Manufacturer registered with FDA
Splintek Inc.
Lenexa, KS, United States. Lists 1 dental device type with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 1
- Brands and models
- 0
- 510(k) clearances
- 12025–2025
- Markets registered in
- 39 registrations outside the US
- Establishments
- 1United States
510(k) clearances per year, 2007–2026
Registered in 3 markets
Where regulators' registries name Splintek Inc. 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 | Splintek Inc. | 1 clearances | 2025–2025 | Below |
| European Union | EUDAMED | Manufacturer | Splintek, Inc. | 7 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Splintek, Inc. | 2 | — | 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 Splintek 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 |
|---|---|---|---|---|
| Anti-Snoring DeviceLRK · Class 2 | Anti-snoring & jaw-repositioning devices | Maker | — | 2026 |
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 |
|---|---|---|
| Splintek Inc.FDA reg. 3003460151 | Lenexa, KS, United States | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9047750). 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.