510(k) · Cleared
ClearedDetectar, Model N123-MI
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neks Technologies · EJB Handle, Instrument, Dental
Cleared on Jun 25, 2003 as substantially equivalent to DEN980003 (Diamond General Development Corp., 1998) and 2 other predicates after a 260-day review. Its family tree reaches back 1 generation to 1998. 31 later devices descend from it.
- Decided
- Jun 25, 2003
- Review
- 260 days
- Class
- Class I
- Product code
- EJB
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 1 generation to DEN980003 (1998). 3 ancestors in all. 31 later devices descend from it, 3 citing it directly.
- Root · 1 generation backDEN980003 Diamond Probe/Perio 2000 SystemDiamond General Development Corp. · 1998
- This deviceK023367 Detectar, Model N123-MINeks Technologies · 2003
- Descendant · cites it directly · 28 of its ownK042394 Diagnodent Perio Tip (Accessory)Kavo America Corporation · 2005
- Descendant · 2 generations on · 27 of its ownK060080 Diagnodent 2190 with Periodontal ProbeKavo Dental Corporation · 2006
- Descendant · 2 generations on · 26 of its ownK073074 Key Laser Iii 1243 US with DetectKavo America · 2008
- Descendant · 3 generations on · 25 of its ownK101658 Waterlase MD Turbo Plus Model 7200XXXBiolase Technology, Inc. · 2010 · Recalled
- Descendant · 4 generations on · 21 of its ownK161669 Waterlase ExpressBiolase, Inc. · 2016
Showing 5 of 31 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 31 · See all- K042394Diagnodent Perio Tip (Accessory)Kavo America Corporation · 2005 · cites it directly28descendants
- K060080Diagnodent 2190 with Periodontal ProbeKavo Dental Corporation · 2006 · 2 generations on27descendants
- K073074Key Laser Iii 1243 US with DetectKavo America · 2008 · 2 generations on26descendants
- K101658Waterlase MD Turbo Plus Model 7200XXXBiolase Technology, Inc. · 2010 · 3 generations on25descendants
- K161669Waterlase ExpressBiolase, Inc. · 2016 · 4 generations on21descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN980003 | Diamond Probe/Perio 2000 System | Diamond General Development Corp. | 1998 | — |
| 0 (this device) | K023367 | Detectar, Model N123-MI | Neks Technologies | 2003 | — |
| +1 | K042394 | Diagnodent Perio Tip (Accessory) | Kavo America Corporation | 2005 | — |
| +2 | K060080 | Diagnodent 2190 with Periodontal Probe | Kavo Dental Corporation | 2006 | — |
| +2 | K073074 | Key Laser Iii 1243 US with Detect | Kavo America | 2008 | — |
| +3 | K101658 | Waterlase MD Turbo Plus Model 7200XXX | Biolase Technology, Inc. | 2010 | 1 |
| +4 | K161669 | Waterlase Express | Biolase, Inc. | 2016 | — |
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 |
|---|---|---|
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 3 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 0 |
| 2025 | 4 | 0 |
| 2026 | 4 | 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 EJB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (6)
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 |
|---|---|---|---|
| * | DEN980003 | Diamond Probe/Perio 2000 System Our reading of the summary gave K980749, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN980003, Diamond Probe/Perio 2000 System (Diamond General Development Corp.), granted Jul 17, 1998; older De Novo requests were first filed under a 510(k) number, so this links to the grant. | 1998 |
| Kept off the family tree | K973490 | FDA’s K973490 is Sunglasses Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 1997 |
| * | K982480 | Perioview Model DV-1 Fiberscope and Window Sheath.Summary page 1…mmary Prepared: June 16,2003 4. Device Name: DETECTAR 5. Predicate Devices: Probe@Perio 2000 System (K980749) DentalView@PerioView@System (K97349wK982480) DIAGNOdent Laser Fluorescence Caries Detection Device (K983658)… | 1998 |
| * | 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…ser Fluorescence Caries Detection Device (K983658) Alpha 4 LS Automated Microtiterplate Processor (K973638) Manual periodontal probes [510(k) exempt] 6. Device Description and Intended Use: DETECTAR is indic… | 1997 |
| * | — | Manual periodontal probes Named without a submission number |
What descends from it? (31)
See all 313 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?
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K042394 (Kavo America Corporation, 2005) has gone furthest, with 28 descendants of its own.
How does its category compare?
All EJB devicesEJB Handle, Instrument, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EJB
1in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · EJB
Too few EJB 510(k)s in any year since 2007 to give a median.
Recalls per year · EJB
1in 2008
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EJB
1in 2021
MAUDE reports naming product code EJB, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 1 | 0 |
| 2009 | 0 | — | 0 | 2 |
| 2010 | 0 | — | 0 | 18 |
| 2011 | 0 | — | 0 | 6 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 1 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
DETECTAR is indicated for the detection of subgingival dental calculus
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023367 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023367: Detectar, Model N123-MI.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023367
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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