# K102776: Extra-Oral, Additive Computer Aided Manufacture and Curing System

- Pathway: 510(k) (Traditional)
- Applicant: Deltamed GmbH
- Decided: Feb 18, 2011 after 147 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 K070991 (2007). 1 ancestor in all.
12 later devices descend from it; 5 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070991: Vita Cad-Temp for Inlab, Model, VX59-4002, VX59-4010, VX59-4102, VX59-4110, VX59-4202, VX59-4210, VX59-4302, VX59-4310, Vita (2007) Summary page 1.

## Most influential descendants
- K180657: Resin for Temporary Crown & Bridge (2018), 4 descendants of its own
- K211101: E-Temp (2021), 2 descendants of its own
- K201827: GR-17 Resin System (2020), 1 descendant of its own
- K200273: FREEPRINT temp (2020), 1 descendant of its own
- K200039: P pro Crown & Bridge (2020), 1 descendant of its own

## Indications for use
e-DENT TEMPORARY resin is indicated for the fabrication of temporary dental restorations in conjunction with extra-oral curing light equipment.

Source page: https://510kreport.com/device/K102776
Methodology: https://510kreport.com/methodology