Koncept Innovators, LLC
Country not established FDA establishment FEI 3010358861
- Devices
- 3
- Registrations
- FDA
- FDA recalls
- 0
What Koncept Innovators, LLC makes
Koncept Innovators, LLC manufactures oral appliance devices designed to address sleep-related breathing disorders, including the Dormiva Anti-Snoring Mouth Guard, Bright Guard, and Somnos Anti-Snoring Mouth Guard. These products are intended to reposition the jaw and tongue to improve airway patency during sleep.
The company’s portfolio includes devices regulated as Class II and Class U under FDA oversight, with submissions recorded in the 510(k) clearance pathway. These products are listed in the U.S. regulatory database.
Catalogue
Dormiva Anti-Snoring Mouth Guard Ref K261134
510(k) 510(k)Bright Guard Ref K181099
510(k) 510(k)Somnos Anti-Snoring Mouth Guard Ref K201484
510(k) 510(k)
Company details
- FDA FEI number
- 3010358861
- Address
- 1619 Executive Ave, Myrtle Beach, SC, 29577
Frequently asked questions
How many devices does Koncept Innovators, LLC have in the registry?
The registry currently lists 3 devices for Koncept Innovators, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Koncept Innovators, LLC's devices?
Among its 3 most recently registered devices, Koncept Innovators, LLC has devices listed in FDA 510(k) (3 devices).
What risk classes do Koncept Innovators, LLC's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Koncept Innovators, LLC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Koncept Innovators, LLC in the registry?
The most recently registered devices listed for Koncept Innovators, LLC include Dormiva Anti-Snoring Mouth Guard, Bright Guard and Somnos Anti-Snoring Mouth Guard.