510(k) · Cleared
ClearedDuolink II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bisco, Inc. · EMA Cement, Dental
Cleared on Oct 8, 2010 as substantially equivalent to K934596 (Bisco, Inc., 1994) and 2 other predicates after a 105-day review. Its family tree reaches back 3 generations to 2000. 1 later device descends from it.
- Decided
- Oct 8, 2010
- Review
- 105 days
- Class
- Class II
- Product code
- EMA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K002364 (2000). 7 ancestors in all, the oldest K934596 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK002364 Protemp HEspe Dental AG · 2000
- 2 generations backK062292 Unicem3M Espe Dental Products · 2006
- 1 generation backK093338 Self Adhesive Composite Luting CementDmg USA, Inc. · 2010
- This deviceK101787 Duolink IIBisco, Inc. · 2010
- Descendant · cites it directly · 0 of its ownK250156 Choice 2 DCBisco, Inc. · 2025
Most influential descendants
Showing 1 of 1 · See all- K250156Choice 2 DCBisco, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K002364 | Protemp H | Espe Dental AG | 2000 | — |
| −2 | K062292 | Unicem | 3M Espe Dental Products | 2006 | — |
| −1 | K093338 | Self Adhesive Composite Luting Cement | Dmg USA, Inc. | 2010 | — |
| 0 (this device) | K101787 | Duolink II | Bisco, Inc. | 2010 | — |
| +1 | K250156 | Choice 2 DC | Bisco, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 2004 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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? (3)
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 |
|---|---|---|---|
| * | K934596 | Bisco Duo Link D/C Luting CompositeSummary page 1…me: Dental Cement Class II per 21 CFR 872.3275 .Predicate Devices: Duolink by Bisco, Inc., Schaumburg IL K934596 Calibra by Dentsply Intl., York PA K040906 Self-Adhesive Lu… | 1994 |
| * | K040906 | Calibra CementSummary page 1…r 21 CFR 872.3275 .Predicate Devices: Duolink by Bisco, Inc., Schaumburg IL K934596 Calibra by Dentsply Intl., York PA K040906 Self-Adhesive Luting Cement by DM0 USA Inc., Ayer MA K093338 Description of the Applicant Dev… | 2004 |
| * | K093338 | Self Adhesive Composite Luting CementSummary page 1…596 Calibra by Dentsply Intl., York PA K040906 Self-Adhesive Luting Cement by DM0 USA Inc., Ayer MA K093338 Description of the Applicant Device/Indications for use: DuoLink II is a dual-cured, radio-apparent composite luting cement. T… | 2010 |
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 |
|---|---|---|---|
| K250156 | Choice 2 DC | 2025 | 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 10 years and passes through 4 companies; a new generation was cleared every 3.3 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K250156 (Bisco, Inc., 2025) has gone furthest, with 0 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. 2010, 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?
DuoLink II is a dual-cured, radio-apparent composite luting cement.
The indications of use of DuoLink H are to cement:
1. All indirect restorations (ie. crowns, bridges, inlay, and onlays fabricated from metal composite, porcelain, ceramic, zirconia, alumina, etc)
2. All endodontic posts (ie. fiber, composite, and metal)
3. All abutments (ie. screws)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101787 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101787: Duolink II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101787
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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