# Ultradent Products, Inc.

- Location (FDA's records): South Jordan, UT
- FDA decisions: 104 (1992–2026): 104 510(k) clearances
- Product codes: KLE (19), EBF (17), EMA (9), LBH (9), EBC (7), EBZ (7), KJJ (5), KIF (5), EJK (5), MVL (4), DYH (4), DYW (3)
- 510(k) review time since 2016: median 3 days, against 105 for FDA's reviews in the same codes and years (9 of 10 faster)
- Predicates its devices cite: 48 (24 its own); citations of its devices by later devices: 71 (24 its own)
- Recalls linked to its devices: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- DiaDent Group International: 2 (https://510kreport.com/company/diadent-group-international)
- Bisco, Inc.: 2 (https://510kreport.com/company/bisco)
- Voco GmbH: 2 (https://510kreport.com/company/voco)
- 3M Unitek: 2 (https://510kreport.com/company/3m-unitek)
- 3M Company: 2 (https://510kreport.com/company/3m)
- Dentsply International, Inc.: 1 (https://510kreport.com/company/dentsply-international)
- Maruchi: 1 (https://510kreport.com/company/maruchi)
- Ivoclar North America, Inc.: 1 (https://510kreport.com/company/ivoclar-north-america)

## Firms that cite its devices most
- Inter-Med/Vista Dental Products: 4 (https://510kreport.com/company/inter-med-vista-dental-products)
- Ultradent Product, Inc.: 3 (https://510kreport.com/company/ultradent-product)
- Centrix, Inc.: 2 (https://510kreport.com/company/centrix)
- Denali Corporation: 2 (https://510kreport.com/company/denali)
- CAO Group, Inc.: 2 (https://510kreport.com/company/cao-group)
- Inter-Med, Inc.: 2 (https://510kreport.com/company/inter-med)
- Kuraray Medical, Inc.: 2 (https://510kreport.com/company/kuraray-medical)
- Den-Mat Holdings, LLC: 2 (https://510kreport.com/company/den-mat-holdings)

## Its most-cited devices
- K110582: Valo Cordless (2011), cited by 6
- K061438: Ultraez Desensitizing Gel (2007), cited by 4
- K925375: Consepsis Scrub (1993), cited by 4
- K123215: Viscostat Clear (2013), cited by 3
- K993846: Ultraseal XT Plus (2000), cited by 3
- K100752: Peak Universal Bond (Light Cure Resin Adhesive and Chlorhexidine) (2010), cited by 3

## Recent decisions
- K262228: Transcend Bulk Fill Flowable Composite (Jul 1, 2026)
- K261404: UltraEZ (Apr 30, 2026)
- K240743: Peak Universal Bond (Mar 20, 2024)
- K240694: FORMA Composite (Shade A3D) (Mar 15, 2024)
- K221909: J-Temp (Jul 1, 2022)
- K220471: VALO X, VALO X Accessory Lenses (Feb 22, 2022)
- K211905: UltraCal XS (Oct 13, 2021)
- K211237: UltraTemp Rez II (Jul 13, 2021)

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