510(k) · Cleared

Cleared

Optibond

K940513510(k) TraditionalCleared Apr 15, 199470-day reviewClass II21 CFR 872.3200

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

Kerr Corporation (Danbury) · KLE Agent, Tooth Bonding, Resin

Cleared on Apr 15, 1994 after a 70-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 8 later devices descend from it.

Decided: Apr 15, 1994
Review: 70 days
Class: Class II
Product code: KLE
Recalls: None
Predicates: 0

8 later devices descend from it, 3 citing it directly.

This deviceK940513 OptibondKerr Corporation (Danbury) · 1994
Descendant · cites it directly · 5 of its ownK012316 Permacem / Permacem DualDmg USA, Inc. · 2001
Descendant · 2 generations on · 1 of its ownK121804 Provitemp, Dentotemp, Totalcem, DentocemItena Clinical · 2013
Descendant · 2 generations on · 1 of its ownK041960 Composite/Compomer Repair KitDmg USA, Inc. · 2004
Descendant · 3 generations on · 0 of its ownK162960 TotalC-RamItena Clinical · 2017
Descendant · 3 generations on · 0 of its ownK063444 Total Etch Bonding AgentDmg USA, Inc. · 2007

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

1998high 2 (1998) · low 0 (1999)2026

Most influential descendants

Showing 5 of 8 · See all

K012316Permacem / Permacem DualDmg USA, Inc. · 2001 · cites it directly5descendants
K121804Provitemp, Dentotemp, Totalcem, DentocemItena Clinical · 2013 · 2 generations on1descendant
K041960Composite/Compomer Repair KitDmg USA, Inc. · 2004 · 2 generations on1descendant
K162960TotalC-RamItena Clinical · 2017 · 3 generations on0descendants
K063444Total Etch Bonding AgentDmg USA, Inc. · 2007 · 3 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K940513	Optibond	Kerr Corporation (Danbury)	1994	—
+1	K012316	Permacem / Permacem Dual	Dmg USA, Inc.	2001	—
+2	K121804	Provitemp, Dentotemp, Totalcem, Dentocem	Itena Clinical	2013	—
+2	K041960	Composite/Compomer Repair Kit	Dmg USA, Inc.	2004	—
+3	K162960	TotalC-Ram	Itena Clinical	2017	—
+3	K063444	Total Etch Bonding Agent	Dmg USA, Inc.	2007	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	2	0
2001	1	0
2003	1	0
2004	1	0
2007	1	0
2013	1	0
2017	1	0

FIG. 1 — Lineage of K940513, 1994–2017Source: 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 KLE? 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 KLE device

#1 K262252 MPa Max adhesivescore 15.1 · 11 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 has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (8)

3 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
K982692	Sternomega Bonding Agent, Sternomega Composite LC, Sternomega Compomer LC	Sterngold/Implamed	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 KLE devices

KLE Agent, Tooth Bonding, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KLE

3in 2025

2007high 14 (2007) · low 3 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KLE

149in 2025

2007high 195 (2020) · low 61 (2024)2026

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

Recalls per year · KLE

1in 2024

2007high 2 (2007) · low 0 (2008)2026

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

Adverse event reports per year · KLE

3in 2025

2007high 260 (2014) · low 3 (2025)2025

MAUDE reports naming product code KLE, 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	14	71	2	18
2008	3	66	0	9
2009	7	79	1	11
2010	8	93	1	13
2011	10	100	0	69
2012	5	66	0	176
2013	11	115	0	248
2014	6	120	0	260
2015	10	118	0	100
2016	3	148	1	47
2017	4	171	1	42
2018	8	124	0	31
2019	6	143	0	20
2020	6	195	0	6
2021	4	163	0	6
2022	8	98	0	7
2023	6	75	0	7
2024	7	61	1	12
2025	3	149	0	3
2026	7	84	0	—

https://510kreport.com/device/K940513 · printed Nov 6, 2026

Cite this page

510(k) Report. “K940513: Optibond.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K940513

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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