510(k) · Cleared
ClearedSeity 37% Phosphoric Acid Etchant Gel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mycone Dental Supply Co., Inc. · KLE Agent, Tooth Bonding, Resin
Cleared on Dec 7, 2011 after a 91-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it.
- Decided
- Dec 7, 2011
- Review
- 91 days
- Class
- Class II
- Product code
- KLE
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK112597 Seity 37% Phosphoric Acid Etchant GelMycone Dental Supply Co., Inc. · 2011
- Descendant · cites it directly · 1 of its ownK192273 DIAETCH Economic Package Type A, DIATECH Regular Package, DIAETCH…DiaDent Group International · 2020
- Descendant · 2 generations on · 0 of its ownK210421 Diafil & Diafil CapsuleDiaDent Group International · 2021
- Descendant · cites it directly · 0 of its ownK150696 Jade 37% Phosphoric Acid Etchant GelDharma Research, Inc. · 2015
Most influential descendants
Showing 3 of 3 · See all- K192273DIAETCH Economic Package Type A, DIATECH Regular Package, DIAETCH Refill Package Type A…DiaDent Group International · 2020 · cites it directly1descendant
- K210421Diafil & Diafil CapsuleDiaDent Group International · 2021 · 2 generations on0descendants
- K150696Jade 37% Phosphoric Acid Etchant GelDharma Research, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K112597 | Seity 37% Phosphoric Acid Etchant Gel | Mycone Dental Supply Co., Inc. | 2011 | — |
| +1 | K192273 | DIAETCH Economic Package Type A, DIATECH Regular Package, DIAETCH Refill… | DiaDent Group International | 2020 | — |
| +2 | K210421 | Diafil & Diafil Capsule | DiaDent Group International | 2021 | — |
| +1 | K150696 | Jade 37% Phosphoric Acid Etchant Gel | Dharma Research, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 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? (3)
2 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K192273 (DiaDent Group International, 2020) has gone furthest, with 1 descendant 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. 2011, 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?
A thixotropic 37% phosphoric acid dental etchant gel for etching enameldentin, and glass lonomer cements to produce the necessary micra-retentive surface for successful bonding of restorations.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K112597 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112597: Seity 37% Phosphoric Acid Etchant Gel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112597
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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