Manufacturer registered with FDA
OrVance LLC
Caledonia, MI, United States. Lists 4 dental device types with FDA across 1 registered establishment.
- Device types listed
- 4
- Brands and models
- 4
- 510(k) clearances
- 0as applicant
- Markets registered in
- 21 registrations outside the US
- Establishments
- 1United States
Registered in 2 markets
Where regulators' registries name OrVance LLC as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | OrVance LLC | 4 device types | — | Below |
| Australia | TGA | Manufacturer | Orvance LLC | 1 | 2018–2018 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What OrVance LLC currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Over the Counter Denture CleanserEFT · Class 1 | Denture cleansers & adhesives | Maker | OrVance Retainer Cleaner | 2022 |
| Manual ToothbrushEFW · Class 1 | Toothbrushes | Maker | OrVance Superior Clean Interdental Brushes | 2024 |
| Intraoral Dental WaxEGD · Class 1 | — | Maker | OrVance OrthoDots, OrVance Aligner Pontics | 2015 |
| Dental FlossJES · Class 1 | Floss & interdental cleaners | Maker | OrVance Braces Flosser, Braces Flosser | 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 |
|---|---|---|
| ORVANCE, LLCFDA reg. 3012047097 | Caledonia, MI, United States | Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10050000). 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.