Manufacturer registered with FDA
Solite Wellbeing USA Inc.
Austin, TX, United States. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 17
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1United States
Devices listed with FDA
What Solite Wellbeing USA Inc. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Oral Irrigation UnitEFS · Class 1 | Oral irrigators | Maker | bixdo A30 Pro Ultra Compact Water Dental Flosserbixdo A30 Ultra Compact Water Dental Flosserbixdo K30 Smart Cordless Water Dental Flosserbixdo M30 Ultra Compact Cordless Water Dental Flosserbixdo M60 Smart Warm Water Dental Flosserbixdo NZ- bixdo A01 Orthodontic Tipbixdo NZ-A01 Soft Tipbixdo NZ-A01 Standard Tipbixdo NZ-P01 Magnetic Orthodontic Tipbixdo NZ-P01 Magnetic Plaque Tip 4 morebixdo NZ-P01 Magnetic Standard Tipbixdo P10 Smart Cordless Oral lrrigatorbixdo P50 Pro Smart Cordless Water Dental Flosserbixdo P50 Smart Cordless Water Dental Flosser | 2023 |
| Powered ToothbrushJEQ · Class 1 | Toothbrushes | Maker | bixdo BT01 Whitening Toothbrush Head for bixdo W60 Blue Light Whitening Electric Toothbrushbixdo W30 Blue Light Whitening Electric Toothbrushbixdo W60 Blue Light Whitening Electric Toothbrush | 2024 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| SOLITE WELLBEING USA INC.FDA reg. 3027315350 | Austin, TX, United States | Complaint file establishment, Manufacturer, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10088008). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.