# K212541: 3Delta Denture Base - 3Delta Denture Bond - 3Delta Denture Fix

- Pathway: 510(k) (Traditional)
- Applicant: Deltamed GmbH
- Decided: Jan 10, 2022 after 151 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
Production of dentures. * 3Delta Denture Base: Light curing resin for additive manufacturing of denture bases * 3Delta Denture Bond: Light curing bonding agent for denture teeth and denture bases * 3Delta Denture Fix: Dual curing cementation composite for denture teeth and denture bases

Source page: https://510kreport.com/device/K212541
Methodology: https://510kreport.com/methodology