# K052780: Dentaplast Hot, Model 16-XXX

- Pathway: 510(k) (Traditional)
- Applicant: Bredent-Products For the Dental Technician Laborat
- Decided: Dec 21, 2005 after 79 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: 1 generation back to K831647 (1983). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K831647: Denture Relining, Repair/Rebasing Resin, Dentsply Intl. (1983) Summary page 1.

## Indications for use
The bredent denture relining, repairing or rebasing resin is intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base.

Source page: https://510kreport.com/device/K052780
Methodology: https://510kreport.com/methodology