510(k) · Cleared
ClearedDiaPlus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DiaDent Group International · KLE Agent, Tooth Bonding, Resin
Cleared on May 26, 2020 as substantially equivalent to K043562 (Vericom Co., Ltd., 2005) after a 266-day review. Its family tree reaches back 2 generations to 1999. 1 later device descends from it.
- Decided
- May 26, 2020
- Review
- 266 days
- Class
- Class II
- Product code
- KLE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K992985 (1999). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK992985 Gluma Comfort BondHeraeus Kulzer, Inc. · 1999
- 1 generation backK043562 BC PlusVericom Co., Ltd. · 2005
- This deviceK192392 DiaPlusDiaDent Group International · 2020
- Descendant · cites it directly · 0 of its ownK210421 Diafil & Diafil CapsuleDiaDent Group International · 2021
Most influential descendants
Showing 1 of 1 · See all- K210421Diafil & Diafil CapsuleDiaDent Group International · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K992985 | Gluma Comfort Bond | Heraeus Kulzer, Inc. | 1999 | — |
| −1 | K043562 | BC Plus | Vericom Co., Ltd. | 2005 | — |
| 0 (this device) | K192392 | DiaPlus | DiaDent Group International | 2020 | — |
| +1 | K210421 | Diafil & Diafil Capsule | DiaDent Group International | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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 KLE? 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 KLE device
- #1 K262252 MPa Max adhesivescore 15.1 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K043562 | BC PlusSummary page 4…KLE 510(k) Number K192392 Device Class: II Device Name: DIAPLUS 3 Predicate Devices 510(k) Number: K043562 (Primary Predicate) Applicant: VERICOM Co., Ltd. Device Name: BC Plus Regulation Number:… | 2005 |
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 |
|---|---|---|---|
| K210421 | Diafil & Diafil Capsule | 2021 | 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 21 years and passes through 3 companies; a new generation was cleared every 15.4 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K210421 (DiaDent Group International, 2021) has gone furthest, with 0 descendants of its own.
How does its category compare?
All KLE devicesKLE Agent, Tooth Bonding, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · KLE
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KLE
149in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KLE
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KLE
3in 2025
MAUDE reports naming product code KLE, 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 | 14 | 71 | 2 | 18 |
| 2008 | 3 | 66 | 0 | 9 |
| 2009 | 7 | 79 | 1 | 11 |
| 2010 | 8 | 93 | 1 | 13 |
| 2011 | 10 | 100 | 0 | 69 |
| 2012 | 5 | 66 | 0 | 176 |
| 2013 | 11 | 115 | 0 | 248 |
| 2014 | 6 | 120 | 0 | 260 |
| 2015 | 10 | 118 | 0 | 100 |
| 2016 | 3 | 148 | 1 | 47 |
| 2017 | 4 | 171 | 1 | 42 |
| 2018 | 8 | 124 | 0 | 31 |
| 2019 | 6 | 143 | 0 | 20 |
| 2020 | 6 | 195 | 0 | 6 |
| 2021 | 4 | 163 | 0 | 6 |
| 2022 | 8 | 98 | 0 | 7 |
| 2023 | 6 | 75 | 0 | 7 |
| 2024 | 7 | 61 | 1 | 12 |
| 2025 | 3 | 149 | 0 | 3 |
| 2026 | 7 | 84 | 0 | — |
What is it indicated for?
As a dentine/enamel total etching bonding system for direct adhesion, it is used in the adhesion of all direct restoration
substances.
- Bonding of direct composite
- Bonding to composite and set amalgam
- Bonding of indirect restoration-Porcelain, Composite (Inlays, Onlays, Veneers, Crowns)
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K192392 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192392: DiaPlus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192392
Report an extraction error
Are you the manufacturer?
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