Manufacturer registered with FDA
X-NAV Technologies, LLC.
Lansdale, PA, United States. Lists 4 dental device types with FDA across 1 registered establishment, and holds 6 510(k) clearances as applicant.
- Device types listed
- 4
- Brands and models
- 27
- 510(k) clearances
- 62015–2026
- Markets registered in
- 1181 registrations outside the US
- Establishments
- 1United States
510(k) clearances per year, 2007–2026
Registered in 11 markets
Where regulators' registries name X-NAV Technologies, 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 | X-NAV Technologies, LLC. | 6 clearances | 2015–2026 | Below |
| Canada | Health Canada | Registration holder | X-NAV TECHNOLOGIES, LLC. | 39 | 2015–2024 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | X-Nav Technologies, LLC | 21 | — | Pure Global AI |
| Australia | TGA | Manufacturer | X-Nav Technologies LLC | 4 | 2015–2025 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | X-Nav Technologies, LLC | 4 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | X-Nav TechnologiesX-NAV Technologies, LLC | 3 | — | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | X-Nav Technologies, LLC | 3 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | X-NAV Technologies, LLCX-NAV Technologies, LLC. | 3 | 2017–2020 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | X-Nav Technologies, LLC | 2 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | X-NAV TECHNOLOGIES, LLC | 1 | 2022–2022 | Pure Global AI |
| Hong Kong | MDD | Manufacturer | X-NAV TECHNOLOGIES, LLC | 1 | 2025–2025 | 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 X-NAV Technologies, 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 |
|---|---|---|---|---|
| Dental Stereotaxic InstrumentPLV · Class 2 | — | Maker | EDX Bone ScrewEDX Tracker ArmIconiXIconiX AIStraight CutsToolTraceX-GuideX-Guide (X-Mark)X-Guide IconiX AIX-Guide NXT 2 moreX-Guide Surgical Navigation SystemX-Guide System | 2015 |
| Dental Navigation SystemQRY · Class 2 | — | Maker | IconiXIconiX AIStraight CutsToolTraceX-GuideX-Guide IconiX AIX-Guide NXTX-Guide Surgical Navigation SystemX-Guide System | 2022 |
| Intraosseous Fixation ScrewDZL · Class 2 | Maxillofacial plates & screws | Maker | EDX Bone ScrewEDX Tracker ArmX-Guide Surgical Navigation System | 2020 |
| Computer Assisted Design and Manufacturing (Cad/Cam) of Dental Restorations Optical Impression SystemNOF · Class 2 | Intraoral scanners | Maker | FastMapFastMap Navigated PhotogrammetryX-Guide FastMap | 2024 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names X-NAV Technologies, LLC. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 28 Aug 2026 | K253954 | X-Guide Surgical Navigation System | QRY Dental Navigation System |
| 21 Feb 2024 | K232148 | X-Guide Surgical Navigation System | QRY Dental Navigation System |
| 1 Feb 2022 | K211701 | X-Guide® Surgical Navigation System | QRY Dental Navigation System |
| 21 May 2020 | K200662 | X-Guide® Surgical Navigation System | PLV Dental Stereotaxic Instrument |
| 3 Feb 2020 | K192579 | X-Guide Surgical Navigation System | PLV Dental Stereotaxic Instrument |
| 8 Oct 2015 | K150222 | X-Guide Surgical Navigation System | PLV Dental Stereotaxic Instrument |
Some of these clearances are listed with FDA today by another company: Nobel Biocare Services AG (2).
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| X-NAV TECHNOLOGIES, LLC.FDA reg. 3011764595 | Lansdale, PA, United States | Complaint file establishment, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10049672). 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.