Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006650414

FEI Number

3006650414

Entity Name

KELLER LABORATORIES

City/State/Country

Fenton, MO, US

Establishment Address

160 Larkin Williams Ind Ct, Fenton, MO 63026, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

National Dentex LLC (Owner Number: 10040830)

Owner / Operator Contact Address

4400 PGA Blvd, Ste 700, Palm Beach Gardens, FL 33410, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K133390

PMA Number

N/A

All Registered Proprietary Names

TAP Thornton Adjustable Positioner ClearDream

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LRK	Device, Anti-Snoring	Dental	Class 2	872.5570	2012-12-12
LRK	Device, Anti-Snoring	Dental	Class 2	872.5570	2016-12-13

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

National Dentex LLC

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3010138699	NDX nSequence	Reno, NV, US
3004755100	ALBENSI DENTAL LAB	Irwin, PA, US
3002916277	GREEN DENTAL LAB	Heber Springs, AR, US
3012690648	NDX Paramount Dental Laboratory	Sacramento, CA, US
3005512166	NELSON DENTAL LAB	Rochester Hills, MI, US

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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3039643908	EMA-SLEEP INC	Bastrop, TX, US
3007108578	TRUE FUNCTION LABORATORY INC	La Mesa, CA, US
3006786034	Innovative Health Technologies (NZ) Limited	Dunedin Otago, NZ

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006650414. Last updated year: 2026. Please use registration number 3006650414 when referencing this establishment in official correspondence.