510(k) · Cleared
ClearedDiagnodent 2190 with Periodontal Probe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kavo Dental Corporation · NTK Light Transmission Caries Detector
Cleared on Feb 8, 2006 as substantially equivalent to K042394 (Kavo America Corporation, 2005) and 1 other predicate after a 29-day review. Its family tree reaches back 3 generations to 1998. 27 later devices descend from it.
- Decided
- Feb 8, 2006
- Review
- 29 days
- Class
- Class II
- Product code
- NTK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to DEN980003 (1998). 6 ancestors in all. 27 later devices descend from it, 1 citing it directly.
- Root · 3 generations backDEN980003 Diamond Probe/Perio 2000 SystemDiamond General Development Corp. · 1998
- 2 generations backK023367 Detectar, Model N123-MINeks Technologies · 2003
- 1 generation backK042394 Diagnodent Perio Tip (Accessory)Kavo America Corporation · 2005
- This deviceK060080 Diagnodent 2190 with Periodontal ProbeKavo Dental Corporation · 2006
- Descendant · cites it directly · 26 of its ownK073074 Key Laser Iii 1243 US with DetectKavo America · 2008
- Descendant · 2 generations on · 25 of its ownK101658 Waterlase MD Turbo Plus Model 7200XXXBiolase Technology, Inc. · 2010 · Recalled
- Descendant · 3 generations on · 21 of its ownK161669 Waterlase ExpressBiolase, Inc. · 2016
- Descendant · 3 generations on · 19 of its ownK190319 Waterlase Laser System FamilyBiolase, Inc. · 2019
- Descendant · 4 generations on · 11 of its ownK193656 SkyPulseFotona D.O.O. · 2020
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 27 · See all- K073074Key Laser Iii 1243 US with DetectKavo America · 2008 · cites it directly26descendants
- K101658Waterlase MD Turbo Plus Model 7200XXXBiolase Technology, Inc. · 2010 · 2 generations on25descendants
- K161669Waterlase ExpressBiolase, Inc. · 2016 · 3 generations on21descendants
- K190319Waterlase Laser System FamilyBiolase, Inc. · 2019 · 3 generations on19descendants
- K193656SkyPulseFotona D.O.O. · 2020 · 4 generations on11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | DEN980003 | Diamond Probe/Perio 2000 System | Diamond General Development Corp. | 1998 | — |
| −2 | K023367 | Detectar, Model N123-MI | Neks Technologies | 2003 | — |
| −1 | K042394 | Diagnodent Perio Tip (Accessory) | Kavo America Corporation | 2005 | — |
| 0 (this device) | K060080 | Diagnodent 2190 with Periodontal Probe | Kavo Dental Corporation | 2006 | — |
| +1 | K073074 | Key Laser Iii 1243 US with Detect | Kavo America | 2008 | — |
| +2 | K101658 | Waterlase MD Turbo Plus Model 7200XXX | Biolase Technology, Inc. | 2010 | 1 |
| +3 | K161669 | Waterlase Express | Biolase, Inc. | 2016 | — |
| +3 | K190319 | Waterlase Laser System Family | Biolase, Inc. | 2019 | — |
| +4 | K193656 | SkyPulse | Fotona D.O.O. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 NTK? 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 NTK device
- #1 K261847 iTero Lumina™ Proscore 13.4 · 7 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 |
|---|---|---|---|
| * | K042394 | Diagnodent Perio Tip (Accessory)Summary page 1…Caries Detection Device, Product Codes NTK Common/Usual Name: Laser fluorescence caries detection device 2. Equivalent legally marketed device: DIAGNOdent® 2095, K042394 AND Diagnodent Pen, K05 1909. 3. Indications for Use (intended use): For use as an aid in the detection and localization of… | 2005 |
| * | K051909 | DiagnodentSummary page 1…oduct Codes NTK Common/Usual Name: Laser fluorescence caries detection device 2. Equivalent legally marketed device: DIAGNOdent® 2095, K042394 AND Diagnodent Pen, K05 1909. 3. Indications for Use (intended use): For use as an aid in the detection and localization of subgingival dental calculus.… | 2005 |
What descends from it? (27)
See all 271 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K073074 | Key Laser Iii 1243 US with Detect | 2008 | 26 |
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 8 years and passes through 4 companies; a new generation was cleared every 2.1 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K073074 (Kavo America, 2008) has gone furthest, with 26 descendants of its own.
- 1 other device also cites its predicate K042394.
How does its category compare?
All NTK devicesNTK Light Transmission Caries Detector: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NTK
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NTK
Too few NTK 510(k)s in any year since 2007 to give a median.
Recalls per year · NTK
No recall names NTK since 2007.
Adverse event reports per year · NTK
2in 2025
MAUDE reports naming product code NTK, 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 | 2 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 2 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
For use as an aid in the detection and localization of subgingival dental calculus.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060080 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060080: Diagnodent 2190 with Periodontal Probe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060080
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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