# K152215: Dentalos Plus Mono, Dentalos Plus Multicolor

- Pathway: 510(k) (Traditional)
- Applicant: Dentalplus GmbH
- Decided: Jan 19, 2016 after 165 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 K070991 (2007). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122025: Brightglass Brightglass M, Ktk Medical Supplies GmbH (2012) Summary page 4.

## Indications for use
DENTALOS PLUS discs are milling blanks consisting of Polymethylmethacrylate (PMMA) and designed for the fabrication of long-term temporary crown and bridgework. They are machined by use of the CAD/CAM technique. DENTALOS PLUS discs are recommended for manufacturing substructures of single tooth crowns and bridgeworks with up to two pontics.

Source page: https://510kreport.com/device/K152215
Methodology: https://510kreport.com/methodology