# K021613: Niveous Liquid Dam

- Pathway: 510(k) (Traditional)
- Applicant: Shofu Dental Corp.
- Decided: Jun 20, 2002 after 35 days
- Product code: EIE (Dam, Rubber)
- Device class: 1
- Regulation: 21 CFR 872.6300
- 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 K971284 (1997). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972775: Fastdam, Interdent, Inc. (1998) Summary page 2.
- K971284: Opaldam, Ultradent Products, Inc. (1997) Summary page 1.

## Indications for use
The Niveous Liquid Dam resin is indicated to protect soft tissue during in-office bleaching.

Source page: https://510kreport.com/device/K021613
Methodology: https://510kreport.com/methodology