Data / Medical devices / United States / Dental Imaging Technologies Corporation
Dental Imaging Technologies Corporation: FDA-registered device maker in Quakertown, PA, United States, 8 510(k) clearances
Dental Imaging Technologies Corporation is registered with the FDA (registration 3021551875) in Quakertown, PA, United States. It lists 10 device types. The FDA files 8 510(k) clearances under its listings, the newest dated March 20, 2026. 5 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3021551875
- Address
- 450 Commerce Drive, Quakertown, PA, United States, 18951
- Owner or operator
- Dental Imaging Technologies Corporation (9007915)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- August 2, 2010
- Registered through
- 2027
- Brand names listed
- Alignment Bars, CS Model+, DEXIS IS 3700, DEXIS IS 3800, DEXIS IS 3800W, DEXIS IXS Size 1, DEXIS IXS Size 1 Intraoral Sensor, DEXIS IXS Size 2 and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 20, 2026 | K253864 | NOMAD Pro 3 | EHD | Substantially Equivalent | Dental Imaging Technologies Corporation | accessdata.fda.gov |
| November 21, 2023 | K233053 | DEXIS Ti2 Intraoral Sensor, DEXIS IXS Size 1 Intraoral Sensor, DEXIS IXS Size 2 Intraoral Sensor | MUH | Substantially Equivalent | Dental Imaging Technologies Corporation | accessdata.fda.gov |
| April 2, 2020 | K193390 | CS Model+ | PNN | Substantially Equivalent | Trophy | accessdata.fda.gov |
| December 18, 2017 | K172918 | DEXIS Titanium, KaVo IXS HD (Size 1, Size 2) | MUH | Substantially Equivalent | Kavo Dental Technologies, LLC | accessdata.fda.gov |
| November 16, 2017 | K173319 | KaVo NOMAD Pro 2 Handheld X-ray System | EHD | Substantially Equivalent | Aribex | accessdata.fda.gov |
| November 10, 2016 | K162085 | i-CAT FLX V series / KaVo 3D eXam+ V series | OAS | Substantially Equivalent | Imaging Sciences International | accessdata.fda.gov |
| June 22, 2009 | K090431 | DEXIS SOFTWARE | LLZ | Substantially Equivalent | Dexis, LLC | accessdata.fda.gov |
| March 23, 2004 | K040691 | INTRA ORAL CAMERA SYSTEM & ACCESSORIES, MODEL WIN-100D | EIA | Substantially Equivalent | Win-Us Technology Co., Ltd. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| July 30, 2012 | 62830 | Class II | Terminated | DEXIS Imaging Suite - catalog number, version numbers 10.0.0 through 10.0.3 Radiological Image Processing System | A condition can occur during renumbering of the patient database using the DEXCopy feature. When renumbering is being performed using the DEXCopy feature and multiple patients with an identical name are present, the software will assign all subsequent records to the first patient record, resulting in mixed patient records. In order for this problem to occur | accessdata.fda.gov |
| December 15, 2010 | 57583 | Not yet classified | Terminated | i-CAT Classic (X-Ray Tube head and Power Supply) X-Ray imaging device that constructs a three dimensional model from images taken during a rotational X-Ray sequence. Intended to be used whenever a dentist, oral surgeon o | Recalling firm received a customer complaint regarding a defective X-ray tube head and power supply | accessdata.fda.gov |
| October 30, 2009 | 53771 | Not yet classified | Terminated | i-Cat Classic, 3D Dental Imaging System manufactured by Imaging Sciences International, Hatfield, PA. To be used whenever a dentis, oral surgeon or other physician needs 3D information of high contrast objects. | overhead carriage drops quickly | accessdata.fda.gov |
| January 8, 2009 | 51424 | Not yet classified | Terminated | Gendex CB-500, 3D Dental Imaging Systems, Model Number G1-15-1-0. This product is manufactured by Imaging Sciences International for Gendex Corporation. | faulty calibration | accessdata.fda.gov |
| March 19, 2008 | 47535 | Not yet classified | Terminated | i-CAT Classic 3D Dental Imaging System | incorrect scatter labeling | accessdata.fda.gov |
Compare with other makers
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- All makers of Unit, Operative Dental
Updated March 20, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.