Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9615845

FEI Number

3003081210

Entity Name

RECO-DENT INTL. CO., LTD.

City/State/Country

NEW TAIPEI CITY, TW

Establishment Address

6F, No. 3 & 4F/6F, No.5, Pa De St., Su Lin Dist., NEW TAIPEI CITY 23857, TW

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

Reco-Dent International Co., Ltd. (Owner Number: 9035291)

Owner / Operator Contact Address

6F, No. 3 & 4F/6F, No.5, Pa De St., Su Lin Dist.,, New Taipei City, TW-NWT 23857, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Dental Diamond Instrument Prophylaxis Cup Abrasive Disk

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DZP	Instrument, Diamond, Dental	Dental	Class 1	872.4535	1998-10-15
EHK	Cup, Prophylaxis	Dental	Class 1	872.6290	2000-07-21
EHJ	Disk, Abrasive	Dental	Class 1	872.6010	2000-07-21

Official Correspondent

No official correspondent registered.

US Agent Details

Shu-Chen Cheng Business: ROC Chinese-European Industrial Research Society Email: ceirs.jen@msa.hinet.net Phone: (614) 5888168

Related Public Records

Same Entity

Reco-Dent International Co., Ltd.

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

View Entity Profile →

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3003444492	PRIMA DENTAL GROUP	GLOUCESTER Gloucestershire, GB

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9615845. Last updated year: 2026. Please use registration number 9615845 when referencing this establishment in official correspondence.