510(k) · Cleared
ClearedPanavia SA Cement Handmix Value Pack (Universal (A2), White) Panavia SA Cement Handmix (Universal (A2), White) Panavia S
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 Mar 30, 2012 as substantially equivalent to K081583 (Kuraray Medical, Inc., 2008) and 1 other predicate after a 52-day review. Its family tree reaches back 10 generations to 1993. 1 later device descends from it.
- Decided
- Mar 30, 2012
- Review
- 52 days
- Class
- Class II
- Product code
- EMA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K931812 (1993). 37 ancestors in all, the oldest K871636 (1987). 1 later device descends from it, 1 citing it directly.
- Root · 10 generations backK931812 New Dentine AdhesiveDentsply Intl. · 1993
- 6 generations between
- 3 generations backK032455 Panavia F 2.0Kuraray Medical, Inc. · 2003
- 2 generations backK062410 Clearfil Esthetic Cement & DC BondKuraray Medical, Inc. · 2006
- 1 generation backK081583 Clearfil SA CementKuraray Medical, Inc. · 2008
- This deviceK120378 Panavia SA Cement Handmix Value Pack (Universal (A2), White) Panavia…Kuraray Medical, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK142623 PANAVIA SA Cement Plus HandmixKuraray Noritake Dental, Inc. · 2015
Show all 10 generations
- Root · 10 generations backK931812 New Dentine AdhesiveDentsply Intl. · 1993
- 9 generations backK960823 Prime & Bond 2.0 Multipurpose Dentin/Enamel Bonding AgentDentsply Intl. · 1996
- 8 generations backK962348 Prime & Bond 2.1 Multipurpose Dentin/Enamel Bonding AgentDentsply Intl. · 1996
- 7 generations backK964525 Prime & Bond 2.1 M.P. Dentin/Enamel Bonding Agent W/ActivatorDentsply Intl. · 1997
- 6 generations backK974486 Clearfil Liner Bond 2VKuraray America, Inc. · 1998
- 5 generations backK990040 Clearfil SE BondKuraray Co. · 1999
- 4 generations backK012442 Modification to Clearfil SE BondKuraray Medical, Inc. · 2001
- 3 generations backK032455 Panavia F 2.0Kuraray Medical, Inc. · 2003
- 2 generations backK062410 Clearfil Esthetic Cement & DC BondKuraray Medical, Inc. · 2006
- 1 generation backK081583 Clearfil SA CementKuraray Medical, Inc. · 2008
- This deviceK120378 Panavia SA Cement Handmix Value Pack (Universal (A2), White) Panavia…Kuraray Medical, Inc. · 2012
Most influential descendants
Showing 1 of 1 · See all- K142623PANAVIA SA Cement Plus HandmixKuraray Noritake Dental, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K931812 | New Dentine Adhesive | Dentsply Intl. | 1993 | — |
| −9 | K960823 | Prime & Bond 2.0 Multipurpose Dentin/Enamel Bonding Agent | Dentsply Intl. | 1996 | — |
| −8 | K962348 | Prime & Bond 2.1 Multipurpose Dentin/Enamel Bonding Agent | Dentsply Intl. | 1996 | — |
| −7 | K964525 | Prime & Bond 2.1 M.P. Dentin/Enamel Bonding Agent W/Activator | Dentsply Intl. | 1997 | — |
| −6 | K974486 | Clearfil Liner Bond 2V | Kuraray America, Inc. | 1998 | — |
| −5 | K990040 | Clearfil SE Bond | Kuraray Co. | 1999 | — |
| −4 | K012442 | Modification to Clearfil SE Bond | Kuraray Medical, Inc. | 2001 | — |
| −3 | K032455 | Panavia F 2.0 | Kuraray Medical, Inc. | 2003 | — |
| −2 | K062410 | Clearfil Esthetic Cement & DC Bond | Kuraray Medical, Inc. | 2006 | — |
| −1 | K081583 | Clearfil SA Cement | Kuraray Medical, Inc. | 2008 | — |
| 0 (this device) | K120378 | Panavia SA Cement Handmix Value Pack (Universal (A2), White) Panavia SA Cement… | Kuraray Medical, Inc. | 2012 | — |
| +1 | K142623 | PANAVIA SA Cement Plus Handmix | Kuraray Noritake Dental, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 5 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 3 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2004 | 2 | 0 |
| 2008 | 1 | 0 |
| 2010 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K081583 | Clearfil SA CementSummary page 1…m tCS' C -MCd:CT 3-3. Predicate device 1) CLEARFIL SA CEMENT 5 10(k) Number: K08 1583 Product Code: EMA 21 CFR Section… | 2008 |
| * | K100756 | MALTASummary page 1…872. 3275 Applicant: KURARAY MEDICAL INC. 2) RelyX Unicemn 2 5 10(k) Number: K100756 Product Code: EMA 21 CFR Section… | 2010 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K142623 | PANAVIA SA Cement Plus Handmix | 2015 | 0 |
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 19 years and passes through 4 companies; a new generation was cleared every 2.2 years on median.
- 1 of the 37 ancestors has a recall of any class.
- Of its descendants, K142623 (Kuraray Noritake Dental, Inc., 2015) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K081583.
How does its category compare?
All EMA devicesEMA Cement, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
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?
Cementation of crowns, bridges, inlays and onlays made of porcelain, ceramic, composite resin or metal
Cementation of porcelain, ceramic, composite resin or metal restorations on implant abutments
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/K120378 · printed Nov 4, 2026
Cite this page
510(k) Report. “K120378: Panavia SA Cement Handmix Value Pack (Universal (A2), White) Panavia SA Cement Handmix (Universal (A2), White) Panavia S.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120378
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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