SOLITE WELLBEING USA INC.

FDA Device Registration & Listing · Austin, TX, US · Registration 3027315350

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
3027315350
FEI Number
3027315350
Entity Name
SOLITE WELLBEING USA INC.
City/State/Country
Austin, TX, US
Establishment Address
815 BRAZOS ST, Austin, TX 78701, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Solite Wellbeing USA Inc. (Owner Number: 10088008)
Owner / Operator Contact Address
815 BRAZOS ST, Austin, TX 78701, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

bixdo BT01 Whitening Toothbrush Head for bixdo W60 Blue Light Whitening Electric Toothbrush bixdo W60 Blue Light Whitening Electric Toothbrush bixdo NZ-P01 Magnetic Standard Tip bixdo M30 Ultra Compact Cordless Water Dental Flosser bixdo P50 Pro Smart Cordless Water Dental Flosser bixdo K30 Smart Cordless Water Dental Flosser bixdo A30 Pro Ultra Compact Water Dental Flosser bixdo NZ-P01 Magnetic Plaque Tip bixdo A30 Ultra Compact Water Dental Flosser bixdo M60 Smart Warm Water Dental Flosser bixdo P50 Smart Cordless Water Dental Flosser bixdo NZ-P01 Magnetic Orthodontic Tip bixdo P10 Smart Cordless Oral lrrigator bixdo NZ-A01 Soft Tip bixdo NZ-A01 Standard Tip bixdo NZ- bixdo A01 Orthodontic Tip FLOSSOM SkinPilot FLOSSOM FR100 RF Beauty Device Pro FLOSSOM FR200 RF Beauty Device Pro

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
JEQ Toothbrush, Powered Dental Class 1 872.6865 2024-12-18
EFS Unit, Oral Irrigation Dental Class 1 872.6510 2023-05-15
ISA Massager, Therapeutic, Electric Physical Medicine Class 1 890.5660 2025-04-29

Official Correspondent

Tiffany Li

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Solite Wellbeing USA Inc.
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
K844318 Pro Pulse, Inc. ORAL IRRIGATION TIP 1984-11-23

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3027315350. Last updated year: 2026. Please use registration number 3027315350 when referencing this establishment in official correspondence.
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