# K984451: D-Sign I (R&D Project DW263 #24)

- Pathway: 510(k) (Traditional)
- Applicant: Ivoclar North America, Inc.
- Decided: Jan 19, 1999 after 35 days
- Product code: EJS (Alloy, Other Noble Metal)
- Device class: 2
- Regulation: 21 CFR 872.3060
- 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
Indications for Use: D-Sign is to be used with conventional feldpathic porcelains. Also recommended for 3/4 crowns, telescop crowns, conus crowns, posts, attachments, short and long span bridges, PFM crowns.

Source page: https://510kreport.com/device/K984451
Methodology: https://510kreport.com/methodology