Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006691310

FEI Number

3006691310

Entity Name

SHIKEN CO.,LTD.

City/State/Country

Osaka, JP

Establishment Address

2-5-6,Terada-cho Tennoji-ku,Osaka, Osaka 543-0045, JP

Establishment Type(s)

Repack or Relabel Medical Device,Foreign Private Label Distributor,Develop Specifications But Do Not Manufacture At This Facility,Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

SHIKEN Co.,Ltd. (Owner Number: 10024612)

Owner / Operator Contact Address

2-5-6,Terada-cho, Tennoji-ku,Osaka, Osaka-shi, JP-27 543-0045, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Soladey Rhythm 2

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MMD	Toothbrush, Ionic, Battery-Powered	Dental	Class 1	872.6865	2021-06-09

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar corp Email: David.Lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

SHIKEN 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 3006691310. Last updated year: 2026. Please use registration number 3006691310 when referencing this establishment in official correspondence.