510(k) · Cleared
ClearedClearfil DC Cement
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kuraray Medical, Inc. · EMA Cement, Dental
Cleared on Sep 14, 2001 as substantially equivalent to K980232 (Kuraray Company, Ltd., 1998) after a 31-day review. Its family tree reaches back 1 generation to 1998. 11 later devices descend from it.
- Decided
- Sep 14, 2001
- Review
- 31 days
- Class
- Class II
- Product code
- EMA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K980232 (1998). 11 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK980232 Clearfil DC CementKuraray Company, Ltd. · 1998
- This deviceK012735 Clearfil DC CementKuraray Medical, Inc. · 2001
- Descendant · cites it directly · 10 of its ownK062410 Clearfil Esthetic Cement & DC BondKuraray Medical, Inc. · 2006
- Descendant · 2 generations on · 9 of its ownK081583 Clearfil SA CementKuraray Medical, Inc. · 2008
- Descendant · 2 generations on · 6 of its ownK111982 Clearfil DC Core PlusKuraray America, Inc. · 2011
- Descendant · 3 generations on · 5 of its ownK120379 Panavia SA Cement Automix Value Pack (Universal (A2), White) Panavia…Kuraray Medical, Inc. · 2012
- Descendant · 3 generations on · 4 of its ownK142625 PANAVIA SA Cement Plus Automix; (Universal (A2), White…Kuraray Noritake Dental, Inc. · 2015
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K062410Clearfil Esthetic Cement & DC BondKuraray Medical, Inc. · 2006 · cites it directly10descendants
- K081583Clearfil SA CementKuraray Medical, Inc. · 2008 · 2 generations on9descendants
- K111982Clearfil DC Core PlusKuraray America, Inc. · 2011 · 2 generations on6descendants
- K120379Panavia SA Cement Automix Value Pack (Universal (A2), White) Panavia SA Cement Automix…Kuraray Medical, Inc. · 2012 · 3 generations on5descendants
- K142625PANAVIA SA Cement Plus Automix; (Universal (A2), White, Translucent); Value Pack…Kuraray Noritake Dental, Inc. · 2015 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K980232 | Clearfil DC Cement | Kuraray Company, Ltd. | 1998 | — |
| 0 (this device) | K012735 | Clearfil DC Cement | Kuraray Medical, Inc. | 2001 | — |
| +1 | K062410 | Clearfil Esthetic Cement & DC Bond | Kuraray Medical, Inc. | 2006 | — |
| +2 | K081583 | Clearfil SA Cement | Kuraray Medical, Inc. | 2008 | — |
| +2 | K111982 | Clearfil DC Core Plus | Kuraray America, Inc. | 2011 | — |
| +3 | K120379 | Panavia SA Cement Automix Value Pack (Universal (A2), White) Panavia SA Cement… | Kuraray Medical, Inc. | 2012 | — |
| +3 | K142625 | PANAVIA SA Cement Plus Automix; (Universal (A2), White, Translucent); Value… | Kuraray Noritake Dental, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2015 | 3 | 0 |
| 2019 | 2 | 0 |
| 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 EMA? 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 EMA device
- #1 K254109 G-Cem Universalscore 15.0 · 13 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 |
|---|---|---|---|
| * | K980232 | Clearfil DC CementSummary 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 DC CEMENT by Kuraray Co., Ltd. (K980232) 4. Description for the premarket notification CLEARFIL DC CEMENT is a dual-cure composite resin cement and used as a cement to… | 1998 |
What descends from it? (11)
See all 111 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K062410 | Clearfil Esthetic Cement & DC Bond | 2006 | 10 |
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?
- Its one ancestor has no recall.
- Of its descendants, K062410 (Kuraray Medical, Inc., 2006) has gone furthest, with 10 descendants of its own.
How does its category compare?
All EMA devicesEMA Cement, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EMA
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EMA
106in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EMA
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EMA
9in 2025
MAUDE reports naming product code EMA, 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 | 6 | 48 | 0 | 33 |
| 2008 | 13 | 71 | 2 | 50 |
| 2009 | 10 | 86 | 1 | 90 |
| 2010 | 14 | 86 | 1 | 106 |
| 2011 | 8 | 79 | 5 | 224 |
| 2012 | 10 | 128 | 0 | 249 |
| 2013 | 12 | 178 | 0 | 385 |
| 2014 | 4 | 174 | 0 | 207 |
| 2015 | 9 | 134 | 0 | 85 |
| 2016 | 10 | 182 | 0 | 16 |
| 2017 | 3 | 141 | 0 | 13 |
| 2018 | 3 | 237 | 0 | 4 |
| 2019 | 7 | 127 | 0 | 12 |
| 2020 | 8 | 164 | 0 | 5 |
| 2021 | 4 | 184 | 0 | 8 |
| 2022 | 7 | 245 | 0 | 3 |
| 2023 | 2 | — | 1 | 6 |
| 2024 | 3 | 59 | 0 | 5 |
| 2025 | 10 | 106 | 0 | 9 |
| 2026 | 7 | 150 | 0 | — |
What is it indicated for?
CLEARFIL DC CEMENT is indicated for the following applications:
1) Porcelain inlay cementation
2) Composite resin inlay cementation
3) Jacket crown cementation with porcelain or composite resin
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/K012735 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012735: Clearfil DC Cement.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012735
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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