510(k) · Cleared
ClearedDiagnodent Perio Tip (Accessory)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kavo America Corporation · NBL Light-Induced Fluorescence Caries Detector
Cleared on Aug 2, 2005 as substantially equivalent to DEN990002 (Kavo America, 2000) and 1 other predicate after a 334-day review. Its family tree reaches back 2 generations to 1998. 28 later devices descend from it.
- Decided
- Aug 2, 2005
- Review
- 334 days
- Class
- Class II
- Product code
- NBL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to DEN980003 (1998). 4 ancestors in all. 28 later devices descend from it, 2 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 deviceK042394 Diagnodent Perio Tip (Accessory)Kavo America Corporation · 2005
- Descendant · cites it directly · 27 of its ownK060080 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
Showing 5 of 28 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 28 · See all- K060080Diagnodent 2190 with Periodontal ProbeKavo Dental Corporation · 2006 · cites it directly27descendants
- 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
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) | K042394 | Diagnodent Perio Tip (Accessory) | Kavo America Corporation | 2005 | — |
| +1 | 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 | — |
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 |
|---|---|---|
| 2006 | 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 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? (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 |
|---|---|---|---|
| * | 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 |
| * | K023367 | Detectar, Model N123-MISummary page 1…ence Caries Detection Device, Product Codes EJB, NBL Common/Usual Name: Periodontal Probe 2. Equivalent legally marketed device: DIAGNOdent® K983658 and DETECTAR, K023367. 3. Indications for Use (intended use): For use as an aid in the detection and localization of subgingival dental calculus.… | 2003 |
What descends from it? (28)
See all 282 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?
- 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, K060080 (Kavo Dental Corporation, 2006) has gone furthest, with 27 descendants of its own.
- 7 other devices also cite its predicate DEN990002.
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?
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/K042394 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042394: Diagnodent Perio Tip (Accessory).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042394
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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