# Pac-Dent, Inc.

- Location (FDA's records): Brea, CA
- FDA decisions: 8 (2020–2022): 8 510(k) clearances
- Product codes: EBF (2), FXX (1), EBI (1), OXZ (1), KJJ (1), KLE (1), EFB (1)
- 510(k) review time since 2016: median 184 days, against 163 for FDA's reviews in the same codes and years (2 of 7 faster)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 1 (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 that cite its devices most
- Belport Company, Inc., Gingi-Pak: 1 (https://510kreport.com/company/belport-company-gingi-pak)

## Its most-cited devices
- K210412: Pac-Dent Ceramic Nanohybrid Resin (2021), cited by 1

## Recent decisions
- K202674: Medidenta High Speed Handpieces (Dec 12, 2022)
- K202920: OptiComp (May 25, 2022)
- K202831: The iMask Child's Face Mask (Aug 26, 2021)
- K210189: Pac-Dent Denture Base Resin (Jul 28, 2021)
- K210412: Pac-Dent Ceramic Nanohybrid Resin (Jul 26, 2021)
- K210186: PacBond One (Jul 16, 2021)
- K201182: iMask Disposable Surgical Face Mask (Feb 19, 2021)
- K200330: RC-Prime Root Canal Preparation Cream (Jul 6, 2020)

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