# K972935: Super-Dent Intermediate Restorative Material

- Pathway: 510(k) (Traditional)
- Applicant: S.S. White Mfg., Ltd.
- Decided: Jan 29, 1998 after 174 days
- Product code: EMA (Cement, Dental)
- Device class: 2
- Regulation: 21 CFR 872.3275
- 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 K895487 (1990). 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)
- K895487: Temporary Dental Cement, Dentsply Intl. (1990) Summary page 2.

## Indications for use
This material is intended for use in dentistry as a base or cavity liner under permanent restorations and for temporary restorations to teeth as an interim measure to protect cavities before a permanent restoration can be completed.

Source page: https://510kreport.com/device/K972935
Methodology: https://510kreport.com/methodology