VistaPano S Ceph 2.0 (VistaPano S Ceph); VistaPano S 2.0 (VistaPano S); ProVecta S-Pan Ceph 2.0 (ProVecta S-Pan Ceph); ProVecta S-Pan 2.0 (ProVecta S-Pan) (K240040)
Description
VistaPano S Ceph 2.0 (VistaPano S Ceph); VistaPano S 2.0 (VistaPano S); ProVecta S-Pan Ceph 2.0 (ProVecta S-Pan Ceph); ProVecta S-Pan 2.0 (ProVecta S-Pan) by VATECH Co., Ltd., an FDA 510(k) cleared dental device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K240040
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. VistaPano S Ceph 2.0 (VistaPano S Ceph); VistaPano S 2.0 (VistaPano S); ProVecta S-Pan Ceph 2.0 (ProVecta S-Pan Ceph); ProVecta S-Pan 2.0 (ProVecta S-Pan) (K240040) cites 5 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K213326 | VisionX 3.0 | Durr Dental SE | 2021 |
| K170731 | System, X-Ray, Extra oral Source, Digital, PaX-i Plus, PaX-... | VATECH Co., Ltd. | 2017 |
| K163533 | EzDent-i; E2; ProraView | Ewoosoft Co., Ltd. | 2017 |
| K151123 | Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier Film | Pac-Dent International, Inc. | 2016 |
| K122155 | PCH-2500 DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM PAX-I DIGITA... | VATECH Co., Ltd. | 2012 |
Trace the full predicate network for K240040
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.