# K230487: Dental Lithium Disilicate Glass-Ceramic

- Pathway: 510(k) (Traditional)
- Applicant: Fuzhou Rick Brown Biomaterials Co., Ltd.
- Decided: Jul 3, 2023 after 130 days
- Product code: EIH (Powder, Porcelain)
- Device class: 2
- Regulation: 21 CFR 872.6660
- 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 K051705 (2005). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051705: Ips E.Max Cad/Ips E.Max Zircad, Ivoclar Vivadent, Inc. (2005) Summary page 5.

## Most influential descendants
- K252789: Glass Ceramic (2025), 0 descendants of its own
- K242740: Dental Lithium Disilicate Glass Ceramic ( HT, ML-HT, LT, ML-LT, MT, MO, HO) (2024), 0 descendants of its own

## Indications for use
Dental Lithium Disilicate Glass-Ceramic is available using CAD/CAM and hot pressing techniques for the preparation of full ceramic crowns, inlays, onlays, veneer and full ceramic 3-unit anterior bridges.

Source page: https://510kreport.com/device/K230487
Methodology: https://510kreport.com/methodology