510(k) · Cleared
Recalled · 2010Dentin Conditioning and Adhesive (Bond 1)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jeneric/Pentron, Inc. · KLE Agent, Tooth Bonding, Resin
Cleared on Sep 12, 1997 after a 3-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 6 later devices descend from it. It has been recalled 2 times.
- Decided
- Sep 12, 1997
- Review
- 3 days
- Class
- Class II
- Product code
- KLE
- Recalls
- 2
- Predicates
- 0
6 later devices descend from it, 4 citing it directly.
- This deviceK973388 Dentin Conditioning and Adhesive (Bond 1)Jeneric/Pentron, Inc. · 1997
- Descendant · cites it directly · 2 of its ownK994359 Bond 1 C & BJeneric/Pentron, Inc. · 2000
- Descendant · 2 generations on · 1 of its ownK013543 Bond-1 C & BJeneric/Pentron, Inc. · 2002
- Descendant · 3 generations on · 0 of its ownK122522 Dentoetch Quickbond Bond ActivatorItena Clinical · 2013
- Descendant · cites it directly · 0 of its ownK111431 B1P AdhesivePentron Clinical · 2011
- Descendant · cites it directly · 0 of its ownK013542 Dentin Conditioning and Adhesive System (Bond-1)Jeneric/Pentron, Inc. · 2002
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K994359Bond 1 C & BJeneric/Pentron, Inc. · 2000 · cites it directly2descendants
- K013543Bond-1 C & BJeneric/Pentron, Inc. · 2002 · 2 generations on1descendant
- K122522Dentoetch Quickbond Bond ActivatorItena Clinical · 2013 · 3 generations on0descendants
- K111431B1P AdhesivePentron Clinical · 2011 · cites it directly0descendants
- K013542Dentin Conditioning and Adhesive System (Bond-1)Jeneric/Pentron, Inc. · 2002 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K973388 | Dentin Conditioning and Adhesive (Bond 1) | Jeneric/Pentron, Inc. | 1997 | — |
| +1 | K994359 | Bond 1 C & B | Jeneric/Pentron, Inc. | 2000 | — |
| +2 | K013543 | Bond-1 C & B | Jeneric/Pentron, Inc. | 2002 | — |
| +3 | K122522 | Dentoetch Quickbond Bond Activator | Itena Clinical | 2013 | — |
| +1 | K111431 | B1P Adhesive | Pentron Clinical | 2011 | — |
| +1 | K013542 | Dentin Conditioning and Adhesive System (Bond-1) | Jeneric/Pentron, Inc. | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 2 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (6)
4 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 27, 2010 | Not classified | Z-1142-2012 | Nonconforming Material/Component | The recall was initiated because Pentron Clinical has confirmed that various lots of Bond-1 Primer/Adhesive have been found to have gelled and therefore becomes unusable. |
| Aug 24, 2009 | Not classified | Z-1150-2010 | Nonconforming Material/Component | Some of the material has been found to be gelled and therefore becomes unusable. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K994359 (Jeneric/Pentron, Inc., 2000) has gone furthest, with 2 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?
Adhesion to Dentin and various polymeric filling materials (Composites) used with other conditioners or combination of conditioners for bonding of composite to metal including amalgam, gold, semi precious, and non-precious alloys, porcelain and glass and luting of same to dentin and Enamel.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K973388 · printed Nov 4, 2026
Cite this page
510(k) Report. “K973388: Dentin Conditioning and Adhesive (Bond 1).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973388
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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