510(k) · Cleared
ClearedClearfil Esthetic Cement & DC Bond
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 26, 2006 as substantially equivalent to K032455 (Kuraray Medical, Inc., 2003) and 2 other predicates after a 40-day review. Its family tree reaches back 8 generations to 1993. 10 later devices descend from it.
- Decided
- Sep 26, 2006
- Review
- 40 days
- Class
- Class II
- Product code
- EMA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K931812 (1993). 22 ancestors in all, the oldest K871636 (1987). 10 later devices descend from it, 3 citing it directly.
- Root · 8 generations backK931812 New Dentine AdhesiveDentsply Intl. · 1993
- 7 generations backK960823 Prime & Bond 2.0 Multipurpose Dentin/Enamel Bonding AgentDentsply Intl. · 1996
- 6 generations backK962348 Prime & Bond 2.1 Multipurpose Dentin/Enamel Bonding AgentDentsply Intl. · 1996
- 5 generations backK964525 Prime & Bond 2.1 M.P. Dentin/Enamel Bonding Agent W/ActivatorDentsply Intl. · 1997
- 4 generations backK974486 Clearfil Liner Bond 2VKuraray America, Inc. · 1998
- 3 generations backK990040 Clearfil SE BondKuraray Co. · 1999
- 2 generations backK012442 Modification to Clearfil SE BondKuraray Medical, Inc. · 2001
- 1 generation backK032455 Panavia F 2.0Kuraray Medical, Inc. · 2003
- This deviceK062410 Clearfil Esthetic Cement & DC BondKuraray Medical, Inc. · 2006
- Descendant · cites it directly · 9 of its ownK081583 Clearfil SA CementKuraray Medical, Inc. · 2008
- Descendant · cites it directly · 6 of its ownK111982 Clearfil DC Core PlusKuraray America, Inc. · 2011
- Descendant · 2 generations on · 5 of its ownK120379 Panavia SA Cement Automix Value Pack (Universal (A2), White) Panavia…Kuraray Medical, Inc. · 2012
- Descendant · 2 generations on · 4 of its ownK142625 PANAVIA SA Cement Plus Automix; (Universal (A2), White…Kuraray Noritake Dental, Inc. · 2015
- Descendant · cites it directly · 2 of its ownK150704 PANAVIA V5: Standard Kit (Universal (A2)), Standard Kit (Clear)…Kuraray Noritake Dental, Inc. · 2015
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K081583Clearfil SA CementKuraray Medical, Inc. · 2008 · cites it directly9descendants
- K111982Clearfil DC Core PlusKuraray America, Inc. · 2011 · cites it directly6descendants
- K120379Panavia SA Cement Automix Value Pack (Universal (A2), White) Panavia SA Cement Automix…Kuraray Medical, Inc. · 2012 · 2 generations on5descendants
- K142625PANAVIA SA Cement Plus Automix; (Universal (A2), White, Translucent); Value Pack…Kuraray Noritake Dental, Inc. · 2015 · 2 generations on4descendants
- K150704PANAVIA V5: Standard Kit (Universal (A2)), Standard Kit (Clear), Introductory Kit…Kuraray Noritake Dental, Inc. · 2015 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K931812 | New Dentine Adhesive | Dentsply Intl. | 1993 | — |
| −7 | K960823 | Prime & Bond 2.0 Multipurpose Dentin/Enamel Bonding Agent | Dentsply Intl. | 1996 | — |
| −6 | K962348 | Prime & Bond 2.1 Multipurpose Dentin/Enamel Bonding Agent | Dentsply Intl. | 1996 | — |
| −5 | K964525 | Prime & Bond 2.1 M.P. Dentin/Enamel Bonding Agent W/Activator | Dentsply Intl. | 1997 | — |
| −4 | K974486 | Clearfil Liner Bond 2V | Kuraray America, Inc. | 1998 | — |
| −3 | K990040 | Clearfil SE Bond | Kuraray Co. | 1999 | — |
| −2 | K012442 | Modification to Clearfil SE Bond | Kuraray Medical, Inc. | 2001 | — |
| −1 | K032455 | Panavia F 2.0 | Kuraray Medical, Inc. | 2003 | — |
| 0 (this device) | K062410 | Clearfil Esthetic Cement & DC Bond | Kuraray Medical, Inc. | 2006 | — |
| +1 | K081583 | Clearfil SA Cement | Kuraray Medical, Inc. | 2008 | — |
| +1 | K111982 | Clearfil DC Core Plus | Kuraray America, Inc. | 2011 | — |
| +2 | K120379 | Panavia SA Cement Automix Value Pack (Universal (A2), White) Panavia SA Cement… | Kuraray Medical, Inc. | 2012 | — |
| +2 | K142625 | PANAVIA SA Cement Plus Automix; (Universal (A2), White, Translucent); Value… | Kuraray Noritake Dental, Inc. | 2015 | — |
| +1 | K150704 | PANAVIA V5: Standard Kit (Universal (A2)), Standard Kit (Clear), Introductory… | Kuraray Noritake Dental, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 5 | 0 |
| 1995 | 1 | 0 |
| 1998 | 2 | 0 |
| 2001 | 2 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K032455 | Panavia F 2.0Summary page 1…Product code: EMA) 3) Common name Composite resin cement 3-3. Predicate device 1) PANAVIA F 2.0 510(k) Number: K032455 Product Code: EMA 21 CFR Section:… | 2003 |
| * | K012735 | Clearfil DC CementSummary page 1…tion: 872.3275 Applicant: KURARAY MEDICAL INC. 2) CLEARFIL DC CEMENT 510(k) Number: K012735 Product Code: EMA 21 CFR Section:… | 2001 |
| * | K043177 | Cleafil DC Core AutomixSummary page 1…on: 872.3275 Applicant: KURARAY MEDICAL INC. 3) CLEARFIL DC CORE AUTOMIX 510(k) Number: K(043177 Product Code: EBF 21 CFR Section:… | 2004 |
What descends from it? (10)
3 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 13 years and passes through 4 companies; a new generation was cleared every 2.2 years on median.
- None of the 22 ancestors has a recall.
- Of its descendants, K081583 (Kuraray Medical, Inc., 2008) has gone furthest, with 9 descendants of its own.
- 13 other devices also cite its predicate K032455.
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?
1) Cementation of crowns, bridges, inlays and onlays made of porcelain, ceramic,
hybrid ceramics, composite resin or metal
2) Cementation of veneers
3) Cementation of adhesion bridges
4) Cementation of metal cores, resin cores, metal posts or glass-fiber posts
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062410 · printed Nov 5, 2026
Cite this page
510(k) Report. “K062410: Clearfil Esthetic Cement & DC Bond.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K062410
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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