510(k) · Cleared

Cleared

Bistite II SC

K991711510(k) TraditionalCleared Jul 7, 199949-day reviewClass II21 CFR 872.3275

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Tokuyama America, Inc. · EMA Cement, Dental

Cleared on Jul 7, 1999 as substantially equivalent to K933030 (Kuraray Co., 1994) and 2 other predicates after a 49-day review. Its family tree reaches back 1 generation to 1986. 5 later devices descend from it.

Decided: Jul 7, 1999
Review: 49 days
Class: Class II
Product code: EMA
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K855211 (1986). 3 ancestors in all. 5 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK855211 Panavia EX, a Dental AdhesiveKuraray Co. · 1986
This deviceK991711 Bistite II SCTokuyama America, Inc. · 1999
Descendant · cites it directly · 3 of its ownK011685 Bistite II DCTokuyama America, Inc. · 2001
Descendant · 2 generations on · 2 of its ownK150727 EstecemTokuyama Dental Corporation · 2015
Descendant · 3 generations on · 1 of its ownK171226 Tokuyama Universal BondTokuyama Dental Corporation · 2017
Descendant · 4 generations on · 0 of its ownK203760 Tokuyama Universal Bond IITokuyama Dental Corporation · 2021
Descendant · cites it directly · 0 of its ownK011854 Tokuyama M-BondTokuyama America, Inc. · 2001

Most influential descendants

Showing 5 of 5 · See all

K011685Bistite II DCTokuyama America, Inc. · 2001 · cites it directly3descendants
K150727EstecemTokuyama Dental Corporation · 2015 · 2 generations on2descendants
K171226Tokuyama Universal BondTokuyama Dental Corporation · 2017 · 3 generations on1descendant
K203760Tokuyama Universal Bond IITokuyama Dental Corporation · 2021 · 4 generations on0descendants
K011854Tokuyama M-BondTokuyama America, Inc. · 2001 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K855211	Panavia EX, a Dental Adhesive	Kuraray Co.	1986	—
0 (this device)	K991711	Bistite II SC	Tokuyama America, Inc.	1999	—
+1	K011685	Bistite II DC	Tokuyama America, Inc.	2001	—
+2	K150727	Estecem	Tokuyama Dental Corporation	2015	—
+3	K171226	Tokuyama Universal Bond	Tokuyama Dental Corporation	2017	—
+4	K203760	Tokuyama Universal Bond II	Tokuyama Dental Corporation	2021	—
+1	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

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2001	2	0
2015	1	0
2017	1	0
2021	1	0

FIG. 1 — Lineage of K991711, 1986–2021Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) 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	Applicant	Decided	Recalls
*	K933030	Panavia 21 Summary page 1 …ceived the approval of the Japanese Government. It is substantially equivalent to various marketed dental cement products, including the following: Panavia 21 (Kurarey) K933030 Panavia Ex (Kurarey) K855211 C&B Metabond (Parkell) K960464 The Use of the product is contra-indicated for patients who are hype…	Kuraray Co.	1994	—
*	K855211	Panavia EX, a Dental Adhesive Summary page 1 …panese Government. It is substantially equivalent to various marketed dental cement products, including the following: Panavia 21 (Kurarey) K933030 Panavia Ex (Kurarey) K855211 C&B Metabond (Parkell) K960464 The Use of the product is contra-indicated for patients who are hypersensitive to methacrylate mo…	Kuraray Co.	1986	—
*	K960464	C & B Metabond (Modification) Summary page 1 …ntially equivalent to various marketed dental cement products, including the following: Panavia 21 (Kurarey) K933030 Panavia Ex (Kurarey) K855211 C&B Metabond (Parkell) K960464 The Use of the product is contra-indicated for patients who are hypersensitive to methacrylate monomers. It should not be allowe…	Parkell, Inc.	1996	—

Also cleared against K933030: 5 other devices →

What descends from it? (5)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K011685	Bistite II DC	Tokuyama America, Inc.	2001	3
K011854	Tokuyama M-Bond	Tokuyama America, Inc.	2001	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?

None of the 3 ancestors has a recall.
Of its descendants, K011685 (Tokuyama America, Inc., 2001) has gone furthest, with 3 descendants of its own.
5 other devices also cite its predicate K933030.

How does its category compare?

All EMA devices

EMA Cement, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EMA

10in 2025

2007high 14 (2010) · low 2 (2023)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EMA

106in 2025

2007high 245 (2022) · low 48 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · EMA

1in 2023

2007high 5 (2011) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · EMA

9in 2025

2007high 385 (2013) · low 3 (2022)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 porcelains or crown and bridge resins, cementaiton 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/K991711 · printed Nov 5, 2026

Cite this page

510(k) Report. “K991711: Bistite II SC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K991711

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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