# K211101: E-Temp

- Pathway: 510(k) (Traditional)
- Applicant: Envisiontec GmbH
- Decided: Jun 14, 2021 after 62 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 K070991 (2007). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102776: Extra-Oral, Additive Computer Aided Manufacture and Curing System, Deltamed GmbH (2011) Summary page 4.

## Most influential descendants
- K243370: DentaTOOTH (2025), 0 descendants of its own
- K242559: Digital Temp (2024), 0 descendants of its own

## Indications for use
E-Temp is a light-curable resin indicated for the fabrication of individual and fixed temporary full single crowns, temporary partial crowns and temporary bridges in dental laboratories. The material is an alternative to traditional restorative dental material. E-Temp is intended exclusively for professional dental work. Fabrication of dental applications with E-Temp requires a computer aided and manufacturing (CAD/CAM) system that includes the following components: digital dental files based on a digital impression or in case of artificial teeth for dental prostheses the digital dental files based on manufacturer’s data, a digital light processing (DLP) printer, and curing light equipment.

Source page: https://510kreport.com/device/K211101
Methodology: https://510kreport.com/methodology