Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014610038

FEI Number

3014610038

Entity Name

HISMILE PTY LTD

City/State/Country

BURLEIGH WATERS Queensland, AU

Establishment Address

225-229 BURLEIGH CONNECTION ROAD, BURLEIGH WATERS Queensland 4220, AU

Establishment Type(s)

Foreign Private Label Distributor,Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

HiSmile Pty Ltd (Owner Number: 10057830)

Owner / Operator Contact Address

225-229 BURLEIGH CONNECTION ROAD, BURLEIGH WATERS, AU-QLD 4220, AU

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Hismile Waxed Floss HISMILE TOOTHBRUSH Hismile LED Teeth Whitening Device, Sona Teeth Whitening Device (new), Smilehero Teeth Whitening Kit Hismile VIO405 Device, Hismile Professional Accelerator Hismile Electric Toothbrush

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JES	Floss, Dental	Dental	Class 1	872.6390	2021-08-18
EFW	Toothbrush, Manual	Dental	Class 1	872.6855	2023-07-23
EEG	Heat Source For Bleaching Teeth	Dental	Class 1	872.6475	2018-05-31
JEQ	Toothbrush, Powered	Dental	Class 1	872.6865	2024-01-08

Official Correspondent

Trent Heckel

US Agent Details

FDAIMPORTS.COM LLC Email: registration@fdaimports.com Phone: (410) 2202800

Related Public Records

Same Entity

HiSmile Pty 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
K882164	Arthur Blank & Co., Inc.	FLOSS CARD	1988-06-10
K973236	Procter & Gamble Co.	CREST TOOTHBRUSH WITH MICROSHIELD	1998-03-11

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014610038. Last updated year: 2026. Please use registration number 3014610038 when referencing this establishment in official correspondence.