# K153490: DD medical polymers

- Pathway: 510(k) (Traditional)
- Applicant: Dental Direkt GmbH
- Decided: May 13, 2016 after 161 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: 4 generations back to K924830 (1994). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150432: Idodentine Disc, Idodentine Block, Union Dental S.A. (2015) Summary page 4.

## Most influential descendants
- K230410: DD medical polymers (PMMA) (2023), 0 descendants of its own

## Indications for use
DD medical polymers are indicated for temporary (≤ 12 months) crowns, bridges and bite splints. Applications include both anterior and posterior structures.

Source page: https://510kreport.com/device/K153490
Methodology: https://510kreport.com/methodology