# K992248: Post Cement HI-X

- Pathway: 510(k) (Traditional)
- Applicant: Bisco, Inc.
- Decided: Aug 25, 1999 after 50 days
- Product code: EBF (Material, Tooth Shade, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3690
- 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 K940030 (1994). 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)
- K940030: Bisco Composite, Bisco, Inc. (1994) Summary page 1.

## Indications for use
1. Cementation of posts 2. Cementation of metal posts fabricated with precious, semi-precious or non-precious metals

Source page: https://510kreport.com/device/K992248
Methodology: https://510kreport.com/methodology