510(k) · Cleared
ClearedBistite II DC
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tokuyama America, Inc. · EMA Cement, Dental
Cleared on Jul 31, 2001 as substantially equivalent to K991711 (Tokuyama America, Inc., 1999) and 2 other predicates after a 61-day review. Its family tree reaches back 2 generations to 1986. 3 later devices descend from it.
- Decided
- Jul 31, 2001
- Review
- 61 days
- Class
- Class II
- Product code
- EMA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K855211 (1986). 4 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK855211 Panavia EX, a Dental AdhesiveKuraray Co. · 1986
- 1 generation backK991711 Bistite II SCTokuyama America, Inc. · 1999
- This deviceK011685 Bistite II DCTokuyama America, Inc. · 2001
- Descendant · cites it directly · 2 of its ownK150727 EstecemTokuyama Dental Corporation · 2015
- Descendant · 2 generations on · 1 of its ownK171226 Tokuyama Universal BondTokuyama Dental Corporation · 2017
- Descendant · 3 generations on · 0 of its ownK203760 Tokuyama Universal Bond IITokuyama Dental Corporation · 2021
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K855211 | Panavia EX, a Dental Adhesive | Kuraray Co. | 1986 | — |
| −1 | K991711 | Bistite II SC | Tokuyama America, Inc. | 1999 | — |
| 0 (this device) | K011685 | Bistite II DC | Tokuyama America, Inc. | 2001 | — |
| +1 | K150727 | Estecem | Tokuyama Dental Corporation | 2015 | — |
| +2 | K171226 | Tokuyama Universal Bond | Tokuyama Dental Corporation | 2017 | — |
| +3 | 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 |
|---|---|---|
| 2015 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K991711 | Bistite II SCSummary page 1…ed the approval of the Japanese Government. It is substantially equivalent to various marketed dental cement products, including the following: Bistite 1| SC (Tokuyama) K991711 Panavia 21 (Kurarey) K933030 C&B Metabond (Parkhill) K960464 The use of the product is contra-indicated for patients who are hyp… | 1999 |
| * | K933030 | Panavia 21Summary page 1…se Government. It is substantially equivalent to various marketed dental cement products, including the following: Bistite 1| SC (Tokuyama) K991711 Panavia 21 (Kurarey) K933030 C&B Metabond (Parkhill) K960464 The use of the product is contra-indicated for patients who are hypersensitive to methacrylate m… | 1994 |
| * | K960464 | C & B Metabond (Modification)Summary page 1…ly equivalent to various marketed dental cement products, including the following: Bistite 1| SC (Tokuyama) K991711 Panavia 21 (Kurarey) K933030 C&B Metabond (Parkhill) K960464 The use of the product is contra-indicated for patients who are hypersensitive to methacrylate monomers. It should not be allowe… | 1996 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K150727 | Estecem | 2015 | 2 |
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 15 years and passes through 2 companies; a new generation was cleared every 13.3 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K150727 (Tokuyama Dental Corporation, 2015) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K991711.
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?
For use as a dental cement in various applications, including luting, repair of fractured procelains or crown and bridge resins, cemtation of adhesive bridge prostheses and CR core 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/K011685 · printed Nov 6, 2026
Cite this page
510(k) Report. “K011685: Bistite II DC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011685
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026