Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1058458

FEI Number

1000158594

Entity Name

CHEMLINK LABORATORIES, LLC.

City/State/Country

Kennesaw, GA, US

Establishment Address

3960 ROYAL DRIVE, SUITE 500, Kennesaw, GA 30144, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

Ecolab Inc (Owner Number: 9009921)

Owner / Operator Contact Address

1 Ecolab Place, Saint Paul, MN 55102, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FLG	Cleaner, Ultrasonic, Medical Instrument	General Hospital	Class 1	880.6150	2025-12-05
JER	Cleaner, Denture, Mechanical	Dental	Class 1	872.3530	2025-12-05

Official Correspondent

Bryan Davis

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Ecolab Inc

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3013545043	ECOLAB FOOD SAFETY SPECIALTIES INC.	Fort Worth, TX, US
3016690581	National Wiper Alliance	Swannanoa, NC, US

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-2025	Young Dental Manufacturing I, LLC	1	BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16 gallons of solution.

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1000355982	ARMSTRONG MANUFACTURING INCORPORATED	Mississauga Ontario, CA
3007697908	Novapharm Research Australia Pty Ltd	Rosebery New South Wales, AU
2183301	PATTERSON DENTAL SUPPLY, INC.	ST. PAUL, MN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1058458. Last updated year: 2026. Please use registration number 1058458 when referencing this establishment in official correspondence.