510(k) · Cleared
ClearedTokuyama M-Bond
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 Sep 4, 2001 as substantially equivalent to K991711 (Tokuyama America, Inc., 1999) and 2 other predicates after an 83-day review. Its family tree reaches back 2 generations to 1986.
- Decided
- Sep 4, 2001
- Review
- 83 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. No later device cites it as a predicate yet.
View 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) | K011854 | Tokuyama M-Bond | Tokuyama America, Inc. | 2001 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1996 | 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 Il SC (Tokuyama) K991711 C&B Metabond (Parkhill) K960464 Panavia 21 (Kurarey) K933030 The use of the product is contra-indicated for patients who are hyp… | 1999 |
| * | K960464 | C & B Metabond (Modification)Summary page 1…Government. It is substantially equivalent to various marketed dental cement products, including the following: Bistite Il SC (Tokuyama) K991711 C&B Metabond (Parkhill) K960464 Panavia 21 (Kurarey) K933030 The use of the product is contra-indicated for patients who are hypersensitive to methacrylate mono… | 1996 |
| * | K933030 | Panavia 21Summary page 1…ly equivalent to various marketed dental cement products, including the following: Bistite Il SC (Tokuyama) K991711 C&B Metabond (Parkhill) K960464 Panavia 21 (Kurarey) K933030 The use of the product is contra-indicated for patients who are hypersensitive to methacrylate monomers. It should not be allowe… | 1994 |
What descends from it?
No later submission names this one as a predicate yet.
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.
- 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 for adhesion and fixation between tooth and prosthesis, tooth and tooth, and between two or more prostheses.
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/K011854 · printed Nov 6, 2026
Cite this page
510(k) Report. “K011854: Tokuyama M-Bond.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011854
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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