# K162654: mollosil plus

- Pathway: 510(k) (Traditional)
- Applicant: Detax GmbH & Co. KG
- Decided: Mar 13, 2017 after 171 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Used for fabricating long-term soft denture relinings by direct or indirect application.

Source page: https://510kreport.com/device/K162654
Methodology: https://510kreport.com/methodology