Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014314529

FEI Number

3014314529

Entity Name

Changzhou IVORIE Shengmei Packaging Technology Co.Ltd

City/State/Country

Changzhou Jiangsu, CN

Establishment Address

No.3, Xia Ming Road, Hengshanqiao Town, Economic Development District, Changzhou Jiangsu 213117, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Changzhou IVORIE Shengmei Packaging Technology Co.Ltd (Owner Number: 10056830)

Owner / Operator Contact Address

No.3, Xia Ming Road, Hengshanqiao Town, Economic Development District, Changzhou, CN-JS 213117, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Teeth Wipes,Brush Ups,Finger Brush,Oral Brush Ups Foam Strip Mouth Tray/Gel Prefilled Mouth Tray/ Bruxism mouth guard Thermoplastic Mouth Tray/Mouth Piece/Sports mouth guard/Teeth Whitening Mouth Tray Denture Cleansing Tablet Vitamin E Swab Anti Snore Belt/Chin Strap Belt/Snoring Vent/stop snoring tongue Stop Snoring Chin Strap/Anti Snore Jaw Supporter/Stop Snoring Solution Teeth whitening Led Light(MD666); Teeth Whitening Mouth Tray Led Light; Teeth Whitening Mouth Tray Light; Portable Teeth Whitening Light; Teeth Whitening Light 8led/16led; Teeth Whitening Accelerator; Plusma Light; Teeth Whitening Light; Smart Teeth Whitening Light; Teeth Whitening Lamp) HEAT SOURCE FOR BLEACHING TEETH (Teeth Whitening Mini Light; Mini Light 1led/5led; Teeth whitening Led Light 8led/16ledSmart Teeth Whitening Device; Water flosser/Oral Irrigator Dental Dam/Dental Gum Dam/ Gum Protector Gel/ Gingival Protection Gel Teeth Bleaching System/Teeth Bleaching Kit/Teeth Whitening Strips Teeth Whitening Pen/Empty Pen/Bleaching Pen/Teeth Whitener/Teeth Whitening Gel 3ml/5ml/10ml Coconut oil pulling; Coconut oil sachet, Oral care kit, Toothpaste PROFESSIONAL WHITENING GEL; Remineralization Gel/Desensitizing Gel/Teeth Whitening Kit/Teeth Whitening Home Kit Double Elastic Gel Strips/Dry Strips/Dissolving Strip; teeth whitening powder; charcoal teeth whitening powder Teeth Whitening System; Dual Barrel Gel, Double Barrel Gel, Dual Barrel Syring Gel, Double Barrel Syringe Gel;

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EFW	Toothbrush, Manual	Dental	Class 1	872.6855	2018-01-19
EHY	Tray, Impression, Preformed	Dental	Class 1	872.6880	2018-01-19
EFT	Cleanser, Denture, Over The Counter	Dental	Class 1	872.3520	2018-01-22
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2018-01-19
LWF	Dilator, Nasal	Ear, Nose, Throat	Class 1	874.3900	2018-01-19
EEG	Heat Source For Bleaching Teeth	Dental	Class 1	872.6475	2018-01-22
EFS	Unit, Oral Irrigation	Dental	Class 1	872.6510	2021-12-02
EIE	Dam, Rubber	Dental	Class 1	872.6300	2018-01-22
MAU	Eraser, Dental Stain	Dental	Class 1	872.6855	2018-01-22

Official Correspondent

Zhiyue Ding

US Agent Details

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

Related Public Records

Same Entity

Changzhou IVORIE Shengmei Packaging Technology 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
K973236	Procter & Gamble Co.	CREST TOOTHBRUSH WITH MICROSHIELD	1998-03-11
K902838	Denture Dynamic'S, Inc.	DENTURE DYNAMIC'S DENTURE MAGIC	1990-09-06
K844318	Pro Pulse, Inc.	ORAL IRRIGATION TIP	1984-11-23
K040797	Britesmile, Inc.	BRITESMILE MASKING CREAM	2004-04-02

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014314529. Last updated year: 2026. Please use registration number 3014314529 when referencing this establishment in official correspondence.