Manufacturer registered with FDA
iSonic Inc.
Chicago, IL, United States. Lists 4 dental device types with FDA across 1 registered establishment.
- Device types listed
- 4
- Brands and models
- 7
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1United States
Devices listed with FDA
What iSonic 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 |
|---|---|---|---|---|
| Suction Operatory UnitEBR · Class 1 | Suction & evacuation units | Maker | iSonic | 2020 |
| Over the Counter Denture CleanserEFT · Class 1 | Denture cleansers & adhesives | Maker | iSonic® AlignClean Ultrasonic Cleaning TabletiSonic® Green Natural Ultrasonic Denture CleanseriSonic® White Ultrasonic Denture Cleanser | 2015 |
| Powered ToothbrushJEQ · Class 1 | Toothbrushes | Maker | iSonicU-Smile | 2019 |
| Mechanical Denture CleanerJER · Class 1 | Denture cleansers & adhesives | Maker | iSonic® Ultrasonic Denture Retainer Cleaner | 2015 |
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 |
|---|---|---|
| ISONIC INC.FDA reg. 3011774865 | Chicago, IL, United States | Repacker / relabeler, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10049874). 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.