# Den-Mat Holdings, LLC

- Location (FDA's records): Lompoc, CA
- FDA decisions: 9 (2008–2026): 9 510(k) clearances
- Product codes: EBF (3), KLE (2), GEX (2), NXV (1), EBZ (1)
- 510(k) review time since 2016: median 89 days, against 108 for FDA's reviews in the same codes and years (1 of 3 faster)
- Predicates its devices cite: 15 (0 its own); citations of its devices by later devices: 3 (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
- Ivoclar Vivadent, Inc.: 4 (https://510kreport.com/company/ivoclar-vivadent)
- Zap Lasers, LLC: 2 (https://510kreport.com/company/zap-lasers)
- Ultradent Products, Inc.: 2 (https://510kreport.com/company/ultradent-products)
- Bisco, Inc.: 1 (https://510kreport.com/company/bisco)
- Den-Mat Corp.: 1 (https://510kreport.com/company/den-mat)
- Eele Laboratories, LLC: 1 (https://510kreport.com/company/eele-laboratories)
- Sdi Limited: 1 (https://510kreport.com/company/sdi)
- Danville Materials, Inc.: 1 (https://510kreport.com/company/danville-materials)

## Firms that cite its devices most
- Viax Dental Lab: 1 (https://510kreport.com/company/viax-dental-lab)
- Regulatory Technology Services, LLC: 1 (https://510kreport.com/company/regulatory-technology-services)
- Dentlight, Inc.: 1 (https://510kreport.com/company/dentlight)

## Its most-cited devices
- K103667: Sapphire ST Portable Diode Laser (2010), cited by 2
- K073483: Sapphire O/E Oral Examination System (2008), cited by 1

## Recent decisions
- K262252: MPa Max adhesive (Sep 24, 2026)
- K242097: DenMat Bulk Fill Composite (Oct 15, 2024)
- K162967: nuance UNIVERSAL (Mar 24, 2017)
- K143679: Nuance FLOW (May 1, 2015)
- K140537: TENURE4G (Aug 20, 2014)
- K110079: Spphine Plus STM 3W Diode Laser (Feb 10, 2011)
- K103667: Sapphire ST Portable Diode Laser (Dec 29, 2010)
- K081287: Sapphire Plasma Arc Dental Curing Light (Nov 21, 2008)

Source page: https://510kreport.com/company/den-mat-holdings