510(k) · Cleared
ClearedDIAETCH Economic Package Type A, DIATECH Regular Package, DIAETCH Refill Package Type A, DIAETCH Intro Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DiaDent Group International · KLE Agent, Tooth Bonding, Resin
Cleared on Feb 7, 2020 as substantially equivalent to K112597 (Mycone Dental Supply Co., Inc., 2011) and 1 other predicate after a 169-day review. Its family tree reaches back 3 generations to 2003. 1 later device descends from it.
- Decided
- Feb 7, 2020
- Review
- 169 days
- Class
- Class II
- Product code
- KLE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K031915 (2003). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK031915 Pulpdent Etch-Rite RoyalePulpdent Corporation · 2003
- 2 generations backK152110 e-1 etchantsE Dental Products · 2015
- 1 generation backK172953 Acid EtchantAmerican Orthodontics · 2018
- This deviceK192273 DIAETCH Economic Package Type A, DIATECH Regular Package, DIAETCH…DiaDent Group International · 2020
- Descendant · cites it directly · 0 of its ownK210421 Diafil & Diafil CapsuleDiaDent Group International · 2021
Most influential descendants
Showing 1 of 1 · See all- K210421Diafil & Diafil CapsuleDiaDent Group International · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K031915 | Pulpdent Etch-Rite Royale | Pulpdent Corporation | 2003 | — |
| −2 | K152110 | e-1 etchants | E Dental Products | 2015 | — |
| −1 | K172953 | Acid Etchant | American Orthodontics | 2018 | — |
| 0 (this device) | K192273 | DIAETCH Economic Package Type A, DIATECH Regular Package, DIAETCH Refill… | DiaDent Group International | 2020 | — |
| +1 | K210421 | Diafil & Diafil Capsule | DiaDent Group International | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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? (2)
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 |
|---|---|---|---|
| * | K112597 | Seity 37% Phosphoric Acid Etchant GelSummary page 4…ial equivalence is being claimed are: Primary Predicate Device Reference Predicate Device 510(k) Number: K112597 K172953 Applicant: MYCONE DENTAL SUPPLY CO., INC. American Orthodontics Devic… | 2011 |
| * | K172953 | Acid EtchantSummary page 4…Primary Predicate Device Reference Predicate Device 510(k) Number: K112597 K172953 Applicant: MYCONE DENTAL SUPPLY CO., INC. American Orthodontics Device Name: seity 37% Phosphoric Aci… | 2018 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K210421 | Diafil & Diafil Capsule | 2021 | 0 |
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 17 years and passes through 4 companies; a new generation was cleared every 2.2 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K210421 (DiaDent Group International, 2021) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K112597.
How does its category compare?
All KLE devicesKLE Agent, Tooth Bonding, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
DiaEtch is a 37% phosphoric acid etchant used for etching enamel and dentin to promote adhesion of primer/bonding agent adhesives to tooth structure and restorative materials.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192273 · printed Nov 5, 2026
Cite this page
510(k) Report. “K192273: DIAETCH Economic Package Type A, DIATECH Regular Package, DIAETCH Refill Package Type A, DIAETCH Intro Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K192273
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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