# Opal Orthodontics by Ultradent Products

- Location (FDA's records): South Jordan, UT
- FDA decisions: 2 (2012–2015): 2 510(k) clearances
- Names in FDA's records: Opal Orthodontics by Ultradent Products (1); Opal Orthodontics by Ultradent Products, Inc. (1)
- Product codes: NJM (2)
- Predicates its devices cite: 2 (1 its own); citations of its devices by later devices: 1 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Cdb Corporation: 1 (https://510kreport.com/company/cdb)

## Its most-cited devices
- K113334: Avex CX2  and Avex CXI2 Ceramic Brackets (2012), cited by 1

## Recent decisions
- K152779: Avex CX2 (Nov 25, 2015)
- K113334: Avex CX2  and Avex CXI2 Ceramic Brackets (Feb 3, 2012)

Source page: https://510kreport.com/company/opal-orthodontics-by-ultradent-products