De Novo · Granted
GrantedDiamond Probe/Perio 2000 System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diamond General Development Corp. · MVH Device, Detection, Sulfide
Granted on Jul 17, 1998 as a new device type through De Novo after a 60-day review. 32 later devices descend from it.
- Decided
- Jul 17, 1998
- Review
- 60 days
- Class
- Class II
- Product code
- MVH
- Recalls
- None
32 later devices descend from it, 1 citing it directly.
- This deviceDEN980003 Diamond Probe/Perio 2000 SystemDiamond General Development Corp. · 1998
- Descendant · cites it directly · 31 of its ownK023367 Detectar, Model N123-MINeks Technologies · 2003
- Descendant · 2 generations on · 28 of its ownK042394 Diagnodent Perio Tip (Accessory)Kavo America Corporation · 2005
- Descendant · 3 generations on · 27 of its ownK060080 Diagnodent 2190 with Periodontal ProbeKavo Dental Corporation · 2006
- Descendant · 3 generations on · 26 of its ownK073074 Key Laser Iii 1243 US with DetectKavo America · 2008
- Descendant · 4 generations on · 25 of its ownK101658 Waterlase MD Turbo Plus Model 7200XXXBiolase Technology, Inc. · 2010 · Recalled
Showing 5 of 32 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 32 · See all- K023367Detectar, Model N123-MINeks Technologies · 2003 · cites it directly31descendants
- K042394Diagnodent Perio Tip (Accessory)Kavo America Corporation · 2005 · 2 generations on28descendants
- K060080Diagnodent 2190 with Periodontal ProbeKavo Dental Corporation · 2006 · 3 generations on27descendants
- K073074Key Laser Iii 1243 US with DetectKavo America · 2008 · 3 generations on26descendants
- K101658Waterlase MD Turbo Plus Model 7200XXXBiolase Technology, Inc. · 2010 · 4 generations on25descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN980003 | Diamond Probe/Perio 2000 System | Diamond General Development Corp. | 1998 | — |
| +1 | K023367 | Detectar, Model N123-MI | Neks Technologies | 2003 | — |
| +2 | K042394 | Diagnodent Perio Tip (Accessory) | Kavo America Corporation | 2005 | — |
| +3 | K060080 | Diagnodent 2190 with Periodontal Probe | Kavo Dental Corporation | 2006 | — |
| +3 | K073074 | Key Laser Iii 1243 US with Detect | Kavo America | 2008 | — |
| +4 | K101658 | Waterlase MD Turbo Plus Model 7200XXX | Biolase Technology, Inc. | 2010 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 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 De Novo database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MVH? 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
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (32)
See all 321 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K023367 | Detectar, Model N123-MI | 2003 | 31 |
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?
- Of its descendants, K023367 (Neks Technologies, 2003) has gone furthest, with 31 descendants of its own.
How does its category compare?
All MVH devicesMVH Device, Detection, Sulfide: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MVH
FDA has decided no MVH device since 2007.
Median 510(k) review, days · MVH
Too few MVH 510(k)s in any year since 2007 to give a median.
Recalls per year · MVH
No recall names MVH since 2007.
Adverse event reports per year · MVH
No MAUDE report names MVH since 2007.
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 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/DEN980003 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN980003: Diamond Probe/Perio 2000 System.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN980003
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026