510(k) · Cleared
Recalled · 2008Biscem Translucent, Biscem Opaque
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bisco, Inc. · EMA Cement, Dental
Cleared on May 15, 2006 as substantially equivalent to K032597 (Bisco, Inc., 2003) after a 60-day review. Its family tree reaches back 1 generation to 2003. 4 later devices descend from it. It has been recalled 2 times.
- Decided
- May 15, 2006
- Review
- 60 days
- Class
- Class II
- Product code
- EMA
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K032597 (2003). 4 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK032597 Biscem GIBisco, Inc. · 2003
- This deviceK060701 Biscem Translucent, Biscem OpaqueBisco, Inc. · 2006
- 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 · 3 generations on · 0 of its ownK261166 Dia-CemDiaDent Group International · 2026
- Descendant · 2 generations on · 0 of its ownK180802 Meta P&BondMeta Biomed Co., Ltd. · 2018
Most influential descendants
Showing 4 of 4 · 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
- K261166Dia-CemDiaDent Group International · 2026 · 3 generations on0descendants
- K180802Meta P&BondMeta Biomed Co., Ltd. · 2018 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K032597 | Biscem GI | Bisco, Inc. | 2003 | — |
| 0 (this device) | K060701 | Biscem Translucent, Biscem Opaque | Bisco, Inc. | 2006 | — |
| +1 | K081913 | Metacem, Meta P&Bond, Metacem Silane Ceramic Primer | Meta Biomed Co., Ltd. | 2008 | — |
| +2 | K171449 | Metacem | Meta Biomed Co., Ltd. | 2018 | — |
| +3 | K261166 | Dia-Cem | DiaDent Group International | 2026 | — |
| +2 | K180802 | Meta P&Bond | Meta Biomed Co., Ltd. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2018 | 2 | 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 |
|---|---|---|---|
| * | K032597 | Biscem GISummary page 1…dental cement designed to be used as a luting cement. Its physical properties and uses are similar to the predicate device. Predicate Devices: BisCemi GI cleared under (K032597) dated November 4, 2003. Significant Performance Characteristics: BisCem GI… | 2003 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081913 | Metacem, Meta P&Bond, Metacem Silane Ceramic Primer | 2008 | 3 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 28, 2008 | Not classified | Z-1696-2008 | Incorrect or no expiration date | During product stability testing, Bisco determined that after 15 months of storage, BISCEM Self-Adhesive Luting Cement used in self-cure mode only without light-curing may take longer than specified to set, resulting in reduced bond… |
| Apr 28, 2008 | Not classified | Z-1697-2008 | Incorrect or no expiration date | During product stability testing, Bisco determined that after 15 months of storage, BISCEM Self-Adhesive Luting Cement used in self-cure mode only without light-curing may take longer than specified to set, resulting in reduced bond… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K081913 (Meta Biomed Co., Ltd., 2008) has gone furthest, with 3 descendants 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.
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, inlay, 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/K060701 · printed Nov 5, 2026
Cite this page
510(k) Report. “K060701: Biscem Translucent, Biscem Opaque.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K060701
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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