510(k) · Cleared
ClearedPANAVIA V5: Standard Kit (Universal (A2)), Standard Kit (Clear), Introductory Kit (Universal (A2)), Introductory Kit (Clear), Sample Pack (Universal (A2)), Paste (Universal (A2)), Paste (Clear), Paste (Brown (A4)), Paste (White), Paste (Opaque), Try-in Paste (Universal (A2)), Try-in Paste (Clear), Try-in Paste (Brown (A4)), Try-in Paste (White), Try-in Paste (Opaque), Tooth Primer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kuraray Noritake Dental, Inc. · EMA Cement, Dental
Cleared on Aug 21, 2015 as substantially equivalent to K032455 (Kuraray Medical, Inc., 2003) and 5 other predicates after a 156-day review. Its family tree reaches back 12 generations to 1993. 2 later devices descend from it.
- Decided
- Aug 21, 2015
- Review
- 156 days
- Class
- Class II
- Product code
- EMA
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 12 generations to K931812 (1993). 76 ancestors in all, the oldest K832497 (1983). 2 later devices descend from it, 2 citing it directly.
- Root · 12 generations backK931812 New Dentine AdhesiveDentsply Intl. · 1993
- 8 generations between
- 3 generations backK081583 Clearfil SA CementKuraray Medical, Inc. · 2008
- 2 generations backK111982 Clearfil DC Core PlusKuraray America, Inc. · 2011
- 1 generation backK142625 PANAVIA SA Cement Plus Automix; (Universal (A2), White…Kuraray Noritake Dental, Inc. · 2015
- This deviceK150704 PANAVIA V5: Standard Kit (Universal (A2)), Standard Kit (Clear)…Kuraray Noritake Dental, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK210504 PANAVIA Veneer LCKuraray Noritake Dental, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK191524 Visalys Tooth PrimerKettenbach GmbH & Co. KG · 2019
Show all 12 generations
- Root · 12 generations backK931812 New Dentine AdhesiveDentsply Intl. · 1993
- 11 generations backK960823 Prime & Bond 2.0 Multipurpose Dentin/Enamel Bonding AgentDentsply Intl. · 1996
- 10 generations backK962348 Prime & Bond 2.1 Multipurpose Dentin/Enamel Bonding AgentDentsply Intl. · 1996
- 9 generations backK964525 Prime & Bond 2.1 M.P. Dentin/Enamel Bonding Agent W/ActivatorDentsply Intl. · 1997
- 8 generations backK974486 Clearfil Liner Bond 2VKuraray America, Inc. · 1998
- 7 generations backK990040 Clearfil SE BondKuraray Co. · 1999
- 6 generations backK012442 Modification to Clearfil SE BondKuraray Medical, Inc. · 2001
- 5 generations backK032455 Panavia F 2.0Kuraray Medical, Inc. · 2003
- 4 generations backK062410 Clearfil Esthetic Cement & DC BondKuraray Medical, Inc. · 2006
- 3 generations backK081583 Clearfil SA CementKuraray Medical, Inc. · 2008
- 2 generations backK111982 Clearfil DC Core PlusKuraray America, Inc. · 2011
- 1 generation backK142625 PANAVIA SA Cement Plus Automix; (Universal (A2), White…Kuraray Noritake Dental, Inc. · 2015
- This deviceK150704 PANAVIA V5: Standard Kit (Universal (A2)), Standard Kit (Clear)…Kuraray Noritake Dental, Inc. · 2015
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K931812 | New Dentine Adhesive | Dentsply Intl. | 1993 | — |
| −11 | K960823 | Prime & Bond 2.0 Multipurpose Dentin/Enamel Bonding Agent | Dentsply Intl. | 1996 | — |
| −10 | K962348 | Prime & Bond 2.1 Multipurpose Dentin/Enamel Bonding Agent | Dentsply Intl. | 1996 | — |
| −9 | K964525 | Prime & Bond 2.1 M.P. Dentin/Enamel Bonding Agent W/Activator | Dentsply Intl. | 1997 | — |
| −8 | K974486 | Clearfil Liner Bond 2V | Kuraray America, Inc. | 1998 | — |
| −7 | K990040 | Clearfil SE Bond | Kuraray Co. | 1999 | — |
| −6 | K012442 | Modification to Clearfil SE Bond | Kuraray Medical, Inc. | 2001 | — |
| −5 | K032455 | Panavia F 2.0 | Kuraray Medical, Inc. | 2003 | — |
| −4 | K062410 | Clearfil Esthetic Cement & DC Bond | Kuraray Medical, Inc. | 2006 | — |
| −3 | K081583 | Clearfil SA Cement | Kuraray Medical, Inc. | 2008 | — |
| −2 | K111982 | Clearfil DC Core Plus | Kuraray America, Inc. | 2011 | — |
| −1 | K142625 | PANAVIA SA Cement Plus Automix; (Universal (A2), White, Translucent); Value… | Kuraray Noritake Dental, Inc. | 2015 | — |
| 0 (this device) | K150704 | PANAVIA V5: Standard Kit (Universal (A2)), Standard Kit (Clear), Introductory… | Kuraray Noritake Dental, Inc. | 2015 | — |
| +1 | K210504 | PANAVIA Veneer LC | Kuraray Noritake Dental, Inc. | 2021 | — |
| +1 | K191524 | Visalys Tooth Primer | Kettenbach GmbH & Co. KG | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1984 | 1 | 0 |
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 4 | 0 |
| 1991 | 2 | 0 |
| 1992 | 2 | 0 |
| 1993 | 4 | 0 |
| 1994 | 7 | 0 |
| 1995 | 4 | 0 |
| 1996 | 4 | 0 |
| 1997 | 3 | 0 |
| 1998 | 6 | 0 |
| 1999 | 4 | 0 |
| 2000 | 1 | 0 |
| 2001 | 6 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 5 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 2 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 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? (6)
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 4…EMA) 3) Common name Adhesive resin cement system 3-3. Predicate devices 1) PANAVIA F 2.0 (Primary predicate) 510(k) Number K032455 Classification: Dental cement Produ… | 2003 |
| * | K142625 | PANAVIA SA Cement Plus Automix; (Universal (A2), White, Translucent); Value Pack…Summary page 4…72.3275 Applicant: Kuraray Noritake Dental Inc. 2) PANAVIA SA Cement Plus Automix 510(k) Number: K142625 Classification: Dental cement Produ… | 2015 |
| * | K012740 | Clearfil AP-XSummary page 4…72.3275 Applicant: Kuraray Noritake Dental Inc. 3) CLEARFIL AP-X 510(k) Number: K012740 Classification: Tooth shade resin material… | 2001 |
| * | K062410 | Clearfil Esthetic Cement & DC BondSummary page 4…nt: Kuraray Noritake Dental Inc. 4) CLEARFIL ESTHETIC CEMENT 510(k) Number: EX K062410 Classification: Dental cement Produ… | 2006 |
| * | K042929 | Estenia C&BSummary page 4…72.3275 Applicant: Kuraray Noritake Dental Inc. 5) ESTENIA C&B 510(k) Number: K042929 Classification: Tooth shade resin material… | 2004 |
| * | K033938 | Clearfil Protect BondSummary page 5…Section 3: Summary 6) CLEARFIL SE Protect 510(k) Number: K033938 Classification: Resin Tooth Bonding Agent… | 2004 |
What descends from it? (2)
2 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 22 years and passes through 5 companies; a new generation was cleared every 2.2 years on median.
- 1 of the 76 ancestors has a recall of any class.
- Of its descendants, K210504 (Kuraray Noritake Dental, Inc., 2021) has gone furthest, with 0 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. 2015, 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?
[1] Cementation of crowns, bridges, inlays and onlays
[2] Cementation of veneers
[3] Cementation of adhesion bridges and splints
[4] Cementation of prosthetic restorations on implant abutments and frames
[5] Cementation of posts and cores
[6] Amalgam bonding
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150704 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150704: PANAVIA V5: Standard Kit (Universal (A2)), Standard Kit (Clear), Introductory Kit (Universal (A2)), Introductory Kit (Clear), Sample Pack (Universal (A2)), Paste (Universal (A2)), Paste (Clear), Paste (Brown (A4)), Paste (White), Paste (Opaque), Try-in Paste (Universal (A2)), Try-in Paste (Clear), Try-in Paste (Brown (A4)), Try-in Paste (White), Try-in Paste (Opaque), Tooth Primer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150704
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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