510(k) · Cleared
ClearedKodak 1500 Intraoral Camera
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carestream Health, Inc. · EIA Unit, Operative Dental
Cleared on Aug 18, 2009 as substantially equivalent to K000112 (Dentsply Intl., 2000) and 1 other predicate after a 117-day review. Its family tree reaches back 1 generation to 2000. 1 later device descends from it.
- Decided
- Aug 18, 2009
- Review
- 117 days
- Class
- Class I
- Product code
- EIA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K000112 (2000). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK000112 Acucam Concept IV, Models A1222B, A1223B, A1221B, A1121B, A1222C…Dentsply Intl. · 2000
- This deviceK091186 Kodak 1500 Intraoral CameraCarestream Health, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK111423 CS 1600 Intraoral CameraCarestream Health, Inc. · 2012
Most influential descendants
Showing 1 of 1 · See all- K111423CS 1600 Intraoral CameraCarestream Health, Inc. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K000112 | Acucam Concept IV, Models A1222B, A1223B, A1221B, A1121B, A1222C, A10402… | Dentsply Intl. | 2000 | — |
| 0 (this device) | K091186 | Kodak 1500 Intraoral Camera | Carestream Health, Inc. | 2009 | — |
| +1 | K111423 | CS 1600 Intraoral Camera | Carestream Health, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 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 |
|---|---|---|---|
| * | K000112 | Acucam Concept IV, Models A1222B, A1223B, A1221B, A1121B, A1222C, A10402, A10403, A10401Summary page 2…ght LEDs. 7. Substantial Equivalence The Kodak 1500 IntraoralCamera is substantially equivalent to Gendex AcuCam Concept IV Intraoral Camera System (Gendex, K0001 12) and to the STV Pro 2 (Trophy Radiologie, K033419). * Each device is intended for use in dental or dental s… | 2000 |
| * | K033419 | STV Pro 2Summary page 2…0 IntraoralCamera is substantially equivalent to Gendex AcuCam Concept IV Intraoral Camera System (Gendex, K0001 12) and to the STV Pro 2 (Trophy Radiologie, K033419). * Each device is intended for use in dental or dental sub-specialty intraoral video image acqu… | 2004 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K111423 | CS 1600 Intraoral Camera | 2012 | 0 |
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?
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 Kodak 1500 Intraoral Camera is indicated for use by health professionals in viewing and capturing intraoral or extraoral color video images for the purposes of:
1. Allowing practitioners to view and magnify regions of the oral cavity
2. Assisting communications with the patient by providing a view of treatment areas before and after a procedure
3. Providing images for documentation in patient records.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091186 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091186: Kodak 1500 Intraoral Camera.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091186
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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