Manufacturer registered with FDA
Dental Imaging Technologies Corporation
Quakertown, PA, United States. Lists 8 dental device types with FDA across 1 registered establishment, and holds 2 510(k) clearances as applicant.
- Device types listed
- 8
- Brands and models
- 24
- 510(k) clearances
- 22023–2026
- Markets registered in
- 513 registrations outside the US
- Establishments
- 1United States
510(k) clearances per year, 2007–2026
Registered in 5 markets
Where regulators' registries name Dental Imaging Technologies Corporation 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 | Dental Imaging Technologies Corporation | 2 clearances | 2023–2026 | Below |
| Israel | AMAR | Manufacturer | Dental Imaging Technologies Corporation | 6 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | DENTAL IMAGING TECHNOLOGIES CORPORATION | 5 | 2013–2025 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | DENTAL IMAGING TECHNOLOGIES CORPORATION | 1 | 2022–2022 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | DENTAL IMAGING TECHNOLOGIES CORPORATION | 1 | 2023–2023 | 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 Dental Imaging Technologies Corporation currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Extraoral with Timer X-Ray UnitEHD · Class 2 | Dental X-ray units | Maker | NOMAD Pro 2NOMAD Pro 3 | 2020 |
| Digital Extraoral Source X-Ray SystemMUH · Class 2 | Dental X-ray units | Maker | DEXIS IXS Size 1DEXIS IXS Size 1 Intraoral SensorDEXIS IXS Size 2DEXIS IXS Size 2 Intraoral SensorDEXIS Ti2 Intraoral SensorDexis Titanium | 2019 |
| X-Ray Film HolderEGZ · Class 1 | — | Maker | Imaging Sensor Holder | 2010 |
| X-Ray Beam AlignerEHA · Class 1 | — | Maker | Alignment Bars | 2015 |
| Operative Dental UnitEIA · Class 1 | Dental chairs & operative units | Maker | DEXcam4 HD | 2015 |
| Computer Assisted Design and Manufacturing (Cad/Cam) of Dental Restorations Optical Impression SystemNOF · Class 2 | Intraoral scanners | Maker | DEXIS ImprevoDEXIS IS 3700DEXIS IS 3800DEXIS IS 3800WIOS Scanner Tips | 2021 |
| Dental Computed Tomography X-RayOAS · Class 2 | Dental CBCT | Maker | i-CAT FLX V-Seriesi-CAT FLX V10i-CAT FLX V17i-CAT FLX V8OP 3D Vision V10OP 3D Vision V17OP 3D Vision V8 | 2017 |
| Orthodontic SoftwarePNN · Class 2 | Dental design & orthodontic software | Maker | CS Model+ | 2022 |
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 Dental Imaging Technologies Corporation as the applicant.
Also lists devices cleared under other names
Dental Imaging Technologies Corporation 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: Carestream Dental LLC (1), KaVo North America (1), Aribex (1), Imaging Sciences International (1), WinUs Technology Co., Ltd. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 2 Apr 2020 | K193390 | CS Model+ | Carestream Dental LLC | PNN Orthodontic Software |
| 18 Dec 2017 | K172918 | DEXIS Titanium, KaVo IXS HD (Size 1, Size 2) | KaVo North America | MUH Digital Extraoral Source X-Ray System |
| 16 Nov 2017 | K173319 | KaVo NOMAD Pro 2 Handheld X-ray System | Aribex | EHD Extraoral with Timer X-Ray Unit |
| 10 Nov 2016 | K162085 | i-CAT FLX V series / KaVo 3D eXam+ V series | Imaging Sciences International | OAS Dental Computed Tomography X-Ray |
| 23 Mar 2004 | K040691 | INTRA ORAL CAMERA SYSTEM & ACCESSORIES, MODEL WIN-100D | WinUs Technology Co., Ltd. | EIA Operative Dental Unit |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| Dental Imaging Technologies CorporationFDA reg. 3021551875 | Quakertown, PA, United States | Complaint file establishment, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9007915). 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.