Data / Medical devices / United States / Koncept Innovators, LLC
Koncept Innovators, LLC: FDA-registered device maker in Myrtle Beach, SC, United States, 3 510(k) clearances
Koncept Innovators, LLC is registered with the FDA (registration 3010358861) in Myrtle Beach, SC, United States. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated May 14, 2026. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3010358861
- Address
- 1619 Executive Ave, Myrtle Beach, SC, United States, 29577
- Owner or operator
- Koncept Innovators, LLC (10059662)
- Roles
- Specification developer
- First device listed
- February 8, 2019
- Registered through
- 2026
- Brand names listed
- Bright Guard, Bright Guard 2, Bright Guard Pro 2, Dormiva Anti-Snoring Mouth Guard, Eliminator, Eliminator Pro, Eliminator Pro 2, Intelliguard and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Anti-Snoring | LRK | 2 | Specification developer | accessdata.fda.gov |
| Device, Jaw Repositioning | LQZ | 2 | Specification developer | accessdata.fda.gov |
| Mouthguard, Over-The-Counter | OBR | U | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 14, 2026 | K261134 | Dormiva Anti-Snoring Mouth Guard | LRK | Substantially Equivalent | Koncept Innovators, Inc. | accessdata.fda.gov |
| November 23, 2020 | K201484 | Somnos Anti-Snoring Mouth Guard | LRK | Substantially Equivalent | Koncept Innovators, LLC | accessdata.fda.gov |
| January 18, 2019 | K181099 | Bright Guard | OBR | Substantially Equivalent | Koncept Innovators, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Device, Anti-Snoring
- All makers of Device, Jaw Repositioning
- All makers of Mouthguard, Over-The-Counter
Updated May 14, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.