# K200039: P pro Crown & Bridge

- Pathway: 510(k) (Traditional)
- Applicant: Deltamed GmbH
- Decided: Jul 31, 2020 after 205 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: 3 generations back to K924830 (1994). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 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 5.
- 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 5.
- K101710: Luxatemp Ultra /Star, Dmg USA, Inc. (2010) Summary page 5.

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

## Indications for use
Additive production of temporary anterior and posterior restorations, e.g. - Single tooth crowns. - Bridges (max. six units, max. two consecutive pontics). - Veneers, Inlays, Onlays.

Source page: https://510kreport.com/device/K200039
Methodology: https://510kreport.com/methodology