510(k) · Cleared
ClearedPulpdent Etch-Rite Royale
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pulpdent Corporation · KLE Agent, Tooth Bonding, Resin
Cleared on Aug 5, 2003 after a 46-day review. The FDA summary names its predicate without a number. 14 later devices descend from it.
- Decided
- Aug 5, 2003
- Review
- 46 days
- Class
- Class II
- Product code
- KLE
- Recalls
- None
- Predicates
- 0
14 later devices descend from it, 4 citing it directly.
- This deviceK031915 Pulpdent Etch-Rite RoyalePulpdent Corporation · 2003
- Descendant · cites it directly · 6 of its ownK062409 K-Etchant GelKuraray Medical, Inc. · 2006
- Descendant · cites it directly · 4 of its ownK152110 e-1 etchantsE Dental Products · 2015
- Descendant · 2 generations on · 3 of its ownK172953 Acid EtchantAmerican Orthodontics · 2018
- Descendant · 2 generations on · 1 of its ownK242675 FineEtch (FineEtch-10 1.2ml, FineEtch-10 5ml, FineEtch-37 1.2ml…Spident Co., Ltd. · 2024
- Descendant · 3 generations on · 1 of its ownK192273 DIAETCH Economic Package Type A, DIATECH Regular Package, DIAETCH…DiaDent Group International · 2020
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K062409K-Etchant GelKuraray Medical, Inc. · 2006 · cites it directly6descendants
- K152110e-1 etchantsE Dental Products · 2015 · cites it directly4descendants
- K172953Acid EtchantAmerican Orthodontics · 2018 · 2 generations on3descendants
- K242675FineEtch (FineEtch-10 1.2ml, FineEtch-10 5ml, FineEtch-37 1.2ml FineEtch-37 5ml…Spident Co., Ltd. · 2024 · 2 generations on1descendant
- K192273DIAETCH Economic Package Type A, DIATECH Regular Package, DIAETCH Refill Package Type A…DiaDent Group International · 2020 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K031915 | Pulpdent Etch-Rite Royale | Pulpdent Corporation | 2003 | — |
| +1 | K062409 | K-Etchant Gel | Kuraray Medical, Inc. | 2006 | — |
| +1 | K152110 | e-1 etchants | E Dental Products | 2015 | — |
| +2 | K172953 | Acid Etchant | American Orthodontics | 2018 | — |
| +2 | K242675 | FineEtch (FineEtch-10 1.2ml, FineEtch-10 5ml, FineEtch-37 1.2ml FineEtch-37… | Spident Co., Ltd. | 2024 | — |
| +3 | K192273 | DIAETCH Economic Package Type A, DIATECH Regular Package, DIAETCH Refill… | DiaDent Group International | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 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 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 |
|---|---|---|---|
| * | — | Pulpdent Semi-Gel Etchant 35% Phosphoric acid Etchant Named without a submission number | |
| * | — | Pulpdent Etch-Rite 38 % Phosphoric Acid Etching Gel Named without a submission number |
What descends from it? (14)
See all 144 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, K062409 (Kuraray Medical, Inc., 2006) has gone furthest, with 6 descendants 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.
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?
Pulpdent Etch-Rite Royale is a 37% phosphoric acid etchant in gel form that is used by the dental professional for etching dentin or enamel before tooth restoration. Etch-Rite Royale is dark blue for contrast with tooth enamel and easy visualization. Etch-Rite Royale is a soft gel that is easily manipulated and that rinses completely without leaving any residue.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031915 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031915: Pulpdent Etch-Rite Royale.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031915
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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