Dental Imaging Technologies Corporation
Quakertown, PA, US
Dental Imaging Technologies Corporation appears in FDA device records in Quakertown, PA. FDA records list 12 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 6 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
2 namesFDA records resolved to Dental Imaging Technologies Corporation carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Imaging Sciences International, LLC510(k), enforcement report, recall
- Imaging Sciences Intl., Inc.510(k), recall
510(k) clearance history
FDA records hold 12 510(k) clearances for Dental Imaging Technologies Corporation between 1993 and 2026. The busiest year on record is 2014, with 2. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1993 | 1 |
| 1998 | 1 |
| 1999 | 1 |
| 2000 | 1 |
| 2004 | 1 |
| 2005 | 1 |
| 2006 | 1 |
| 2014 | 2 |
| 2016 | 1 |
| 2023 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K253864 | NOMAD Pro 3 | EHD | Substantially Equivalent | |
| K233053 | DEXIS Ti2 Intraoral Sensor, DEXIS IXS Size 1 Intraoral Sensor, DEXIS IXS Size 2 Intraoral Sensor | MUH | Substantially Equivalent | |
| K162085 | i-CAT FLX V series / KaVo 3D eXam+ V series | OAS | Substantially Equivalent | |
| K133620 | CONE BEAM 3D AND 2D PANORAMIC DENTAL IMAGING SYSTEM | OAS | Substantially Equivalent | |
| K140445 | DEXIS SOFTWARE: DEXIS IMAGING SUITE, DEXIS MAC | LLZ | Substantially Equivalent | |
| K061284 | I-CAT SCANNER | MUH | Substantially Equivalent | |
| K051980 | DVT SCANNER | JAK | Substantially Equivalent | |
| K041078 | SURGPLAN AND PANPLAN | LLZ | Substantially Equivalent | |
| K001248 | MULTI-PULSE 2000 | EHD | Substantially Equivalent | |
| K991518 | PANATOME | EHD | Substantially Equivalent | |
| K981466 | XR-910 | IZL | Substantially Equivalent | |
| K931815 | 2000 X-RAY - TOMOGRAPHIC | IZF | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3021551875 | 3021551875 | Dental Imaging Technologies Corporation | 450 Commerce Drive, Quakertown, PA 18951 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- EHAAligner, Beam, X-Ray
- EGZHolder, Film, X-Ray
- IWYHolder, Head, Radiographic
- PNNOrthodontic Software
- LLZSystem, Image Processing, Radiological
- NOFSystem, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations
- MUHSystem, X-Ray, Extraoral Source, Digital
- IZLSystem, X-Ray, Mobile
- IZFSystem, X-Ray, Tomographic
- JAKSystem, X-Ray, Tomography, Computed
- EIAUnit, Operative Dental
- EHDUnit, X-Ray, Extraoral With Timer
- OASX-Ray, Tomography, Computed, Dental
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2463-2012 | DEXIS Imaging Suite - catalog number 1.008.7932, 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 several conditions need to be met: 1) | Class II | Terminated | |
| Z-3018-2011 | 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 or other physician needs 3D information of high contrast objects. | Recalling firm received a customer complaint regarding a defective X-ray tube head and power supply | Terminated | ||
| Z-0543-2010 | 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 | Terminated | ||
| Z-1265-2009 | 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 | Terminated | ||
| Z-1646-2008 | i-CAT 17-19 Cone Beam 3D Dental Imaging System. This product is also sold under a private label as KaVo 3D eXam | Incorrect scatter information in the manual. | Terminated | ||
| Z-1645-2008 | i-CAT Classic 3D Dental Imaging System | incorrect scatter labeling | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain