# K111696: Opal Band Cement

- Pathway: 510(k) (Traditional)
- Applicant: Ultradent Products, Inc.
- Decided: Sep 7, 2011 after 82 days
- Product code: DYH (Adhesive, Bracket And Tooth Conditioner, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3750
- 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 K950514 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K950514: Tri-Cure Glass Ionomer Orthodontic Band Cement, 3M Unitek (1995) Summary page 1.

## Indications for use
Opal® BandTM Cement uses chemical, light polymerization and glass jonomer to cement all types of orthodontic bands to the teeth.

Source page: https://510kreport.com/device/K111696
Methodology: https://510kreport.com/methodology