510(k) · Cleared

Cleared

C & B Metabond (Modification)

K960464510(k) TraditionalCleared Feb 26, 199627-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

Cleared on Feb 26, 1996 after a 27-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 15 later devices descend from it.

Decided: Feb 26, 1996
Review: 27 days
Class: Class II
Product code: EMA
Recalls: None
Predicates: 0

15 later devices descend from it, 7 citing it directly.

This deviceK960464 C & B Metabond (Modification)Parkell, Inc. · 1996
Descendant · cites it directly · 5 of its ownK012316 Permacem / Permacem DualDmg USA, Inc. · 2001
Descendant · cites it directly · 5 of its ownK991711 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

Showing 5 of 15 descendants. See all descendants

Descendants cleared per year

1998high 3 (2001) · low 0 (2000)2026

Most influential descendants

Showing 5 of 15 · See all

K012316Permacem / Permacem DualDmg USA, Inc. · 2001 · cites it directly5descendants
K991711Bistite II SCTokuyama America, Inc. · 1999 · cites it directly5descendants
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

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K960464	C & B Metabond (Modification)	Parkell, Inc.	1996	—
+1	K012316	Permacem / Permacem Dual	Dmg USA, Inc.	2001	—
+1	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	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	2	0
1999	1	0
2001	3	0
2003	1	0
2004	1	0
2006	1	0
2007	1	0
2013	1	0
2015	1	0
2017	2	0
2021	1	0

FIG. 1 — Lineage of K960464, 1996–2021Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (15)

See all 15

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

Number	Device	Applicant	Decided	Descendants
K012316	Permacem / Permacem Dual	Dmg USA, Inc.	2001	5
K991711	Bistite II SC	Tokuyama America, Inc.	1999	5
K011685	Bistite II DC	Tokuyama America, Inc.	2001	3
K063228	Surface Coat	Kuraray America, Inc.	2006	0
K011854	Tokuyama M-Bond	Tokuyama America, Inc.	2001	0
K983361	Panavia F	Kuraray America, Inc.	1998	0
K982895	Sternomega Compomer Cement	Sterngold/Implamed	1998	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?

Of its descendants, K012316 (Dmg USA, Inc., 2001) has gone furthest, with 5 descendants of its own.

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	—

https://510kreport.com/device/K960464 · printed Nov 4, 2026

Cite this page

510(k) Report. “K960464: C & B Metabond (Modification).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K960464

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026