UNITED DENTAL CHANGZHOU

FDA Device Registration & Listing · Changzhou Jiangsu, CN · Registration 3015526995

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3015526995
FEI Number
3015526995
Entity Name
UNITED DENTAL CHANGZHOU
City/State/Country
Changzhou Jiangsu, CN
Establishment Address
B1, C1, D2, F2, No. 9 Changyang Road, West Taihu Science and Technology Industrial Park, Changzhou Jiangsu 213145, CN
Establishment Type(s)
Manufacture Medical Device,Export Device to the United States But Perform No Other Operation on Device
Owner / Operator
United Dental Changzhou (Owner Number: 10062136)
Owner / Operator Contact Address
B1, C1, D2, F2, No. 9 Changyang Road, West Taihu Science and Technology Industrial Park, Changzhou, CN-JS 213145, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Orthodontic metal Brackets, Orthodontic metal self ligating Brackets Irrigation needles Orthodontic Expansion Screws Orthodontic Stainless steel Wires, Orthodontic Niti Wires Rotary files/Root canal files, Hand use files/Manual files, Sterile Root Canal Files Irrigation needles Bondent Instrument Retrieval Kit Plugger

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
EJF Bracket, Metal, Orthodontic Dental Class 1 872.5410 2019-12-22
EFS Unit, Oral Irrigation Dental Class 1 872.6510 2019-12-23
DYJ Retainer, Screw Expansion, Orthodontic Dental Class 1 872.5410 2020-01-18
DZC Wire, Orthodontic Dental Class 1 872.5410 2019-12-22
DZA Drill, Dental, Intraoral Dental Class 1 872.4130 2019-12-22
EIC Syringe, Periodontic, Endodontic, Irrigating Dental Class 1 872.4565 2020-01-18
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2020-01-18
EKR Plugger, Root Canal, Endodontic Dental Class 1 872.4565 2019-12-23

Official Correspondent

Yue Wu

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

United Dental Changzhou
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
K844318 Pro Pulse, Inc. ORAL IRRIGATION TIP 1984-11-23
K112640 Ormco Corp. HYPERELASTIC WIRE 2011-11-16

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3023443842 HENAN BAISTRA MEDICAL DEVICES LIMITED Zhengzhou Henan, CN
3012232878 SUNSTAR TRADING INTERNATIONAL LIMITED Kowloon Hong Kong, CN
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015526995. Last updated year: 2026. Please use registration number 3015526995 when referencing this establishment in official correspondence.
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