TOMY International

FDA Device Registration & Listing · Dyersville, IA, US · Registration 3006852457

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3006852457
FEI Number
3006852457
Entity Name
TOMY International
City/State/Country
Dyersville, IA, US
Establishment Address
2021 9TH ST. S.E., Dyersville, IA 52040, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198
Owner / Operator
TOMY International, Inc. (Owner Number: 9086544)
Owner / Operator Contact Address
2021 9th Street S.E., Dyersville, IA 52040, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Manual Toothbrush Dispenser, Liquid Medication Multi-Use Digital Thermometer Liquid Filled Teether Y7797 ARC BEAR ICE WRAP Y7789 ARC Ice Pack P17498 Gel Pack

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
EFW Toothbrush, Manual Dental Class 1 872.6855 2022-12-07
KYX Dispenser, Liquid Medication General Hospital Class 1 880.6430 2022-12-07
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2015-07-30
KKO Ring, Teething, Fluid-Filled Dental Class 2 872.5550 2022-12-07
IME Pack, Hot Or Cold, Reusable Physical Medicine Class 1 890.5700 2018-06-04

Official Correspondent

Kenneth Li

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

TOMY International, 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
1217805 TOMY International, Inc. Canton, MA, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K973236 Procter & Gamble Co. CREST TOOTHBRUSH WITH MICROSHIELD 1998-03-11
K010462 Avita Corporation AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES) 2001-04-11
K760421 Arbrook Mfg. Corp. THERMOMETER, SURVALENT-ELECTRONIC 1976-08-23
K813409 Yellow Springs Instrument Co., Inc. MODEL 2100 DUAL-DISPLAY TELE-THERMOMETER 1981-12-18
K830039 Science Development Corp. SDC RECTAL TEMP. PROBE PRODUCT #1020 1983-02-23

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3043840120 CURIDENT, LLC Boca Raton, FL, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006852457. Last updated year: 2026. Please use registration number 3006852457 when referencing this establishment in official correspondence.
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