# K983453: Procera Allceram Fusing Material

- Pathway: 510(k) (Traditional)
- Applicant: Nobel Biocare Uas, Inc.
- Decided: Nov 18, 1998 after 49 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 K920887 (1992). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K913644: Vita in-Ceram, Vident (1992) Summary page 1.
- K920887: GDC-3338, Dental Solder Alloy, Deringer-Ney, Inc. (1992) Summary page 1.

## Most influential descendants
- K253191: DCMhotbond zircon (2026), 0 descendants of its own
- K020269: Procera Allceram Bridge Material (2002), 0 descendants of its own

## Indications for use
Nobel Biocare’s Procera® AllCeram Fusing Material is a glass based powder which is mixed with distilled water. It is intended to be used to fuse together the sections of an aluminum oxide dental bridge.

Source page: https://510kreport.com/device/K983453
Methodology: https://510kreport.com/methodology