510(k) · Cleared
ClearedD-Carie, Model N121-M1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neks Technologies, Inc. · NBL Light-Induced Fluorescence Caries Detector
Cleared on Apr 28, 2005 as substantially equivalent to K023367 (Neks Technologies, 2003) and 1 other predicate after a 164-day review. Its family tree reaches back 2 generations to 1998. 1 later device descends from it.
- Decided
- Apr 28, 2005
- Review
- 164 days
- Class
- Class II
- Product code
- NBL
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to DEN980003 (1998). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backDEN980003 Diamond Probe/Perio 2000 SystemDiamond General Development Corp. · 1998
- 1 generation backK023367 Detectar, Model N123-MINeks Technologies · 2003
- This deviceK043156 D-Carie, Model N121-M1Neks Technologies, Inc. · 2005
- Descendant · cites it directly · 0 of its ownK063321 D-Carie/Detectar, Models N121, N123, N133, N134, N135 & N138Neks Technologies, Inc. · 2007
Most influential descendants
Showing 1 of 1 · See all- K063321D-Carie/Detectar, Models N121, N123, N133, N134, N135 & N138Neks Technologies, Inc. · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | DEN980003 | Diamond Probe/Perio 2000 System | Diamond General Development Corp. | 1998 | — |
| −1 | K023367 | Detectar, Model N123-MI | Neks Technologies | 2003 | — |
| 0 (this device) | K043156 | D-Carie, Model N121-M1 | Neks Technologies, Inc. | 2005 | — |
| +1 | K063321 | D-Carie/Detectar, Models N121, N123, N133, N134, N135 & N138 | Neks Technologies, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 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 12.4 · 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? (4)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K023367 | Detectar, Model N123-MISummary page 1…ax: (450) 973-3881 3. Date Summary Prepared April 19, 2005 4. Device Name: D-CARIE 5. Predicate Devices: Detectar System (K023367) DIAGNOdent Laser Fluorescence Caries Detection Device (K… | 2003 |
| * | DEN990002 | Kavo Diagnodent Our reading of the summary gave K983658, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN990002, Kavo Diagnodent (Kavo America), granted Feb 22, 2000; older De Novo requests were first filed under a 510(k) number, so this links to the grant. | 2000 |
| Kept off the family tree | K973638 | FDA’s K973638 is N.I.T., Inc. Needle Guiding Template Our reading of the summary gave K973638, FDA’s number for N.I.T., Inc. Needle Guiding Template (Avid N.I.T., Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Alpha 4 LS Automated Microtiterplate Processor”. Kept off the family tree. Summary page 1…(K983658) : Alpha 4 LS Automated Microtiterplate Processor (K973638) Dental explorers [510(k) exempt] 6. Device Description and Intended Use: Similar to th… | 1997 |
| * | — | Dental explorers Named without a submission number |
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 |
|---|---|---|---|
| K063321 | D-Carie/Detectar, Models N121, N123, N133, N134, N135 & N138 | 2007 | 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?
- The line of descent spans 7 years and passes through 3 companies; a new generation was cleared every 4.9 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K063321 (Neks Technologies, Inc., 2007) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K023367.
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.
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?
D-Carie is indicated for aiding in the diagnosis of dental carries
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043156 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043156: D-Carie, Model N121-M1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043156
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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