# Pac-Dent International, Inc.

- Location (FDA's records): Brea, CA
- FDA decisions: 9 (2013–2017): 9 510(k) clearances
- Product codes: KJJ (3), EBC (1), PEM (1), EBF (1), MVL (1), ELW (1), LBH (1)
- Predicates its devices cite: 11 (0 its own); citations of its devices by later devices: 7 (0 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
- Inter-Med, Inc.: 2 (https://510kreport.com/company/inter-med)
- 3M Company: 2 (https://510kreport.com/company/3m)
- Itena Clinical: 1 (https://510kreport.com/company/itena-clinical)
- Tidi Products,Llc: 1 (https://510kreport.com/company/tidi-products)
- Scientific Pharmaceuticals, Inc.: 1 (https://510kreport.com/company/scientific-pharmaceuticals)
- Produits Dentaires Pierre Rolland: 1 (https://510kreport.com/company/produits-dentaires-pierre-rolland)
- Essential Dental Systems, Inc.: 1 (https://510kreport.com/company/essential-dental-systems)
- Kerr Corporation: 1 (https://510kreport.com/company/kerr)

## Firms that cite its devices most
- Unipack Medical Corporation: 1 (https://510kreport.com/company/unipack-medical)
- Premium Plus International Limited: 1 (https://510kreport.com/company/premium-plus-international)
- Mediclus Co., Ltd.: 1 (https://510kreport.com/company/mediclus)
- Inter-Med/Vista Dental Products: 1 (https://510kreport.com/company/inter-med-vista-dental-products)
- Bh Medical Products Co., Ltd.: 1 (https://510kreport.com/company/bh-medical-products)
- Innovative Product Brands, Inc.: 1 (https://510kreport.com/company/innovative-product-brands)
- Plasdent Corporation: 1 (https://510kreport.com/company/plasdent)

## Its most-cited devices
- K151123: Pac-Dent Barrier Sleeve, Cover-It (TM) Barrier Film (2016), cited by 4
- K162662: GingiDent Gingival Retraction Paste (2017), cited by 1
- K153528: PacEndo EDTA (2016), cited by 1
- K151150: Elements (2015), cited by 1

## Recent decisions
- K162662: GingiDent Gingival Retraction Paste (Oct 20, 2017)
- K160577: PacEndo Chlorhexidine (Jul 25, 2016)
- K151123: Pac-Dent Barrier Sleeve, Cover-It (TM) Barrier Film (Mar 3, 2016)
- K153528: PacEndo EDTA (Feb 1, 2016)
- K151852: PacEndo Sodium Hyprochlorite (Nov 10, 2015)
- K151150: Elements (Jul 28, 2015)
- K141717: Pacseal Pit & Fissure Sealant (Mar 9, 2015)
- K141422: Profluoro Fluoride Varnish (Sep 30, 2014)

Source page: https://510kreport.com/company/pac-dent-international