510(k) · Cleared
ClearedProVecta 3D Prime Ceph
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Durr Dental SE · OAS X-Ray, Tomography, Computed, Dental
Cleared on Mar 5, 2020 after a 113-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 3 later devices descend from it.
- Decided
- Mar 5, 2020
- Review
- 113 days
- Class
- Class II
- Product code
- OAS
- Recalls
- None
- Predicates
- 1
3 later devices descend from it, 2 citing it directly.
- This deviceK193139 ProVecta 3D Prime CephDurr Dental SE · 2020
- Descendant · cites it directly · 1 of its ownK200271 rainbow CTDentium Co., Ltd (Ict Branch) · 2021
- Descendant · 2 generations on · 0 of its ownK231181 bright CTDentium Co., Ltd (Ict Branch) · 2023
- Descendant · cites it directly · 0 of its ownK232487 Provecta 3D Prime and Provecta 3D Prime CephDurr Dental SE · 2023
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K193139 | ProVecta 3D Prime Ceph | Durr Dental SE | 2020 | — |
| +1 | K200271 | rainbow CT | Dentium Co., Ltd (Ict Branch) | 2021 | — |
| +2 | K231181 | bright CT | Dentium Co., Ltd (Ict Branch) | 2023 | — |
| +1 | K232487 | Provecta 3D Prime and Provecta 3D Prime Ceph | Durr Dental SE | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2023 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OAS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new OAS device
- #1 K213226 RCT700score 18.0 · 13 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K200271 (Dentium Co., Ltd (Ict Branch), 2021) has gone furthest, with 1 descendant of its own.
How does its category compare?
All OAS devicesOAS X-Ray, Tomography, Computed, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · OAS
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OAS
144in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OAS
3in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OAS
1in 2025
MAUDE reports naming product code OAS, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 1 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 6 | 168 | 0 | 0 |
| 2012 | 7 | 110 | 0 | 0 |
| 2013 | 10 | 155 | 0 | 0 |
| 2014 | 5 | 170 | 0 | 0 |
| 2015 | 5 | 164 | 1 | 0 |
| 2016 | 12 | 154 | 0 | 0 |
| 2017 | 4 | 209 | 0 | 0 |
| 2018 | 11 | 57 | 0 | 0 |
| 2019 | 7 | 55 | 0 | 1 |
| 2020 | 9 | 113 | 0 | 0 |
| 2021 | 11 | 92 | 0 | 0 |
| 2022 | 6 | 105 | 0 | 1 |
| 2023 | 12 | 77 | 0 | 1 |
| 2024 | 4 | 129 | 0 | 2 |
| 2025 | 9 | 144 | 3 | 1 |
| 2026 | 9 | 77 | 0 | — |
What is it indicated for?
ProVecta 3D Prime Ceph is a computed tomography x-ray unit intended to generate 3D, panoramic and cephalometric X-ray images in dental radiography for adult and pediatric patients. It provides diagnostic details of the maxillofacial areas for a dental treatment. The device is operated and used by physicians, dentists, and x-ray technicians.
Not intended for mammography use.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K193139 · printed Nov 5, 2026
Cite this page
510(k) Report. “K193139: ProVecta 3D Prime Ceph.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K193139
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026