510(k) · Cleared
Clearede-1 etchants
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
E Dental Products · KLE Agent, Tooth Bonding, Resin
Cleared on Nov 20, 2015 as substantially equivalent to K031915 (Pulpdent Corporation, 2003) after a 114-day review. Its family tree reaches back 1 generation to 2003. 4 later devices descend from it.
- Decided
- Nov 20, 2015
- Review
- 114 days
- Class
- Class II
- Product code
- KLE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K031915 (2003). 4 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK031915 Pulpdent Etch-Rite RoyalePulpdent Corporation · 2003
- This deviceK152110 e-1 etchantsE Dental Products · 2015
- Descendant · cites it directly · 3 of its ownK172953 Acid EtchantAmerican Orthodontics · 2018
- Descendant · 2 generations on · 1 of its ownK192273 DIAETCH Economic Package Type A, DIATECH Regular Package, DIAETCH…DiaDent Group International · 2020
- Descendant · 2 generations on · 0 of its ownK214054 TP Orthodontics Light-Cure Adhesive System, TP Orthodontics…Tp Orthodontics, Inc. · 2022
- Descendant · 3 generations on · 0 of its ownK210421 Diafil & Diafil CapsuleDiaDent Group International · 2021
Most influential descendants
Showing 4 of 4 · See all- K172953Acid EtchantAmerican Orthodontics · 2018 · cites it directly3descendants
- K192273DIAETCH Economic Package Type A, DIATECH Regular Package, DIAETCH Refill Package Type A…DiaDent Group International · 2020 · 2 generations on1descendant
- K214054TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP…Tp Orthodontics, Inc. · 2022 · 2 generations on0descendants
- K210421Diafil & Diafil CapsuleDiaDent Group International · 2021 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K031915 | Pulpdent Etch-Rite Royale | Pulpdent Corporation | 2003 | — |
| 0 (this device) | K152110 | e-1 etchants | E Dental Products | 2015 | — |
| +1 | K172953 | Acid Etchant | American Orthodontics | 2018 | — |
| +2 | K192273 | DIAETCH Economic Package Type A, DIATECH Regular Package, DIAETCH Refill… | DiaDent Group International | 2020 | — |
| +2 | K214054 | TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied… | Tp Orthodontics, Inc. | 2022 | — |
| +3 | K210421 | Diafil & Diafil Capsule | DiaDent Group International | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 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 |
|---|---|---|---|
| * | K031915 | Pulpdent Etch-Rite RoyaleSummary page 4…sin tooth bonding agent 21 CFR 872.3200 Product code KLE Common Name — phosphoric acid gel etch 7c. Predicate Device: Trade name - Pulpdent Etch-Royale 510(k) Number - K031915 Classification: Resin tooth bonding agent Product code: KLE 21 CFR 872.3200 Common name — phosphoric acid gel etch 7.1 === Pag… | 2003 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K172953 | Acid Etchant | 2018 | 3 |
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. 2015, 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?
Etch enamel, dentin, and glass ionomer cements
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/K152110 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152110: e-1 etchants.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152110
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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