510(k) · Cleared
ClearedMetacem
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Meta Biomed Co., Ltd. · EMA Cement, Dental
Cleared on May 15, 2018 as substantially equivalent to K081913 (Meta Biomed Co., Ltd., 2008) after a 363-day review. Its family tree reaches back 9 generations to 1993. 1 later device descends from it.
- Decided
- May 15, 2018
- Review
- 363 days
- Class
- Class II
- Product code
- EMA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K931812 (1993). 48 ancestors in all, the oldest K871636 (1987). 1 later device descends from it, 1 citing it directly.
- Root · 9 generations backK931812 New Dentine AdhesiveDentsply Intl. · 1993
- 5 generations between
- 3 generations backK012442 Modification to Clearfil SE BondKuraray Medical, Inc. · 2001
- 2 generations backK024356 Clearfil Silane KitKuraray Medical, Inc. · 2003
- 1 generation backK081913 Metacem, Meta P&Bond, Metacem Silane Ceramic PrimerMeta Biomed Co., Ltd. · 2008
- This deviceK171449 MetacemMeta Biomed Co., Ltd. · 2018
- Descendant · cites it directly · 0 of its ownK261166 Dia-CemDiaDent Group International · 2026
Show all 9 generations
- Root · 9 generations backK931812 New Dentine AdhesiveDentsply Intl. · 1993
- 8 generations backK960823 Prime & Bond 2.0 Multipurpose Dentin/Enamel Bonding AgentDentsply Intl. · 1996
- 7 generations backK962348 Prime & Bond 2.1 Multipurpose Dentin/Enamel Bonding AgentDentsply Intl. · 1996
- 6 generations backK964525 Prime & Bond 2.1 M.P. Dentin/Enamel Bonding Agent W/ActivatorDentsply Intl. · 1997
- 5 generations backK974486 Clearfil Liner Bond 2VKuraray America, Inc. · 1998
- 4 generations backK990040 Clearfil SE BondKuraray Co. · 1999
- 3 generations backK012442 Modification to Clearfil SE BondKuraray Medical, Inc. · 2001
- 2 generations backK024356 Clearfil Silane KitKuraray Medical, Inc. · 2003
- 1 generation backK081913 Metacem, Meta P&Bond, Metacem Silane Ceramic PrimerMeta Biomed Co., Ltd. · 2008
- This deviceK171449 MetacemMeta Biomed Co., Ltd. · 2018
Most influential descendants
Showing 1 of 1 · See all- K261166Dia-CemDiaDent Group International · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K931812 | New Dentine Adhesive | Dentsply Intl. | 1993 | — |
| −8 | K960823 | Prime & Bond 2.0 Multipurpose Dentin/Enamel Bonding Agent | Dentsply Intl. | 1996 | — |
| −7 | K962348 | Prime & Bond 2.1 Multipurpose Dentin/Enamel Bonding Agent | Dentsply Intl. | 1996 | — |
| −6 | K964525 | Prime & Bond 2.1 M.P. Dentin/Enamel Bonding Agent W/Activator | Dentsply Intl. | 1997 | — |
| −5 | K974486 | Clearfil Liner Bond 2V | Kuraray America, Inc. | 1998 | — |
| −4 | K990040 | Clearfil SE Bond | Kuraray Co. | 1999 | — |
| −3 | K012442 | Modification to Clearfil SE Bond | Kuraray Medical, Inc. | 2001 | — |
| −2 | K024356 | Clearfil Silane Kit | Kuraray Medical, Inc. | 2003 | — |
| −1 | K081913 | Metacem, Meta P&Bond, Metacem Silane Ceramic Primer | Meta Biomed Co., Ltd. | 2008 | — |
| 0 (this device) | K171449 | Metacem | Meta Biomed Co., Ltd. | 2018 | — |
| +1 | K261166 | Dia-Cem | DiaDent Group International | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 3 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 6 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1998 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 5 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K081913 | Metacem, Meta P&Bond, Metacem Silane Ceramic PrimerSummary page 4…evice Class: Class II • Date prepared: 05/08/2018 Predicate Devices: The subject device is substantially equivalent to the following predicate devices: • K081913, Metacem manufactured by Meta Biomed Co., Ltd. General Description Metacem is a high strength, permanent visible light cured (… | 2008 |
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 |
|---|---|---|---|
| K261166 | Dia-Cem | 2026 | 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 25 years and passes through 5 companies; a new generation was cleared every 1.5 years on median.
- 2 of the 48 ancestors have a recall of any class.
- Of its descendants, K261166 (DiaDent Group International, 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K081913.
How does its category compare?
All EMA devicesEMA Cement, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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?
Adhesive cementation of:
* Crown & Bridges (Ceramic, Composite, Porcelain, Metal)
* Inlay / Onlay cementation
* Bonding for porcelain veneers
* Endodontic posts cementation
* Core build up
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/K171449 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171449: Metacem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171449
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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