510(k) · Cleared
ClearedPanavia F
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 6, 2001 as substantially equivalent to K002322 (Kuraray America, Inc., 2000) after a 37-day review. Its family tree reaches back 1 generation to 2000. 4 later devices descend from it.
- Decided
- Sep 6, 2001
- Review
- 37 days
- Class
- Class II
- Product code
- EMA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K002322 (2000). 4 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK002322 Modification to Panavia FKuraray America, Inc. · 2000
- This deviceK012441 Panavia FKuraray Medical, Inc. · 2001
- Descendant · cites it directly · 3 of its ownK023842 Clearfil SE Bond PlusKuraray Medical, Inc. · 2003
- Descendant · 2 generations on · 0 of its ownK183391 Novidia Universal BondNobio, Ltd. · 2019
- Descendant · 2 generations on · 0 of its ownK122522 Dentoetch Quickbond Bond ActivatorItena Clinical · 2013
- Descendant · 2 generations on · 0 of its ownK070956 SEA2 Self Etch Adhesive3M Espe Dental Products · 2007
Most influential descendants
Showing 4 of 4 · See all- K023842Clearfil SE Bond PlusKuraray Medical, Inc. · 2003 · cites it directly3descendants
- K183391Novidia Universal BondNobio, Ltd. · 2019 · 2 generations on0descendants
- K122522Dentoetch Quickbond Bond ActivatorItena Clinical · 2013 · 2 generations on0descendants
- K070956SEA2 Self Etch Adhesive3M Espe Dental Products · 2007 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K002322 | Modification to Panavia F | Kuraray America, Inc. | 2000 | — |
| 0 (this device) | K012441 | Panavia F | Kuraray Medical, Inc. | 2001 | — |
| +1 | K023842 | Clearfil SE Bond Plus | Kuraray Medical, Inc. | 2003 | — |
| +2 | K183391 | Novidia Universal Bond | Nobio, Ltd. | 2019 | — |
| +2 | K122522 | Dentoetch Quickbond Bond Activator | Itena Clinical | 2013 | — |
| +2 | K070956 | SEA2 Self Etch Adhesive | 3M Espe Dental Products | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2007 | 1 | 0 |
| 2013 | 1 | 0 |
| 2019 | 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 |
|---|---|---|---|
| * | K002322 | Modification to Panavia FSummary page 1…(k) submission is to alter the name and address of manufacturer, and not to intend other changes. The predicate device is as follow. 1. PANAVIA F by Kuraray Co., Litd. (K002322) 4. Description for the premarket notification PANAVIA F is classified into dental cement, CFR 21 Section 872.3275, because it i… | 2000 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K023842 | Clearfil SE Bond Plus | 2003 | 3 |
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, K023842 (Kuraray Medical, Inc., 2003) has gone furthest, with 3 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?
PANAVIA F is indicated for the following applications:
1) Cementation of metal crowns and bridges, inlays and onlays.
2) Cementation of porcelain crowns, inlays, onlays and veneers.
3) Cementation of composite resin crowns, inlays and onlays
4) Cementation of adhesion bridges and splints
5) Cementation of metal cores and prefabrication posts
6) Bonded amalgam restorations
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/K012441 · printed Nov 4, 2026
Cite this page
510(k) Report. “K012441: Panavia F.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012441
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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