Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021388085

FEI Number

3021388085

Entity Name

SUZHOU RAMO MEDICAL INSTRUMENT CO., LTD.

City/State/Country

Suzhou City Jiangsu, CN

Establishment Address

No. 9 Wengzhuang Road, Shanghu Town, Changshu City, Suzhou City Jiangsu 215000, CN

Establishment Type(s)

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

Owner / Operator

Suzhou Ramo Medical Instrument Co., Ltd. (Owner Number: 10083781)

Owner / Operator Contact Address

No. 9 Wengzhuang Road, Shanghu Town, Changshu City, Suzhou City, CN-JS 215000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

EndoViewFiles Pro RCS Gold G Path Rotary File RCS Blue T Reciprocating File RCS Gold LT Rotary File RCS LT manual File RCS BlueT RCS Children File RCS Silver Rotary File RCS K File RCS R File Ultrasonic Niti File RCS Blue Rotary File RCS Spreader RCS Novel One RCS H File RCS Rainbow Ultra RCS C File RCS Rainbow One RCS ModiFile Snake System RCS Silver G Path Rotary File RCS Magic Path RCS Silver Orifice Opener File RCS Gold Rotary File RCS Retreatment File AP File RCS Gold Orifice Opener File RCS Blue Orifice Opener File RCS Silver Deciduous Rotary File RCS GoldLT Shape D RCS Rainbow ONE File RCS SCLEAN RCS Silver Retreatment Rotary File RCS GP FILE Endo Holder Rubber Dam Gutta Percha Point

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EKS	File, Pulp Canal, Endodontic	Dental	Class 1	872.4565	2021-12-17
EJB	Handle, Instrument, Dental	Dental	Class 1	872.4565	2024-12-16
EIE	Dam, Rubber	Dental	Class 1	872.6300	2024-12-16
EKM	Gutta-Percha	Dental	Class 1	872.3850	2024-12-16

Official Correspondent

No official correspondent registered.

US Agent Details

Charles Mack Business: IRC USA Email: ircfda@gmail.com Phone: (931) 6254938

Related Public Records

Same Entity

Suzhou Ramo Medical Instrument Co., Ltd.

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
K864976	Endo Technic Corp.	SOLUSET CALCIUM DEMINERALIZING SOLUTION	1987-02-27
K040797	Britesmile, Inc.	BRITESMILE MASKING CREAM	2004-04-02

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1215305	PULPDENT CORPORATION	Watertown, MA, US
3007284437	ORTHO ARCH COMPANY INC	Schaumburg, IL, US
2437780	CARGUS INT'L, INC.	CONGERS, NY, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3021388085. Last updated year: 2026. Please use registration number 3021388085 when referencing this establishment in official correspondence.