# Itena Clinical

- Location (FDA's records): Laval, CA
- FDA decisions: 8 (2013–2017): 8 510(k) clearances
- Product codes: EMA (4), KIF (1), KLE (1), EBC (1), EBF (1)
- Predicates its devices cite: 13 (1 its own); citations of its devices by later devices: 2 (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
- Dentsply Intl.: 2 (https://510kreport.com/company/dentsply-intl)
- Ivoclar Vivadent, Inc.: 2 (https://510kreport.com/company/ivoclar-vivadent)
- Dmg USA, Inc.: 2 (https://510kreport.com/company/dmg-usa)
- Premier Dental Products Co.: 1 (https://510kreport.com/company/premier-dental-products)
- Sybron Dental Specialties, Inc.: 1 (https://510kreport.com/company/sybron-dental-specialties)
- Kuraray Medical, Inc.: 1 (https://510kreport.com/company/kuraray-medical)
- Jeneric/Pentron, Inc.: 1 (https://510kreport.com/company/jeneric-pentron)
- Ivoclar North America, Inc.: 1 (https://510kreport.com/company/ivoclar-north-america)

## Firms that cite its devices most
- Pac-Dent International, Inc.: 1 (https://510kreport.com/company/pac-dent-international)

## Its most-cited devices
- K122521: Prevent Seal (2013), cited by 1
- K121804: Provitemp, Dentotemp, Totalcem, Dentocem (2013), cited by 1

## Recent decisions
- K170207: Obturys (Jul 31, 2017)
- K162960: TotalC-Ram (Mar 14, 2017)
- K122551: Provitemp (Jun 14, 2013)
- K122521: Prevent Seal (Jun 11, 2013)
- K122549: Dento Temp (Apr 26, 2013)
- K121804: Provitemp, Dentotemp, Totalcem, Dentocem (Apr 19, 2013)
- K122522: Dentoetch Quickbond Bond Activator (Mar 19, 2013)
- K121769: Dentocore / Dentocore Body (Mar 5, 2013)

Source page: https://510kreport.com/company/itena-clinical