# K230410: DD medical polymers (PMMA)

- Pathway: 510(k) (Special)
- Applicant: Dental Direkt GmbH
- Decided: Jun 23, 2023 after 128 days
- Product code: EBI (Resin, Denture, Relining, Repairing, Rebasing)
- Device class: 2
- Regulation: 21 CFR 872.3760
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K924830 (1994). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153490: DD medical polymers, Dental Direkt GmbH (2016) Summary page 5.

## Indications for use
DD base P HI are pre-colored dental milling blanks made of impact-resistant PMMA for the manufacture of denture bases for removable dentures. DD base P HI is suitable for long-term use in the oral cavity up to 10 years. DD Bio Splint P HI are transparent dental milling blanks out of PMMA for the manufacture of splints, therapeutic splints and bite regulators for long-term application in the oral cavity up to 12 months.

Source page: https://510kreport.com/device/K230410
Methodology: https://510kreport.com/methodology