# K972775: Fastdam

- Pathway: 510(k) (Traditional)
- Applicant: Interdent, Inc.
- Decided: Feb 27, 1998 after 218 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K021613: Niveous Liquid Dam (2002), 0 descendants of its own

## Indications for use
@ 601:‘(’ Rsue ifiow’r (ON @ Moisture TReveNTION SR Aeriel

Source page: https://510kreport.com/device/K972775
Methodology: https://510kreport.com/methodology