# K020269: Procera Allceram Bridge Material

- Pathway: 510(k) (Traditional)
- Applicant: Procera Sandvik AB
- Decided: Mar 27, 2002 after 58 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: 2 generations back to K920887 (1992). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983453: Procera Allceram Fusing Material, Nobel Biocare Uas, Inc. (1998) Summary page 1.

## Indications for use
Procera® AllCeram Bridge Material is composed of Procera® AllCeram Connection Material (a premixed suspension of aluminium oxide particles, dispersant of the particles, binder of the particles and deionised water) and Procera® AllCeram Fusing Material (a suspension of glass material and water) Procera® AllCeram Bridge Material is used to fuse together the sections of the core material in densely sintered aluminium oxide of a dental bridge.

Source page: https://510kreport.com/device/K020269
Methodology: https://510kreport.com/methodology