Manufacturer registered with FDA
Invisian Medical LLC
Prairie Village, KS, United States. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 1
- 510(k) clearances
- 0as applicant
- Markets registered in
- 21 registrations outside the US
- Establishments
- 1United States
Registered in 2 markets
Where regulators' registries name Invisian Medical 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 | Invisian Medical LLC | 1 device types | — | Below |
| Brazil | ANVISA | Manufacturer | INVISIAN MEDICAL, 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 Invisian Medical 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 |
|---|---|---|---|---|
| Intraoral Wire Lock and LigatureDYX · Class 2 | — | Maker | Minne Ties Agile MMF | 2022 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
Invisian Medical LLC lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Summit Medical, LLC (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 11 Apr 2017 | K162046 | MINNE TIES MMF Suture System | Summit Medical, LLC | DYX Intraoral Wire Lock and Ligature |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| INVISIAN MEDICAL LLCFDA reg. 3023158661 | Prairie Village, KS, United States | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10085373). 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.