510(k) · Cleared
ClearedPanavia F 2.0
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 Nov 7, 2003 as substantially equivalent to K012432 (Kuraray Medical, Inc., 2001) and 1 other predicate after an 88-day review. Its family tree reaches back 7 generations to 1993. 34 later devices descend from it.
- Decided
- Nov 7, 2003
- Review
- 88 days
- Class
- Class II
- Product code
- EMA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K931812 (1993). 18 ancestors in all, the oldest K871636 (1987). 34 later devices descend from it, 14 citing it directly.
- Root · 7 generations backK931812 New Dentine AdhesiveDentsply Intl. · 1993
- 6 generations backK960823 Prime & Bond 2.0 Multipurpose Dentin/Enamel Bonding AgentDentsply Intl. · 1996
- 5 generations backK962348 Prime & Bond 2.1 Multipurpose Dentin/Enamel Bonding AgentDentsply Intl. · 1996
- 4 generations backK964525 Prime & Bond 2.1 M.P. Dentin/Enamel Bonding Agent W/ActivatorDentsply Intl. · 1997
- 3 generations backK974486 Clearfil Liner Bond 2VKuraray America, Inc. · 1998
- 2 generations backK990040 Clearfil SE BondKuraray Co. · 1999
- 1 generation backK012442 Modification to Clearfil SE BondKuraray Medical, Inc. · 2001
- This deviceK032455 Panavia F 2.0Kuraray Medical, Inc. · 2003
- Descendant · cites it directly · 22 of its ownK094007 Unicem3M Espe AG Dental Products · 2010
- Descendant · cites it directly · 19 of its ownK100756 MALTA3M Espe AG Dental Products · 2010
- Descendant · cites it directly · 10 of its ownK062410 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 · 8 of its ownK110508 Suglue-103M Espe AG · 2011
Showing 5 of 34 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 34 · See all- K094007Unicem3M Espe AG Dental Products · 2010 · cites it directly22descendants
- K100756MALTA3M Espe AG Dental Products · 2010 · cites it directly19descendants
- K062410Clearfil Esthetic Cement & DC BondKuraray Medical, Inc. · 2006 · cites it directly10descendants
- K081583Clearfil SA CementKuraray Medical, Inc. · 2008 · cites it directly9descendants
- K110508Suglue-103M Espe AG · 2011 · cites it directly8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K931812 | New Dentine Adhesive | Dentsply Intl. | 1993 | — |
| −6 | K960823 | Prime & Bond 2.0 Multipurpose Dentin/Enamel Bonding Agent | Dentsply Intl. | 1996 | — |
| −5 | K962348 | Prime & Bond 2.1 Multipurpose Dentin/Enamel Bonding Agent | Dentsply Intl. | 1996 | — |
| −4 | K964525 | Prime & Bond 2.1 M.P. Dentin/Enamel Bonding Agent W/Activator | Dentsply Intl. | 1997 | — |
| −3 | K974486 | Clearfil Liner Bond 2V | Kuraray America, Inc. | 1998 | — |
| −2 | K990040 | Clearfil SE Bond | Kuraray Co. | 1999 | — |
| −1 | K012442 | Modification to Clearfil SE Bond | Kuraray Medical, Inc. | 2001 | — |
| 0 (this device) | K032455 | Panavia F 2.0 | Kuraray Medical, Inc. | 2003 | — |
| +1 | K094007 | Unicem | 3M Espe AG Dental Products | 2010 | — |
| +1 | K100756 | MALTA | 3M Espe AG Dental Products | 2010 | — |
| +1 | K062410 | Clearfil Esthetic Cement & DC Bond | Kuraray Medical, Inc. | 2006 | — |
| +1 | K081583 | Clearfil SA Cement | Kuraray Medical, Inc. | 2008 | — |
| +1 | K110508 | Suglue-10 | 3M Espe AG | 2011 | — |
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 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2008 | 1 | 0 |
| 2010 | 3 | 0 |
| 2011 | 4 | 0 |
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2019 | 5 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2023 | 1 | 0 |
| 2025 | 4 | 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 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? (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.
What descends from it? (34)
See all 3414 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K094007 | Unicem | 2010 | 22 |
| K100756 | MALTA | 2010 | 19 |
| K062410 | Clearfil Esthetic Cement & DC Bond | 2006 | 10 |
| K081583 | Clearfil SA Cement | 2008 | 9 |
| K110508 | Suglue-10 | 2011 | 8 |
| K120379 | Panavia SA Cement Automix Value Pack (Universal (A2), White) Panavia SA Cement Automix… | 2012 | 5 |
| K142625 | PANAVIA SA Cement Plus Automix; (Universal (A2), White, Translucent); Value Pack… | 2015 | 4 |
| K111980 | Clearfil Tri-S Bond Plus | 2011 | 4 |
| K150704 | PANAVIA V5: Standard Kit (Universal (A2)), Standard Kit (Clear), Introductory Kit… | 2015 | 2 |
| K100908 | Unicem HM | 2010 | 1 |
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 10 years and passes through 4 companies; a new generation was cleared every 1.0 years on median.
- None of the 18 ancestors has a recall.
- Of its descendants, K094007 (3M Espe AG Dental Products, 2010) has gone furthest, with 22 descendants of its own.
- 4 other devices also cite its predicate K012432.
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?
PANAVIA F 2.0 is indicated for the following applications:
Cementation of metal crowns and bridges, inlays and onlays.
Cementation of porcelain crowns, inlays and onlays and veneers.
Cementation of composite resin crowns, inlays and onlays
Cementation of adhesion bridges
Cementation of endodontic cores and prefabricated posts
Amalgam bonding
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032455 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032455: Panavia F 2.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032455
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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