510(k) · Cleared
ClearedK-Etchant Gel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kuraray Medical, Inc. · EBF Material, Tooth Shade, Resin
Cleared on Nov 8, 2006 as substantially equivalent to K943165 (Kuraray Company, Ltd., 1994) and 2 other predicates after an 83-day review. Its family tree reaches back 2 generations to 1994. 6 later devices descend from it.
- Decided
- Nov 8, 2006
- Review
- 83 days
- Class
- Class II
- Product code
- EBF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K943165 (1994). 3 ancestors in all. 6 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK943165 Clearfil Photo BondKuraray Company, Ltd. · 1994
- 1 generation backK012432 Modification to Clearfil Photo BondKuraray Medical, Inc. · 2001
- This deviceK062409 K-Etchant GelKuraray Medical, Inc. · 2006
- Descendant · cites it directly · 1 of its ownK242675 FineEtch (FineEtch-10 1.2ml, FineEtch-10 5ml, FineEtch-37 1.2ml…Spident Co., Ltd. · 2024
- Descendant · cites it directly · 1 of its ownK080305 Nexcomp and Meta EtchantMeta Biomed Co., Ltd. · 2008
- Descendant · 2 generations on · 0 of its ownK260485 Any-EtchMediclus Co., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK181689 NexcompMeta Biomed Co., Ltd. · 2018
- Descendant · cites it directly · 0 of its ownK133078 K-Etchant Syringe; Needle Tip (E)Kuraray Noritake Dental, Inc. · 2013
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K242675FineEtch (FineEtch-10 1.2ml, FineEtch-10 5ml, FineEtch-37 1.2ml FineEtch-37 5ml…Spident Co., Ltd. · 2024 · cites it directly1descendant
- K080305Nexcomp and Meta EtchantMeta Biomed Co., Ltd. · 2008 · cites it directly1descendant
- K260485Any-EtchMediclus Co., Ltd. · 2026 · 2 generations on0descendants
- K181689NexcompMeta Biomed Co., Ltd. · 2018 · 2 generations on0descendants
- K133078K-Etchant Syringe; Needle Tip (E)Kuraray Noritake Dental, Inc. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K943165 | Clearfil Photo Bond | Kuraray Company, Ltd. | 1994 | — |
| −1 | K012432 | Modification to Clearfil Photo Bond | Kuraray Medical, Inc. | 2001 | — |
| 0 (this device) | K062409 | K-Etchant Gel | Kuraray Medical, Inc. | 2006 | — |
| +1 | K242675 | FineEtch (FineEtch-10 1.2ml, FineEtch-10 5ml, FineEtch-37 1.2ml FineEtch-37… | Spident Co., Ltd. | 2024 | — |
| +1 | K080305 | Nexcomp and Meta Etchant | Meta Biomed Co., Ltd. | 2008 | — |
| +2 | K260485 | Any-Etch | Mediclus Co., Ltd. | 2026 | — |
| +2 | K181689 | Nexcomp | Meta Biomed Co., Ltd. | 2018 | — |
| +1 | K133078 | K-Etchant Syringe; Needle Tip (E) | Kuraray Noritake Dental, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 0 |
| 2013 | 1 | 0 |
| 2018 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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 EBF? 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 EBF device
- #1 K202846 Tera Harzscore 18.5 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K943165 | Clearfil Photo BondSummary page 1…e of the components in CLEARFIL PHOTO BOND, independently as : single device "K-ETCHANT GEL". l) CLEARFIL PHOTO BOND 514,(k) Number: K943165 K012432 (modification)… | 1994 |
| * | K012432 | Modification to Clearfil Photo BondSummary page 1…-ETCHANT GEL". l) CLEARFIL PHOTO BOND 514,(k) Number: K943165 K012432 (modification) PrT'I:uct Code: KLE… | 2001 |
| * | K031915 | Pulpdent Etch-Rite RoyaleSummary page 1…0 Ap dlicant: KURARAY MEDICAL INC. 2) PULPDENT ETCH-RITE ROYALE 5 I l(k) Number: K031915 PrT:diuct Code: KLE 21… | 2003 |
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)
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 12 years and passes through 2 companies; a new generation was cleared every 7.1 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K242675 (Spident Co., Ltd., 2024) has gone furthest, with 1 descendant of its own.
- 5 other devices also cite its predicate K943165.
How does its category compare?
All EBF devicesEBF Material, Tooth Shade, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EBF
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EBF
43in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EBF
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EBF
1in 2025
MAUDE reports naming product code EBF, 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 | 19 | 49 | 1 | 6 |
| 2008 | 14 | 79 | 42 | 10 |
| 2009 | 20 | 84 | 1 | 8 |
| 2010 | 19 | 75 | 6 | 31 |
| 2011 | 19 | 81 | 7 | 31 |
| 2012 | 11 | 86 | 0 | 62 |
| 2013 | 13 | 153 | 0 | 246 |
| 2014 | 10 | 112 | 0 | 195 |
| 2015 | 17 | 123 | 0 | 119 |
| 2016 | 20 | 205 | 0 | 143 |
| 2017 | 15 | 108 | 4 | 42 |
| 2018 | 15 | 115 | 0 | 8 |
| 2019 | 17 | 159 | 2 | 11 |
| 2020 | 15 | 190 | 1 | 2 |
| 2021 | 13 | 178 | 0 | 2 |
| 2022 | 17 | 63 | 0 | 2 |
| 2023 | 9 | 87 | 0 | 8 |
| 2024 | 18 | 120 | 0 | 5 |
| 2025 | 15 | 43 | 0 | 1 |
| 2026 | 16 | 59 | 2 | — |
What is it indicated for?
Etching the enamel and dentine for adhesive restorations.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062409 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062409: K-Etchant Gel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062409
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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