510(k) · Cleared
ClearedCalibra Cement
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentsply Intl. · EMA Cement, Dental
Cleared on Jun 16, 2004 as substantially equivalent to K940459 (Dentsply Intl., 1994) after a 70-day review. Its family tree reaches back 1 generation to 1994. 8 later devices descend from it.
- Decided
- Jun 16, 2004
- Review
- 70 days
- Class
- Class II
- Product code
- EMA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K940459 (1994). 8 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK940459 Multipurpose Resin Cement with Fluoride (MRCF)Dentsply Intl. · 1994
- This deviceK040906 Calibra CementDentsply Intl. · 2004
- Descendant · cites it directly · 3 of its ownK081913 Metacem, Meta P&Bond, Metacem Silane Ceramic PrimerMeta Biomed Co., Ltd. · 2008
- Descendant · 2 generations on · 1 of its ownK171449 MetacemMeta Biomed Co., Ltd. · 2018
- Descendant · cites it directly · 1 of its ownK101787 Duolink IIBisco, Inc. · 2010
- Descendant · cites it directly · 1 of its ownK083326 Fluorocore 2Dentsply International, Inc. · 2009
- Descendant · 3 generations on · 0 of its ownK261166 Dia-CemDiaDent Group International · 2026
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K081913Metacem, Meta P&Bond, Metacem Silane Ceramic PrimerMeta Biomed Co., Ltd. · 2008 · cites it directly3descendants
- K171449MetacemMeta Biomed Co., Ltd. · 2018 · 2 generations on1descendant
- K101787Duolink IIBisco, Inc. · 2010 · cites it directly1descendant
- K083326Fluorocore 2Dentsply International, Inc. · 2009 · cites it directly1descendant
- K261166Dia-CemDiaDent Group International · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K940459 | Multipurpose Resin Cement with Fluoride (MRCF) | Dentsply Intl. | 1994 | — |
| 0 (this device) | K040906 | Calibra Cement | Dentsply Intl. | 2004 | — |
| +1 | K081913 | Metacem, Meta P&Bond, Metacem Silane Ceramic Primer | Meta Biomed Co., Ltd. | 2008 | — |
| +2 | K171449 | Metacem | Meta Biomed Co., Ltd. | 2018 | — |
| +1 | K101787 | Duolink II | Bisco, Inc. | 2010 | — |
| +1 | K083326 | Fluorocore 2 | Dentsply International, Inc. | 2009 | — |
| +3 | K261166 | Dia-Cem | DiaDent Group International | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2018 | 2 | 0 |
| 2025 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K940459 | Multipurpose Resin Cement with Fluoride (MRCF)Summary page 1…CALIBRATM CEMENT CLASSIFICATION NAME: Dental cement (872.3275) PREDICATE DEVICES: EnforceTM with Fluoride Cement K940459 DEVICE DESCRIPTION: CALIBRATm CEMENT is a visible light cured (VLC), dual-cured, or self-cured high strength cement… | 1994 |
What descends from it? (8)
3 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?
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?
Adhesive cementation of:
1) ceramic, porcelain, or composite inlays/onlays, veneers, or crowns;
2) all metal crowns, bridges, inlays/onlays including precious, semi-precious,
and non-precious metals;
3) PFM (porcelain fused to metal) crowns and bridges;
4) prefabricated and cast posts; and
5) resin-bonded retainer bridges (Maryland bridges)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040906 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040906: Calibra Cement.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040906
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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