510(k) · Cleared
ClearedPANAVIA SA Cement Universal
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 Apr 25, 2019 as substantially equivalent to K142625 (Kuraray Noritake Dental, Inc., 2015) after a 127-day review. Its family tree reaches back 12 generations to 1993.
- Decided
- Apr 25, 2019
- Review
- 127 days
- Class
- Class II
- Product code
- EMA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K931812 (1993). 70 ancestors in all, the oldest K833757 (1984). No later device cites it as a predicate yet.
- 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 deviceK183537 PANAVIA SA Cement UniversalKuraray Noritake Dental, Inc. · 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 deviceK183537 PANAVIA SA Cement UniversalKuraray Noritake Dental, Inc. · 2019
View 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) | K183537 | PANAVIA SA Cement Universal | Kuraray Noritake Dental, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 4 | 0 |
| 1991 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 7 | 0 |
| 1995 | 4 | 0 |
| 1996 | 4 | 0 |
| 1997 | 3 | 0 |
| 1998 | 5 | 0 |
| 1999 | 4 | 0 |
| 2000 | 1 | 0 |
| 2001 | 6 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 4 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 2 | 0 |
| 2012 | 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 |
|---|---|---|---|
| * | K142625 | PANAVIA SA Cement Plus Automix; (Universal (A2), White, Translucent); Value Pack…Summary page 4…EMA) 3) Common name Dental adhesive resin cement 3-3. Predicate device 1) PANAVIA SA Cement Plus Automix 510(k) Number K142625 Classification: Dental cement Produ… | 2015 |
| † | K130371 | Clearfil Majesty ES Flow | 2013 |
| † | K142623 | PANAVIA SA Cement Plus Handmix | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
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 26 years and passes through 5 companies; a new generation was cleared every 2.6 years on median.
- 1 of the 70 ancestors has a recall of any class.
- 1 other device also cites its predicate K142625.
How does its category compare?
All EMA devicesEMA Cement, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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?
PANAVIA SA Cement Universal is indicated for the following uses:
[1] Cementation of crowns, bridges, inlays and onlays
[2] Cementation of prosthetic restorations on implant abutments and frames
[3] Cementation of adhesion bridges and splints
[4] Cementation of posts and cores
[5] Amalgam bonding
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K183537 · printed Nov 5, 2026
Cite this page
510(k) Report. “K183537: PANAVIA SA Cement Universal.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K183537
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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