510(k) · Cleared
Recalled · 2006Optibond Solo Plus 2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sybron Dental Specialties, Inc. · KLE Agent, Tooth Bonding, Resin
Cleared on Jul 9, 1999 after a 43-day review. The FDA summary names its predicate without a number. 1 later device descends from it. It has been recalled 9 times.
- Decided
- Jul 9, 1999
- Review
- 43 days
- Class
- Class II
- Product code
- KLE
- Recalls
- 9
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK991808 Optibond Solo Plus 2Sybron Dental Specialties, Inc. · 1999
- Descendant · cites it directly · 0 of its ownK111431 B1P AdhesivePentron Clinical · 2011
Most influential descendants
Showing 1 of 1 · See all- K111431B1P AdhesivePentron Clinical · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K991808 | Optibond Solo Plus 2 | Sybron Dental Specialties, Inc. | 1999 | — |
| +1 | K111431 | B1P Adhesive | Pentron Clinical | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 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 |
|---|---|---|---|
| * | — | OptiBond Solo Plus Named without a submission number |
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 |
|---|---|---|---|
| K111431 | B1P Adhesive | 2011 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 29, 2006 | Not classified | Z-1521-06 | Other | Mis-pack/mis-label: The OptiBond Self Etch Primer and OptiBond Solo Plus Adhesive in the chambers were mis-packaged/mis-labeled in reverse order. Application of these products in reverse order may result in compromised bond strength. |
| Mar 3, 2006 | Not classified | Z-0686-06 | Other | The affected lot of product may not activate properly throughout the full intended shelf life and may result in lower than expected bonding performance. |
| Mar 3, 2006 | Not classified | Z-0691-06 | Other | The affected lot of product may not activate properly throughout the full intended shelf life and may result in lower than expected bonding performance. |
| Mar 3, 2006 | Not classified | Z-0690-06 | Other | The affected lot of product may not activate properly throughout the full intended shelf life and may result in lower than expected bonding performance. |
| Mar 3, 2006 | Not classified | Z-0687-06 | Other | The affected lot of product may not activate properly throughout the full intended shelf life and may result in lower than expected bonding performance. |
| Mar 3, 2006 | Not classified | Z-0688-06 | Other | The affected lot of product may not activate properly throughout the full intended shelf life and may result in lower than expected bonding performance. |
| Mar 3, 2006 | Not classified | Z-0689-06 | Other | The affected lot of product may not activate properly throughout the full intended shelf life and may result in lower than expected bonding performance. |
| Mar 3, 2006 | Not classified | Z-0692-06 | Other | The affected lot of product may not activate properly throughout the full intended shelf life and may result in lower than expected bonding performance. |
| Mar 3, 2006 | Not classified | Z-0693-06 | Other | The affected lot of product may not activate properly throughout the full intended shelf life and may result in lower than expected bonding performance. |
The 5 latest of 9 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K111431 (Pentron Clinical, 2011) 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.
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?
OptiBond Solo Plus 2 is a multi-purpose bonding agent designed to be used in direct situations, i.e., composite to enamel and/or dentin, composite repair, porcelain repair, composite to metal, amalgam sealing, bonding composite core build-up materials, and indirect situations, i.e., veneers, onlays, inlays, crowns, (used in conjunction with a resin luting agent) post cementation.
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/K991808 · printed Nov 5, 2026
Cite this page
510(k) Report. “K991808: Optibond Solo Plus 2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K991808
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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