- K130223: Rmgi Fill (2013), 4 descendants of its own
- K153249: Pulpdent Solo Flowable Composite with MCP (2016), 1 descendant of its own
- K250953: Equia LC One (2025), 0 descendants of its own
- K210045: Activa Presto Pack (2021), 0 descendants of its own

## Indications for use
Pulpdent Tuff-Temp 2.0 is a dual-cure, glass-filled, resin composite used by the dental professional to make a temporary prosthesis, such as a crown or bridge, to be used until a permanent restoration can be fabricated.

Source page: https://510kreport.com/device/K120784
Methodology: https://510kreport.com/methodology