Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010585908

FEI Number

3010585908

Entity Name

Onuge Personal Care (Guangdong) Manufacturer Group Co., LTD.

City/State/Country

Guangzhou Guangdong, CN

Establishment Address

No. 28, Longhai Road, Huadu District, Guangzhou Guangdong 510800, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Onuge Personal Care(Guangdong)Manufacturer Group Co., LTD. (Owner Number: 10062230)

Owner / Operator Contact Address

No. 28, Longhai Road, Huadu District, Guangzhou, CN-GD 510800, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

BocaBella Natural Teeth Whitening Strips BocaBella Teeth Whitening U-wraps Teeth Whitening Powder Teeth Whitening Pen-TWP-01 Charcoal Teeth Whitening Powder Teeth Whitening Gel Teeth Whitening Home Kit Enlight Trading Inc. Teeth Whitening Kit Teeth Whitening Gel 2ml/ 3ml/ 5ml /10ml Teeth Whitening Pen Teeth Whitening System EEG Teeth Whitening Kit Dentiguard LED Teeth Whitening Kit Dentiguard LED Teeth whitening Kit BocaBella Natural Teeth Whitening Strips Teeth Whitening Strips Teeth Whitening Dry Strips Charcoal Teeth Whitening Strips Teeth Whitening Gel Strips Fitreno Teeth Whitening Strips-ONG-YT-01 CVSHealth Brilliant White Whitening Strips(Peach flavor) CVSHealth Brilliant White Whitening Strips(Coconut flavor) Dissolving Teeth Whitening Strips BocaBella Teeth Whitening U-wraps

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MAU	Eraser, Dental Stain	Dental	Class 1	872.6855	2020-01-10
EEG	Heat Source For Bleaching Teeth	Dental	Class 1	872.6475	2023-04-11
EHM	Strip, Polishing Agent	Dental	Class 1	872.6010	2022-04-16

Official Correspondent

Xiaoyi Xu

US Agent Details

James St WU Business: Humiss Inc. Email: fda-reg@humiss.com Phone: (720) 7595888

Related Public Records

Same Entity

Onuge Personal Care(Guangdong)Manufacturer Group Co., LTD.

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010585908. Last updated year: 2026. Please use registration number 3010585908 when referencing this establishment in official correspondence.