510(k) · Cleared
ClearedCS 1600 Intraoral Camera
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carestream Health, Inc. · NBL Light-Induced Fluorescence Caries Detector
Cleared on Mar 2, 2012 as substantially equivalent to K091186 (Carestream Health, Inc., 2009) and 2 other predicates after a 284-day review. Its family tree reaches back 3 generations to 2000.
- Decided
- Mar 2, 2012
- Review
- 284 days
- Class
- Class II
- Product code
- NBL
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to DEN990002 (2000). 7 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | DEN990002 | Kavo Diagnodent | Kavo America | 2000 | — |
| −2 | K040063 | Inspektor Pro | Inspektor Dental Care BV | 2004 | — |
| −1 | K092583 | Soprolife | Sopro | 2010 | — |
| 0 (this device) | K111423 | CS 1600 Intraoral Camera | Carestream Health, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2009 | 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 NBL? 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 NBL device
- #1 K252464 Surgical Microscope (OMS2360, OMS2380)score 12.5 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K091186 | Kodak 1500 Intraoral CameraSummary page 2…distance in either caries detection mode. 7. Substantial Equivalence Thel CS 1600 is substantially equivalent the Kodak 1500 Intraoral Camera (Carestream Health, Inc., K091 186), to the Inspektor Pro (Inspektor Dental Care by, K040063) and to the SoproLife (K(092583, Sopro). * The Kodak 1500, S… | 2009 |
| * | K040063 | Inspektor ProSummary page 2…Equivalence Thel CS 1600 is substantially equivalent the Kodak 1500 Intraoral Camera (Carestream Health, Inc., K091 186), to the Inspektor Pro (Inspektor Dental Care by, K040063) and to the SoproLife (K(092583, Sopro). * The Kodak 1500, SoproLife, and CS 1600 are each intended for use in… | 2004 |
| * | K092583 | SoprolifeSummary page 2…antially equivalent the Kodak 1500 Intraoral Camera (Carestream Health, Inc., K091 186), to the Inspektor Pro (Inspektor Dental Care by, K040063) and to the SoproLife (K(092583, Sopro). * The Kodak 1500, SoproLife, and CS 1600 are each intended for use in dental or dental sub-specia… | 2010 |
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?
- The line of descent spans 12 years and passes through 4 companies; a new generation was cleared every 4.3 years on median.
- None of the 7 ancestors has a recall.
How does its category compare?
All NBL devicesNBL Light-Induced Fluorescence Caries Detector: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · NBL
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NBL
Too few NBL 510(k)s in any year since 2007 to give a median.
Recalls per year · NBL
No recall names NBL since 2007.
Adverse event reports per year · NBL
1in 2020
MAUDE reports naming product code NBL, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 1 | — | 0 | 1 |
| 2017 | 1 | — | 0 | 1 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 2 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The CS 1600 is indicated for use by health professionals as an aid in the detection of dental caries. It is also indicated for use in viewing and capturing intraoral or extraoral color video images for the purpose of:
* Allowing practitioners to view and magnify all regions of the oral cavity
* Assisting in communication with the patient by providing a view of treatment areas before and after a procedure
* Providing images for documentation in patient records.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111423 · printed Nov 4, 2026
Cite this page
510(k) Report. “K111423: CS 1600 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/K111423
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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