Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010358861

FEI Number

3010358861

Entity Name

Koncept Innovators, LLC

City/State/Country

Myrtle Beach, SC, US

Establishment Address

1619 Executive Ave, Myrtle Beach, SC 29577, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Koncept Innovators, LLC (Owner Number: 10059662)

Owner / Operator Contact Address

1619 Executive Ave, Myrtle Beach, SC 29577, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K181099

PMA Number

N/A

All Registered Proprietary Names

Tranquility PRO 2 Anti-Snoring Mouth Guard Tranquility PRO Bright Guard Pro 2 Tranquility Eliminator Pro 2 Tranquility Pro 2 Somnos Pro 2 Tranquility Anti-Snoring Mouth Guard Tranquility PRO Anti-Snoring Mouth Guard Intelliguard Pro Serenity Pro 2 Somnos Anti-Snoring Mouth Guard Eliminator Pro 2 Eliminator Pro Bright Guard 2 Bright Guard Intelliguard Eliminator Serenity Bright Guard Pro 2

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LRK	Device, Anti-Snoring	Dental	Class 2	872.5570	2020-12-03
LQZ	Device, Jaw Repositioning	Dental	Class 2	872.5570	2020-12-03
OBR	Mouthguard, Over-The-Counter	Unknown	Class U	N/A	2019-02-08

Official Correspondent

Sylvan Newby

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Koncept Innovators, LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K122391	Medtronic Xomed, Inc.	MEDTRONIC XOMED, INC.	2013-01-10

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010358861. Last updated year: 2026. Please use registration number 3010358861 when referencing this establishment in official correspondence.