# K013859: Rhodia Bite Registration Material

- Pathway: 510(k) (Traditional)
- Applicant: Rhodia, Inc.
- Decided: Jan 29, 2002 after 69 days
- Product code: ELW (Material, Impression)
- Device class: 2
- Regulation: 21 CFR 872.3660
- 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. The FDA summary names no predicate by number.

## Indications for use
Rhodia Bite Registration Material is intended for taking impressions of the biting surfaces of the teeth used to set gypsum casts in the correct occlusal relationship when the casts are mounted on an articulator.

Source page: https://510kreport.com/device/K013859
Methodology: https://510kreport.com/methodology