Randmark Dental Products, LLC
Country not established FDA establishment FEI 3009133124
- Devices
- 1
- Registrations
- FDA
- FDA recalls
- 0
What Randmark Dental Products, LLC makes
Randmark Dental Products, LLC manufactures custom-fit oral appliances, including the Freeway Comfort Bite Guard, designed to protect teeth and reduce jaw strain during sleep or clenching.
The company’s products are classified as Class II devices under FDA regulations and are listed via the 510(k) pathway. The manufacturer is based in the United States.
Catalogue
Freeway Comfort Bite Guard Ref K110468
510(k) 510(k)
Company details
- FDA FEI number
- 3009133124
- Address
- 284 Elkins Ln, Lusby, MD, 20657
Frequently asked questions
How many devices does RANDMARK DENTAL PRODUCTS, LLC have in the registry?
The registry currently lists 1 device for RANDMARK DENTAL PRODUCTS, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list RANDMARK DENTAL PRODUCTS, LLC's devices?
Among its 1 most recently registered device, RANDMARK DENTAL PRODUCTS, LLC has devices listed in FDA 510(k) (1 device).
What are the newest devices from RANDMARK DENTAL PRODUCTS, LLC in the registry?
The most recently registered devices listed for RANDMARK DENTAL PRODUCTS, LLC include FREEWAY COMFORT BITE GUARD.