Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011774865

FEI Number

3011774865

Entity Name

ISONIC INC.

City/State/Country

Chicago, IL, US

Establishment Address

2243 S THROOP ST, Chicago, IL 60608, US

Establishment Type(s)

Repack or Relabel Medical Device,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

iSonic Inc. (Owner Number: 10049874)

Owner / Operator Contact Address

2243 S. Throop St., Chicago, IL 60608, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

iSonic iSonic® Ultrasonic Denture Retainer Cleaner iSonic® Ultrasonic Cleaner iSonic® Ultrasonic C-PAP Cleaner iSonic, Resurge, StatClean, Z3 (Benco) iSonic U-Smile iSonic iSonic® Green Natural Ultrasonic Denture Cleanser iSonic® White Ultrasonic Denture Cleanser iSonic® AlignClean Ultrasonic Cleaning Tablet

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HLH	Pupillometer, Manual	Ophthalmic	Class 1	886.1700	2019-07-24
JER	Cleaner, Denture, Mechanical	Dental	Class 1	872.3530	2015-08-18
FLG	Cleaner, Ultrasonic, Medical Instrument	General Hospital	Class 1	880.6150	2015-08-18
JDX	Instrument, Surgical, Sonic And Accessory/Attachment	Orthopedic	Class 2	888.4580	2020-02-07
JEQ	Toothbrush, Powered	Dental	Class 1	872.6865	2019-07-24
HLM	Instrument, Measuring, Lens, Ac-Powered	Ophthalmic	Class 1	886.1425	2019-07-24
EFT	Cleanser, Denture, Over The Counter	Dental	Class 1	872.3520	2015-08-18

Official Correspondent

Ten Chu

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

iSonic Inc.

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
K902838	Denture Dynamic'S, Inc.	DENTURE DYNAMIC'S DENTURE MAGIC	1990-09-06

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.

Similar Registrations

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3004441848	S4OPTIK LLC	Jacksonville, FL, US
2031962	STALLION MEDICAL, INC.	SAN DIEGO, CA, US
3005771344	TREVI TECHNOLOGY	Columbus, OH, US
3004784203	TOWA MEDICAL INSTRUMENTS CO.,LTD.	Nakano-shi Nagano, JP
3009515444	GINO OPTICAL (SHANGHAI) CO., LTD.	Shanghai, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011774865. Last updated year: 2026. Please use registration number 3011774865 when referencing this establishment in official correspondence.