Manufacturer registered with FDA
Smyles Above Innovations, Inc
Barrington, IL, United States. Lists 3 dental device types with FDA across 1 registered establishment.
- Device types listed
- 3
- Brands and models
- 6
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1United States
Devices listed with FDA
What Smyles Above Innovations, 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 |
|---|---|---|---|---|
| Dental BurEJL · Class 1 | Dental burs & diamonds | Lister | IrriGUIDE Seating BurIrriGUIDE Trimming Bur | 2024 |
| Dental FlossJES · Class 1 | Floss & interdental cleaners | Maker | The AutoFlosserThe AutoFlosser FLOSS | 2024 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | IrriGUIDE AdapterIrriGUIDE Surgical Guide | 2023 |
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 |
|---|---|---|
| Smyles Above Innovations, IncFDA reg. 3030228577 | Barrington, IL, United States | Contract manufacturer, Repacker / relabeler, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10089519). 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.