510(k) · Cleared
ClearedVivid, Models 40-A0001, 40-A0004, 40-A0006
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Progeny, Inc. · EIA Unit, Operative Dental
Cleared on May 1, 2009 as substantially equivalent to K032904 (Dentsply Intl., 2003) and 1 other predicate after a 109-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- May 1, 2009
- Review
- 109 days
- Class
- Class I
- Product code
- EIA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K963778 (1996). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK963778 CDR-CamSchick Technologies, Inc. · 1996
- This deviceK090079 Vivid, Models 40-A0001, 40-A0004, 40-A0006Progeny, Inc. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K963778 | CDR-Cam | Schick Technologies, Inc. | 1996 | — |
| 0 (this device) | K090079 | Vivid, Models 40-A0001, 40-A0004, 40-A0006 | Progeny, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 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 EIA? 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 EIA device
- #1 K231845 Dental unit Model: Marescore 14.4 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K032904 | Acucam Concept IV FWT, Model 110-0185G1Summary page 2…of this summary. There are several major independent manufacturers of Intraoral Video Camera Systems on the U.S. market. One is the Gendex EZ CAM. The 510(k) number is K032904. The :,assification of this device is listed as product code EIA. The other currently marketed device is the SCHICK USB (.1M, ma… | 2003 |
| * | K963778 | CDR-CamSummary page 2…f this device is listed as product code EIA. The other currently marketed device is the SCHICK USB (.1M, manufactured by Schick Technologies,. Inc. the 510(k) number is K963778. The classification of this device5 is listed as product code EIA. Labeling for the currently marketed devices is included as Ap… | 1996 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- None of the 2 ancestors has a recall.
How does its category compare?
All EIA devicesEIA Unit, Operative Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · EIA
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EIA
178in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EIA
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EIA
47in 2025
MAUDE reports naming product code EIA, 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 | 3 | 90 | 0 | 0 |
| 2008 | 6 | 72 | 0 | 0 |
| 2009 | 3 | 109 | 0 | 0 |
| 2010 | 3 | 270 | 0 | 2 |
| 2011 | 5 | 150 | 0 | 3 |
| 2012 | 2 | — | 1 | 7 |
| 2013 | 2 | — | 1 | 6 |
| 2014 | 2 | — | 0 | 255 |
| 2015 | 7 | 214 | 0 | 452 |
| 2016 | 4 | 182 | 0 | 151 |
| 2017 | 1 | — | 0 | 64 |
| 2018 | 2 | — | 0 | 73 |
| 2019 | 2 | — | 0 | 68 |
| 2020 | 1 | — | 0 | 48 |
| 2021 | 0 | — | 0 | 49 |
| 2022 | 3 | 265 | 0 | 44 |
| 2023 | 3 | 686 | 0 | 53 |
| 2024 | 3 | 251 | 0 | 53 |
| 2025 | 7 | 178 | 0 | 47 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Vivid Intraoral Video Camera is intended to provide a dentist with the ability to view the oral cavity prior to and subsequent to dental procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090079 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090079: Vivid, Models 40-A0001, 40-A0004, 40-A0006.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090079
Report an extraction error
Are you the manufacturer?
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