# Prime Dental Manufacturing, Inc.

- Location (FDA's records): Chicago, IL
- FDA decisions: 9 (2000–2012): 9 510(k) clearances
- Product codes: EBF (5), DYH (1), EMA (1), EIE (1), EBC (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Recent decisions
- K112574: Prime-Dent Dual Cure Composite Luting Cement (Jan 23, 2012)
- K022675: Prime-Dent Automix Dual Cure Core Build UP Material (Nov 7, 2002)
- K021524: Light Cure Dental Dam (Jul 19, 2002)
- K013970: Prime-Dent Hema Desensitizer (Feb 19, 2002)
- K012794: Prime-Dent Chemical Cure Pit & Fissure Sealant (Nov 5, 2001)
- K012761: Prime-Dent Visible Light Cure Pit & Fissure Sealant (Nov 1, 2001)
- K012673: Prime-Dent One-Step Orthodontic Adhesive Bonding System (Oct 24, 2001)
- K001108: Prime-Dent Visible Light Cure Composite Restorative Material (May 30, 2000)

Source page: https://510kreport.com/company/prime-dental-manufacturing