Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3030531648

FEI Number

3030531648

Entity Name

CHANGSHA NICE MEDICAL INSTRUMENT LIMITED COMPANY

City/State/Country

Changsha Hunan, CN

Establishment Address

No.501, Building 9, Jinrong tongxin Industry, Changsha High-tech Development Zone, Hunan, China, Changsha Hunan 410200, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Changsha Nice Medical Instrument Limited Company (Owner Number: 10089775)

Owner / Operator Contact Address

No.501, Building 9, Jinrong tongxin Industry, Changsha High-tech Development Zone, Hunan, China, Changsha, CN-HN 410200, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Niceortho HOOK, SURGICAL, GENERAL & PLASTIC SURGERY Niceortho Spring Niceortho Orthodontic Attachments Niceortho Noninvasive Traction Component Niceortho Band, Orthodontic Niceortho Orthodontic Instrument, Climp Niceortho Clamp, Wire, Orthodontic Niceortho Metal Ordinary Bracket Niceortho Dental Opener Niceortho Crimp Hook Niceortho Anchor, Preformed Niceortho Lapping Tool Kit Niceortho TUBE, ORTHODONTIC Niceortho Band, elastic, orthodontic Niceortho Dental Burs Niceortho Dental Impression Tray

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GDG	Hook, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2024-01-08
ECO	Spring, Orthodontic	Dental	Class 1	872.5410	2024-01-08
KQZ	Component, Traction, Non-Invasive	Orthopedic	Class 1	888.5890	2024-01-08
DYO	Band, Material, Orthodontic	Dental	Class 1	872.5410	2024-01-08
ECN	Clamp, Wire, Orthodontic	Dental	Class 1	872.5410	2024-01-08
EJF	Bracket, Metal, Orthodontic	Dental	Class 1	872.5410	2024-01-08
EMJ	Elevator, Surgical, Dental	Dental	Class 1	872.4565	2024-01-08
EJX	Anchor, Preformed	Dental	Class 1	872.3130	2025-12-15
NYG	Lapping Tool Kit	Dental	Class 1	872.4565	2025-12-15
DZD	Tube, Orthodontic	Dental	Class 1	872.5410	2024-01-08
ECI	Band, Elastic, Orthodontic	Dental	Class 1	872.5410	2024-01-08
EJL	Bur, Dental	Dental	Class 1	872.3240	2024-01-08
EHY	Tray, Impression, Preformed	Dental	Class 1	872.6880	2024-01-08

Official Correspondent

Yanbo Gao

US Agent Details

Jun Peng Business: P&L Scientific Inc. Email: jpeng@plscientificinc.com Phone: (305) 3456018

Related Public Records

Same Entity

Changsha Nice Medical Instrument Limited Company

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
K894358	Ormco Corp.	LUMINA ORTHODONTIC BRACKET	1989-09-15
K925012	American Orthodontics	PLASTIC CHAIN	1993-09-13

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0012-2012	Biomet Microfixation, Inc.	1	Biomet Microfixation outer packaging labeled in part:"REF: SP-2411*RUBBER BAND, LATEX FREE SMALL, HEAVY, 300/PACKAGE 4MM, (3/16" INNER DIAMETER) NON LATEX ELASTICS LOT 307850DISTRIBUTED BY: BIOMET MICROFIXATION 1520 Tradeport Drive, Jacksonville, FL 32218 USA www.biometmicrofixation.com." Inner Vendor/Manufacturer Label labeled in part:"H4 Elastics 4mm (3/16") Heavy 4 oz. REF 11-102-04Manufactured for DENTSPLY GAC INTERNATIONAL DENTSPLY INTERNATIONAL, INC. Phone 631-419-1700 Fax 631-419-1599 355 Knickerbocker Avenue Bohemia NY 11716 USAMediMark Europe BP2332 F-38033 Grenoble Cedex 2. FranceLOT 82936-32 QTY:100 pk use by 2012-07 Made in USA ISSUED DATE 2009-04 GN**" Elastic bands used as elastomeric ties for ligation that facilitate treatment of fracture of the mandible and maxilla. They are commonly used with braces or arch bar wire.

Similar Registrations

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3030531648. Last updated year: 2026. Please use registration number 3030531648 when referencing this establishment in official correspondence.