# K971927: HI Dense TC

- Pathway: 510(k) (Traditional)
- Applicant: Shofu Dental Corp.
- Decided: Jun 30, 1997 after 34 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
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
HI DENSE TC is a glass ionomer sliver reinforced restorative dental product. It is indicated for use in: Class I and II cavities in deciduous teeth. Repair of amalgam restored teeth when either tooth or restoration has fractured. Class I and II cavities in selected permanent teeth. Lining under amalgam and posterior composite restorations. In other classes of cavity where radiopacity rather than aesthetics is a prime requirement. As a core build-up material under crowns. On the root surfaces for locating overdentures. Long term temporary replacements for cusp(s). Repair to crown margins.

Source page: https://510kreport.com/device/K971927
Methodology: https://510kreport.com/methodology