510(k) · Cleared
ClearedEtch-Rite Supreme
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 Mar 30, 2012 as substantially equivalent to K882576 (Pulpdent Corp. of America, 1988) and 1 other predicate after a 66-day review. Its family tree reaches back 1 generation to 1988.
- Decided
- Mar 30, 2012
- Review
- 66 days
- Class
- Class II
- Product code
- KLE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K882576 (1988). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK882576 Acid Etch GelPulpdent Corp. of America · 1988
- This deviceK120213 Etch-Rite SupremePulpdent Corporation · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K882576 | Acid Etch Gel | Pulpdent Corp. of America | 1988 | — |
| 0 (this device) | K120213 | Etch-Rite Supreme | Pulpdent Corporation | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 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 |
|---|---|---|---|
| * | K882576 | Acid Etch GelSummary page 1…Pulpdent Etch-Rite Supreme Etch-Rite Etch Royale K882576 K031915 Chemical 36% Phosphoric Acid 38% Phosphoric Acid 37% Phosphoric Acid Co… | 1988 |
| * | K031915 | Pulpdent Etch-Rite RoyaleSummary page 1…Etch-Rite Supreme Etch-Rite Etch Royale K882576 K031915 Chemical 36% Phosphoric Acid 38% Phosphoric Acid 37% Phosphoric Acid Composition: Silica g… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- None of the 2 ancestors has a recall.
How does its category compare?
All KLE devicesKLE Agent, Tooth Bonding, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
Pulpdent Etch-Rite Supreme is a 36% phosphoric acid etchant in gel form that is used by the dental pmofessional for etching dentin, enamel or glass lonomers as one step in tooth restoration.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120213 · printed Nov 4, 2026
Cite this page
510(k) Report. “K120213: Etch-Rite Supreme.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120213
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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