Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015142372

FEI Number

3015142372

Entity Name

BETHEL CO., LTD.

City/State/Country

Ishioka Ibaraki, JP

Establishment Address

3-11, Aragane, Ishioka Ibaraki 315-0021, JP

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer),Foreign Private Label Distributor

Owner / Operator

Bethel Co., Ltd. (Owner Number: 10092179)

Owner / Operator Contact Address

3-11, Aragane, Ishioka, JP-08 315-0021, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Tip 21G Bent Irri-Tip 25 double side vent Tip 25G Straight Tip 25G Bent Tip 25G Long Bent Irri-Tip 30 double side vent Tip 22G Curve Tip 21G Bent75 Irri-Tip 27 double side vent Tip 21G Long Bent Tip 27G Bent Tip 27G Straight Tip 21G Straight Tip 25G Long Straight Tip 21G Long Straight

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EIC	Syringe, Periodontic, Endodontic, Irrigating	Dental	Class 1	872.4565	2024-12-12

Official Correspondent

Saori Kitano

US Agent Details

Stephan Toupin Business: Dawa Medical LLC, Email: stoupin@dawamedical.com Phone: (305) 5999373

Related Public Records

Same Entity

Bethel Co., Ltd.

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015142372. Last updated year: 2026. Please use registration number 3015142372 when referencing this establishment in official correspondence.