510(k) · Cleared
ClearedEverbond
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Espe Dental AG · KLE Agent, Tooth Bonding, Resin
Cleared on Dec 16, 1998 as substantially equivalent to K962348 (Dentsply Intl., 1996) and 2 other predicates after a 79-day review. Its family tree reaches back 3 generations to 1993.
- Decided
- Dec 16, 1998
- Review
- 79 days
- Class
- Class II
- Product code
- KLE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K931812 (1993). 10 ancestors in all, the oldest K900510 (1990). No later device cites it as a predicate yet.
- Root · 3 generations backK931812 New Dentine AdhesiveDentsply Intl. · 1993
- 2 generations backK960823 Prime & Bond 2.0 Multipurpose Dentin/Enamel Bonding AgentDentsply Intl. · 1996
- 1 generation backK962348 Prime & Bond 2.1 Multipurpose Dentin/Enamel Bonding AgentDentsply Intl. · 1996
- This deviceK983414 EverbondEspe Dental AG · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K931812 | New Dentine Adhesive | Dentsply Intl. | 1993 | — |
| −2 | K960823 | Prime & Bond 2.0 Multipurpose Dentin/Enamel Bonding Agent | Dentsply Intl. | 1996 | — |
| −1 | K962348 | Prime & Bond 2.1 Multipurpose Dentin/Enamel Bonding Agent | Dentsply Intl. | 1996 | — |
| 0 (this device) | K983414 | Everbond | Espe Dental AG | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 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? (3)
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 |
|---|---|---|---|
| * | K962348 | Prime & Bond 2.1 Multipurpose Dentin/Enamel Bonding AgentSummary page 1…l (K810266). Concerning the intended use the priming/bonding agent is substantially equivalent to Dentsply’s Multipurpose Dentin/Enamel Bonding Agent Bond & Prime 2. 1® (K962348). Concerning the ingredients Everbond® is substantially equivalent to the formerly 510(k) cleared ESPE products Pertac® Il (K9624… | 1996 |
| * | K962440 | Pertac II/Pertac II AplitipSummary page 1…mel Bonding Agent Bond & Prime 2. 1® (K962348). Concerning the ingredients Everbond® is substantially equivalent to the formerly 510(k) cleared ESPE products Pertac® Il (K962440), Hytac® (K962442), and Hytac® OSB (K962442). All predicate devices are well-established and determined to be safe, effective an… | 1996 |
| * | K962442 | Hytac Aplitip/Hytac OsbSummary page 1…Bond & Prime 2. 1® (K962348). Concerning the ingredients Everbond® is substantially equivalent to the formerly 510(k) cleared ESPE products Pertac® Il (K962440), Hytac® (K962442), and Hytac® OSB (K962442). All predicate devices are well-established and determined to be safe, effective and beneficial. To… | 1996 |
What descends from it?
No later submission names this one as a predicate yet.
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 5 years and passes through 2 companies; a new generation was cleared every 2.4 years on median.
- None of the 10 ancestors has a recall.
- 3 other devices also cite its predicate K962348.
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?
Bonding of enamel/dentin and composite or compomer restorative materials.
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/K983414 · printed Nov 4, 2026
Cite this page
510(k) Report. “K983414: Everbond.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983414
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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