# K971138: Dinabase (TM)

- Pathway: 510(k) (Traditional)
- Applicant: Sultan Chemists, Inc.
- Decided: Jul 21, 1997 after 115 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
Intended to reline a denture surface that contacts tissue--for temporary or provisional usage. Not for OTC use.

Source page: https://510kreport.com/device/K971138
Methodology: https://510kreport.com/methodology