510(k) · Cleared
ClearedBond 1 C & B
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 Mar 21, 2000 as substantially equivalent to K973388 (Jeneric/Pentron, Inc., 1997) after an 85-day review. Its family tree reaches back 1 generation to 1997. 2 later devices descend from it.
- Decided
- Mar 21, 2000
- Review
- 85 days
- Class
- Class II
- Product code
- KLE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K973388 (1997). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK973388 Dentin Conditioning and Adhesive (Bond 1)Jeneric/Pentron, Inc. · 1997 · Recalled
- This deviceK994359 Bond 1 C & BJeneric/Pentron, Inc. · 2000
- Descendant · cites it directly · 1 of its ownK013543 Bond-1 C & BJeneric/Pentron, Inc. · 2002
- Descendant · 2 generations on · 0 of its ownK122522 Dentoetch Quickbond Bond ActivatorItena Clinical · 2013
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K973388 | Dentin Conditioning and Adhesive (Bond 1) | Jeneric/Pentron, Inc. | 1997 | 2 |
| 0 (this device) | K994359 | Bond 1 C & B | Jeneric/Pentron, Inc. | 2000 | — |
| +1 | K013543 | Bond-1 C & B | Jeneric/Pentron, Inc. | 2002 | — |
| +2 | K122522 | Dentoetch Quickbond Bond Activator | Itena Clinical | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2013 | 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 |
|---|---|---|---|
| * | K973388 | Dentin Conditioning and Adhesive (Bond 1)Summary page 1…: 203-265-7397 X619 Contact Fax: 203-265-7662 Contact Person: Annmarie Tenero Date Summary Prepared: March 14, 2000 Bond 1 C&B is substantially equivalent to Bond 1, K973388. Bond 1 C & B is used for adhesion to dentin and bonding of various polymeric filling materials (composites). Also, Bond 1 C & B… | 1997 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K013543 | Bond-1 C & B | 2002 | 1 |
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?
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?
Bond 1 C & B is used for adhesion to dentin and bonding of various polymeric filling materials (composites). Also, Bond 1 C & B is used 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 summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K994359 · printed Nov 4, 2026
Cite this page
510(k) Report. “K994359: Bond 1 C & B.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K994359
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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