510(k) · Cleared
ClearedClearfil ST Opaquer
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 Sep 10, 2001 as substantially equivalent to K001913 (Kuraray Company, Ltd., 2000) after a 27-day review. Its family tree reaches back 1 generation to 2000. 5 later devices descend from it.
- Decided
- Sep 10, 2001
- Review
- 27 days
- Class
- Class II
- Product code
- EBF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K001913 (2000). 5 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK001913 Clearfil ST OpaquerKuraray Company, Ltd. · 2000
- This deviceK012704 Clearfil ST OpaquerKuraray Medical, Inc. · 2001
- Descendant · cites it directly · 4 of its ownK063595 Clearfil Majesty PosteriorKuraray America, Inc. · 2007
- Descendant · 2 generations on · 1 of its ownK071169 Clearfil Majesty Posterior PLTKuraray Medical, Inc. · 2007
- Descendant · 2 generations on · 0 of its ownK162967 nuance UNIVERSALDen-Mat Holdings, LLC · 2017
- Descendant · 2 generations on · 0 of its ownK100328 Clearfil Majety PosteriorKuraray Medical, Inc. · 2010
- Descendant · 3 generations on · 0 of its ownK092281 Clearfil Majesty Posterior PLTKuraray Medical, Inc. · 2009
Most influential descendants
Showing 5 of 5 · See all- K063595Clearfil Majesty PosteriorKuraray America, Inc. · 2007 · cites it directly4descendants
- K071169Clearfil Majesty Posterior PLTKuraray Medical, Inc. · 2007 · 2 generations on1descendant
- K162967nuance UNIVERSALDen-Mat Holdings, LLC · 2017 · 2 generations on0descendants
- K100328Clearfil Majety PosteriorKuraray Medical, Inc. · 2010 · 2 generations on0descendants
- K092281Clearfil Majesty Posterior PLTKuraray Medical, Inc. · 2009 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K001913 | Clearfil ST Opaquer | Kuraray Company, Ltd. | 2000 | — |
| 0 (this device) | K012704 | Clearfil ST Opaquer | Kuraray Medical, Inc. | 2001 | — |
| +1 | K063595 | Clearfil Majesty Posterior | Kuraray America, Inc. | 2007 | — |
| +2 | K071169 | Clearfil Majesty Posterior PLT | Kuraray Medical, Inc. | 2007 | — |
| +2 | K162967 | nuance UNIVERSAL | Den-Mat Holdings, LLC | 2017 | — |
| +2 | K100328 | Clearfil Majety Posterior | Kuraray Medical, Inc. | 2010 | — |
| +3 | K092281 | Clearfil Majesty Posterior PLT | Kuraray Medical, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2017 | 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? (1)
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 |
|---|---|---|---|
| * | K001913 | Clearfil ST OpaquerSummary page 1…ssion is to alter the name and address of manufacturer, and not to intend other changes. The predicate device is as follow. 1. CLEARFIL ST OPAQUER by Kuraray Co., Ltd. (K001913) 4. Description for the premarket notification CLEARFIL ST OPAQUER is classified into the Tooth Shade Resin Material, CFR 21 Sec… | 2000 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K063595 | Clearfil Majesty Posterior | 2007 | 4 |
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?
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?
CLEARFIL ST OPAQUER is indicated for the following applications:
1) Masking of metal during intraoral repair of porcelain fused-to-metal crowns.
2) Masking of metal in restoration of post and core crowns.
3) Lightening of stained or discolored teeth in porcelain or composite veneer restorations.
4) Masking of pulp capping materials.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K012704 · printed Nov 4, 2026
Cite this page
510(k) Report. “K012704: Clearfil ST Opaquer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012704
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026