510(k) · Cleared
ClearedEstecem
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tokuyama Dental Corporation · EMA Cement, Dental
Cleared on Jun 17, 2015 as substantially equivalent to K011685 (Tokuyama America, Inc., 2001) after an 89-day review. Its family tree reaches back 3 generations to 1986. 2 later devices descend from it.
- Decided
- Jun 17, 2015
- Review
- 89 days
- Class
- Class II
- Product code
- EMA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K855211 (1986). 5 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK855211 Panavia EX, a Dental AdhesiveKuraray Co. · 1986
- 2 generations backK991711 Bistite II SCTokuyama America, Inc. · 1999
- 1 generation backK011685 Bistite II DCTokuyama America, Inc. · 2001
- This deviceK150727 EstecemTokuyama Dental Corporation · 2015
- Descendant · cites it directly · 1 of its ownK171226 Tokuyama Universal BondTokuyama Dental Corporation · 2017
- Descendant · 2 generations on · 0 of its ownK203760 Tokuyama Universal Bond IITokuyama Dental Corporation · 2021
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K855211 | Panavia EX, a Dental Adhesive | Kuraray Co. | 1986 | — |
| −2 | K991711 | Bistite II SC | Tokuyama America, Inc. | 1999 | — |
| −1 | K011685 | Bistite II DC | Tokuyama America, Inc. | 2001 | — |
| 0 (this device) | K150727 | Estecem | Tokuyama Dental Corporation | 2015 | — |
| +1 | K171226 | Tokuyama Universal Bond | Tokuyama Dental Corporation | 2017 | — |
| +2 | K203760 | Tokuyama Universal Bond II | Tokuyama Dental Corporation | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2021 | 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.
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K171226 | Tokuyama Universal Bond | 2017 | 1 |
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 29 years and passes through 3 companies; a new generation was cleared every 13.3 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K171226 (Tokuyama Dental Corporation, 2017) 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. 2015, 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?
The ESTECEM device is an adhesive resin cement for the cementation of crowns, bridges, inlays, and onlays made of glass/oxide ceramics (porcelain, zirconia and alumina), metals/alloys (precious and non-precious) and resin materials including inorganic filler (composite materials). The ESTECEM device is indicated for:
- Repair of fractured porcelain fused to metal crowns and all ceramic restorations
- Cementation of veneers
- Cementation of adhesion bridges
- Cementation of metal or resin cores, metal or glass-fiber posts
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/K150727 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150727: Estecem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150727
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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