# Ultradent Products Inc. / Oratech, LLC

- Location (FDA's records): South Jordan, UT
- FDA decisions: 2 (2013–2013): 2 510(k) clearances
- Product codes: EMA (1), LBH (1)
- Predicates its devices cite: 2 (0 its own); citations of its devices by later devices: 4 (0 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Shofu Dental Corp.: 1 (https://510kreport.com/company/shofu-dental)
- Ultradent Products, Inc.: 1 (https://510kreport.com/company/ultradent-products)

## Firms that cite its devices most
- Nanova Biomaterials, Inc.: 1 (https://510kreport.com/company/nanova-biomaterials)
- Theodent, LLC: 1 (https://510kreport.com/company/theodent)
- Pac-Dent International, Inc.: 1 (https://510kreport.com/company/pac-dent-international)
- Nagy Oral Technology Qinhuangdao Co., Ltd.: 1 (https://510kreport.com/company/nagy-oral-technology-qinhuangdao)

## Its most-cited devices
- K132109: Enamelast (2013), cited by 4

## Recent decisions
- K132109: Enamelast (Nov 1, 2013)
- K132255: Ultracem (Oct 24, 2013)

Source page: https://510kreport.com/company/ultradent-products-oratech