510(k) · Cleared

Cleared

Duraphat

K945794510(k) TraditionalCleared Jul 26, 1995243-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

Inpharma · LBH Varnish, Cavity

Cleared on Jul 26, 1995 after a 243-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 11 later devices descend from it.

Decided: Jul 26, 1995
Review: 243 days
Class: Class II
Product code: LBH
Recalls: None
Predicates: 0

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

This deviceK945794 DuraphatInpharma · 1995
Descendant · cites it directly · 2 of its ownK031932 Fluoride VarnishDentsply Intl. · 2003
Descendant · cites it directly · 2 of its ownK030488 FluorilaqPascal Co., Inc. · 2003
Descendant · cites it directly · 1 of its ownK131376 Smartcoat 2.5% Naf VarnishElevate Oral Care · 2013
Descendant · cites it directly · 1 of its ownK112946 Activ VarnishPulpdent Corporation · 2011
Descendant · 2 generations on · 0 of its ownK250714 FluoroDose VarnishCentrix, Inc. · 2025

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2003high 2 (2003) · low 0 (2004)2026

Most influential descendants

Showing 5 of 11 · See all

K031932Fluoride VarnishDentsply Intl. · 2003 · cites it directly2descendants
K030488FluorilaqPascal Co., Inc. · 2003 · cites it directly2descendants
K131376Smartcoat 2.5% Naf VarnishElevate Oral Care · 2013 · cites it directly1descendant
K112946Activ VarnishPulpdent Corporation · 2011 · cites it directly1descendant
K250714FluoroDose VarnishCentrix, Inc. · 2025 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K945794	Duraphat	Inpharma	1995	—
+1	K031932	Fluoride Varnish	Dentsply Intl.	2003	—
+1	K030488	Fluorilaq	Pascal Co., Inc.	2003	—
+1	K131376	Smartcoat 2.5% Naf Varnish	Elevate Oral Care	2013	—
+1	K112946	Activ Varnish	Pulpdent Corporation	2011	—
+2	K250714	FluoroDose Varnish	Centrix, Inc.	2025	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	2	0
2008	1	0
2009	1	0
2010	1	0
2011	1	0
2012	2	0
2013	1	0
2015	1	0
2025	1	0

FIG. 1 — Lineage of K945794, 1995–2025Source: 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 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

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? (11)

See all 11

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

Number	Device	Applicant	Decided	Descendants
K031932	Fluoride Varnish	Dentsply Intl.	2003	2
K030488	Fluorilaq	Pascal Co., Inc.	2003	2
K131376	Smartcoat 2.5% Naf Varnish	Elevate Oral Care	2013	1
K112946	Activ Varnish	Pulpdent Corporation	2011	1
K151302	Clinpro Varnish	3M Company	2015	0
K113146	PCXX Varnish	Ross Healthcare, Inc.	2012	0
K100503	Pulpdent Copal Varnish with Fluoride	Pulpdent Corporation	2010	0
K080814	Voco Profluorid Varnish	Voco GmbH	2008	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, K031932 (Dentsply Intl., 2003) has gone furthest, with 2 descendants of its own.

How does its category compare?

All LBH devices

LBH Varnish, Cavity: FDA decisions, review times, recalls and adverse event reports over 20 years.

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	—

https://510kreport.com/device/K945794 · printed Nov 6, 2026

Cite this page

510(k) Report. “K945794: Duraphat.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K945794

Report an extraction error

Are you the manufacturer?

Record history

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