510(k) · Cleared

Cleared

Gluma Desensitizer Power Gel

K093575510(k) TraditionalCleared Mar 5, 2010107-day reviewClass II21 CFR 872.3260

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

Heraeus Kulzer, LLC · LBH Varnish, Cavity

Cleared on Mar 5, 2010 as substantially equivalent to K962812 (Heraeus Kulzer, Inc., 1996) after a 107-day review. Its family tree reaches back 1 generation to 1996.

Decided: Mar 5, 2010
Review: 107 days
Class: Class II
Product code: LBH
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K962812 (1996). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK962812 Gluma Desensitizer/Gluma 3 PrimerHeraeus Kulzer, Inc. · 1996
This deviceK093575 Gluma Desensitizer Power GelHeraeus Kulzer, LLC · 2010

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K962812	Gluma Desensitizer/Gluma 3 Primer	Heraeus Kulzer, Inc.	1996	—
0 (this device)	K093575	Gluma Desensitizer Power Gel	Heraeus Kulzer, LLC	2010	—

FIG. 1 — Lineage of K093575, 1996–2010Source: 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 LBH? 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 LBH device

#1 K262243 Profisil Freescore 12.8 · 4 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (1)

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
*	K962812	Gluma Desensitizer/Gluma 3 Primer Summary page 1 …Is Kiebemittel. 3. Substantially equivalence Gluma Desensitizer PowerGel (Project Name IGLU) is a revised version of the product Gluma Desensitizer (K96281 2). The main components and their ratio InIGLU and Gluma Desensitizer are similar. IGLU contains additionally filler…	Heraeus Kulzer, Inc.	1996	—

Also cleared against K962812: 2 other devices →

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?

Its one ancestor has no recall.
2 other devices also cite its predicate K962812.

How does its category compare?

All LBH devices

LBH Varnish, Cavity: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · LBH

4in 2025

2007high 8 (2007) · low 0 (2017)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LBH

223in 2025

2007high 256 (2020) · low 69 (2007)2026

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

Recalls per year · LBH

1in 2019

2007high 3 (2014) · low 0 (2007)2026

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

Adverse event reports per year · LBH

7in 2025

2007high 40 (2014) · low 3 (2008)2025

MAUDE reports naming product code LBH, 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	8	69	0	4
2008	6	79	0	3
2009	4	69	0	5
2010	7	107	0	7
2011	3	72	0	8
2012	4	83	0	7
2013	6	160	0	27
2014	6	204	3	40
2015	2	—	0	14
2016	2	—	0	12
2017	0	—	0	11
2018	0	—	2	13
2019	2	—	1	9
2020	5	256	0	10
2021	0	—	0	15
2022	1	—	0	7
2023	3	167	0	8
2024	3	237	0	6
2025	4	223	0	7
2026	5	64	0	—

What is it indicated for?

Reduction or even elimination of pain in exposed cervical areas that do not require restoration.

Alleviation or reduction of dentine sensitivity after preparation of teeth to receive fixed prosthesis or restorations.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K093575 · printed Nov 6, 2026

Cite this page

510(k) Report. “K093575: Gluma Desensitizer Power Gel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093575

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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