Manufacturer registered with FDA
Koncept Innovators, LLC
Myrtle Beach, SC, United States. Lists 2 dental device types with FDA across 1 registered establishment, and holds 2 510(k) clearances as applicant.
- Device types listed
- 2
- Brands and models
- 26
- 510(k) clearances
- 22020–2026
- Markets registered in
- 1United States
- Establishments
- 1United States
510(k) clearances per year, 2007–2026
Devices listed with FDA
What Koncept Innovators, LLC currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Jaw Repositioning DeviceLQZ · Class 2 | Anti-snoring & jaw-repositioning devices | Maker | Bright Guard Pro 2Dormiva Anti-Snoring Mouth GuardEliminator Pro 2Intelliguard ProSerenity Pro 2Somnos Anti-Snoring Mouth GuardSomnos Pro 2TranquilityTranquility Anti-Snoring Mouth GuardTranquility PRO 3 moreTranquility Pro 2Tranquility PRO 2 Anti-Snoring Mouth GuardTranquility PRO Anti-Snoring Mouth Guard | 2020 |
| Anti-Snoring DeviceLRK · Class 2 | Anti-snoring & jaw-repositioning devices | Maker | Bright Guard Pro 2Dormiva Anti-Snoring Mouth GuardEliminator Pro 2Intelliguard ProSerenity Pro 2Somnos Anti-Snoring Mouth GuardSomnos Pro 2TranquilityTranquility Anti-Snoring Mouth GuardTranquility PRO 3 moreTranquility Pro 2Tranquility PRO 2 Anti-Snoring Mouth GuardTranquility PRO Anti-Snoring Mouth Guard | 2020 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Koncept Innovators, LLC as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 14 May 2026 | K261134 | Dormiva Anti-Snoring Mouth Guard | LRK Anti-Snoring Device |
| 23 Nov 2020 | K201484 | Somnos Anti-Snoring Mouth Guard | LRK Anti-Snoring Device |
Some of these clearances are listed with FDA today by another company: Digital Dental Depot (1), Digital Dental Depot Limited (1), Xiamen Yizhou Imp. & Exp. Co., Ltd. (1).
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| Koncept Innovators, LLCFDA reg. 3010358861 | Myrtle Beach, SC, United States | Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10059662). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.