# K971284: Opaldam

- Pathway: 510(k) (Traditional)
- Applicant: Ultradent Products, Inc.
- Decided: Jun 3, 1997 after 57 days
- Product code: EIG (Retractor, All Types)
- Device class: 1
- Regulation: 21 CFR 872.4565
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 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
- K151945: Triumph Resin Dam (2016), 1 descendant of its own
- K182118: armor LC (2019), 0 descendants of its own
- K021613: Niveous Liquid Dam (2002), 0 descendants of its own

## Indications for use
OpalDam resin is used to protect soft tissue adjacent to the teeth during in-office bleaching. OpalDam is used with Opalescence Xtra (35% hydrogen peroxide) “power” bleaching agent.

Source page: https://510kreport.com/device/K971284
Methodology: https://510kreport.com/methodology