510(k) · Cleared

Cleared

Ibond Gluma Inside

K022612510(k) TraditionalCleared Oct 28, 200283-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

Heraeus Kulzer, Inc. · KLE Agent, Tooth Bonding, Resin

Cleared on Oct 28, 2002 after an 83-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 later devices descend from it.

Decided: Oct 28, 2002
Review: 83 days
Class: Class II
Product code: KLE
Recalls: None
Predicates: 0

2 later devices descend from it, 1 citing it directly.

This deviceK022612 Ibond Gluma InsideHeraeus Kulzer, Inc. · 2002
Descendant · cites it directly · 1 of its ownK041960 Composite/Compomer Repair KitDmg USA, Inc. · 2004
Descendant · 2 generations on · 0 of its ownK063444 Total Etch Bonding AgentDmg USA, Inc. · 2007

Most influential descendants

Showing 2 of 2 · See all

K041960Composite/Compomer Repair KitDmg USA, Inc. · 2004 · cites it directly1descendant
K063444Total Etch Bonding AgentDmg USA, Inc. · 2007 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K022612	Ibond Gluma Inside	Heraeus Kulzer, Inc.	2002	—
+1	K041960	Composite/Compomer Repair Kit	Dmg USA, Inc.	2004	—
+2	K063444	Total Etch Bonding Agent	Dmg USA, Inc.	2007	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2007	1	0

FIG. 1 — Lineage of K022612, 2002–2007Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), 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
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#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K041960	Composite/Compomer Repair Kit	Dmg USA, Inc.	2004	1

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, K041960 (Dmg USA, Inc., 2004) has gone furthest, with 1 descendant 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	—

What is it indicated for?

Bonding composite, compomer and Polyglas resins to the tooth structure as well for indirect restorations (e.g. Artglass, porcelain) and sealing of prepared teeth prior to amalgam placement

Indications for use as stated in the FDA 510(k) statement.

https://510kreport.com/device/K022612 · printed Nov 6, 2026

Cite this page

510(k) Report. “K022612: Ibond Gluma Inside.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022612

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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