# K031010: Miracle 98

- Pathway: 510(k) (Traditional)
- Applicant: Sb Lucius, Inc.
- Decided: Jun 25, 2003 after 86 days
- Product code: EJT (Alloy, Gold-Based 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
Longest line of descent: 1 generation back to K002645 (2000). 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)
- K002645: Jel Bios Pure, J.F. Jelenko & Co., Inc. (2000)

## Indications for use
MIRACLE 98 is intended for manufacturing: - Porcelain to metal fabrication of single units

Source page: https://510kreport.com/device/K031010
Methodology: https://510kreport.com/methodology