STI-IR CO., LTD

FDA Device Registration & Listing · Higashi Osaka, JP · Registration 3010310321

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
3010310321
FEI Number
3010310321
Entity Name
STI-IR CO., LTD
City/State/Country
Higashi Osaka, JP
Establishment Address
4-6-29 Wakaehigashi-machi, Higashi Osaka 5780935, JP
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device
Owner / Operator
STI-IR (Owner Number: 10043341)
Owner / Operator Contact Address
4-6-29 Wakaehigashi-machi, Higashi Osaka, JP-27 5780935, JP
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Manual Toothbrush

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
EFW Toothbrush, Manual Dental Class 1 872.6855 2013-02-06

Official Correspondent

No official correspondent registered.

US Agent Details

Mark Gordon Email: Mark.W.Gordon@outlook.com Phone: (920) 6019045

Related Public Records

Same Entity

STI-IR
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
K973236 Procter & Gamble Co. CREST TOOTHBRUSH WITH MICROSHIELD 1998-03-11

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010310321. Last updated year: 2026. Please use registration number 3010310321 when referencing this establishment in official correspondence.
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