510(k) · Cleared
ClearedBiscem Translucent, Model D-45011; Biscem Opaque, Model D-45012
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bisco, Inc. · EMA Cement, Dental
Cleared on Sep 25, 2008 after a 31-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 6 later devices descend from it.
- Decided
- Sep 25, 2008
- Review
- 31 days
- Class
- Class II
- Product code
- EMA
- Recalls
- None
- Predicates
- 1
6 later devices descend from it, 4 citing it directly.
- This deviceK082449 Biscem Translucent, Model D-45011; Biscem Opaque, Model D-45012Bisco, Inc. · 2008
- Descendant · cites it directly · 1 of its ownK231552 Dia-CemDiaDent Group International · 2023
- Descendant · cites it directly · 1 of its ownK161256 TheraCemBisco, Inc. · 2016
- Descendant · 2 generations on · 0 of its ownK254201 Any-CemMediclus Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK261166 Dia-CemDiaDent Group International · 2026
- Descendant · cites it directly · 0 of its ownK193260 U-Cem Premium & MAZIC CemVericom Co., Ltd. · 2020
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K231552Dia-CemDiaDent Group International · 2023 · cites it directly1descendant
- K161256TheraCemBisco, Inc. · 2016 · cites it directly1descendant
- K254201Any-CemMediclus Co., Ltd. · 2026 · 2 generations on0descendants
- K261166Dia-CemDiaDent Group International · 2026 · cites it directly0descendants
- K193260U-Cem Premium & MAZIC CemVericom Co., Ltd. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K082449 | Biscem Translucent, Model D-45011; Biscem Opaque, Model D-45012 | Bisco, Inc. | 2008 | — |
| +1 | K231552 | Dia-Cem | DiaDent Group International | 2023 | — |
| +1 | K161256 | TheraCem | Bisco, Inc. | 2016 | — |
| +2 | K254201 | Any-Cem | Mediclus Co., Ltd. | 2026 | — |
| +1 | K261166 | Dia-Cem | DiaDent Group International | 2026 | — |
| +1 | K193260 | U-Cem Premium & MAZIC Cem | Vericom Co., Ltd. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2020 | 2 | 0 |
| 2023 | 1 | 0 |
| 2026 | 2 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K061700 | FDA’s K061700 is Neotract Anchor Our reading of the summary gave K061700, FDA’s number for Neotract Anchor (Neotract, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “BisCem”. Kept off the family tree. | 2006 |
What descends from it? (6)
4 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?
- Of its descendants, K231552 (DiaDent Group International, 2023) has gone furthest, with 1 descendant of its own.
How does its category compare?
All EMA devicesEMA Cement, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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. Luting metal crowns, bridges, inlays, and onlays including porcelain-fused-to-metal and composite-to-metal varieties;
2. Luting resin crowns, bridges, inlays, onlays and veneers;
3. Luting metal or non-metal/fiber posts;
4. Luting orthodontic appliances;
5. Luting porcelain inlays, onlays, crowns, and veneers (includes alumina and zirconia).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082449 · printed Nov 5, 2026
Cite this page
510(k) Report. “K082449: Biscem Translucent, Model D-45011; Biscem Opaque, Model D-45012.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K082449
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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