# Den Tek Oral Care, Inc.

- Location (FDA's records): Washington, DC
- FDA decisions: 8 (2007–2015): 8 510(k) clearances
- Product codes: OBR (6), MQC (1), EFW (1)
- Predicates its devices cite: 12 (6 its own); citations of its devices by later devices: 19 (6 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
- Power Products, Inc.-Splintek: 2 (https://510kreport.com/company/power-products-splintek)
- Placontrol, Inc.: 1 (https://510kreport.com/company/placontrol)
- Dental Concepts, LLC: 1 (https://510kreport.com/company/dental-concepts)
- Oral-B Laboratories: 1 (https://510kreport.com/company/oral-b-laboratories)
- Johnson & Johnson Consumer Products, Inc.: 1 (https://510kreport.com/company/johnson-johnson-consumer-products)

## Firms that cite its devices most
- Doc Brands, Inc.: 2 (https://510kreport.com/company/doc-brands)
- Ranir, LLC: 2 (https://510kreport.com/company/ranir)
- Medtech Products, Inc.: 2 (https://510kreport.com/company/medtech-products)
- International Profit Builders, Inc.: 1 (https://510kreport.com/company/international-profit-builders)
- Sleep Specialties, LLC: 1 (https://510kreport.com/company/sleep-specialties)
- Akervall Technologies, Inc.: 1 (https://510kreport.com/company/akervall-technologies)
- Bite Tech, Inc.: 1 (https://510kreport.com/company/bite-tech)
- Oralabs, Inc.: 1 (https://510kreport.com/company/oralabs)

## Its most-cited devices
- K072147: Den Tek Comfort Fit Nightguard (2007), cited by 6
- K063483: Den Tek Nightguard (2007), cited by 4
- K091660: Custom Comfort Nightguard Version 2 (2009), cited by 4
- K083400: Custom Comfort Nightguard (2008), cited by 2
- K151149: Ready-Fit (2015), cited by 2
- K081669: Improved Comfort-Fit Nightguard (2008), cited by 1

## Recent decisions
- K151149: Ready-Fit (Sep 30, 2015)
- K130186: Dentek Easy Brush with Fluoride (Jul 15, 2013)
- K123849: New Comfort-Fit Dental Guard (Jan 10, 2013)
- K091660: Custom Comfort Nightguard Version 2 (Jun 12, 2009)
- K083400: Custom Comfort Nightguard (Dec 11, 2008)
- K081669: Improved Comfort-Fit Nightguard (Jul 10, 2008)
- K072147: Den Tek Comfort Fit Nightguard (Aug 30, 2007)
- K063483: Den Tek Nightguard (Jan 23, 2007)

Source page: https://510kreport.com/company/den-tek-oral-care