510(k) · Cleared

Cleared

PCXX Varnish

K113146510(k) AbbreviatedCleared Jan 23, 201291-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

Ross Healthcare, Inc. · LBH Varnish, Cavity

Cleared on Jan 23, 2012 as substantially equivalent to K961893 (Pharmascience, Inc., 1996) and 2 other predicates after a 91-day review. Its family tree reaches back 2 generations to 1995.

Decided: Jan 23, 2012
Review: 91 days
Class: Class II
Product code: LBH
Recalls: None
Predicates: 3

Its longest line of descent runs back 2 generations to K945794 (1995). 4 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK945794 DuraphatInpharma · 1995
1 generation backK030488 FluorilaqPascal Co., Inc. · 2003
This deviceK113146 PCXX VarnishRoss Healthcare, Inc. · 2012

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K945794	Duraphat	Inpharma	1995	—
−1	K030488	Fluorilaq	Pascal Co., Inc.	2003	—
0 (this device)	K113146	PCXX Varnish	Ross Healthcare, Inc.	2012	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0
1999	1	0

FIG. 1 — Lineage of K113146, 1995–2012Source: 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 12.9 · 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? (3)

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
*	K961893	Duraflor Summary page 1 …872.3260) 3. Predicated Devices Device Conany K umber IDuraflor IPharmascience, Inc IK961893 Duraphat Colgate K945 794 Fluorilaq Pascal Co., Inc.…	Pharmascience, Inc.	1996	—
*	K945794	Duraphat Summary page 1 …Conany K umber IDuraflor IPharmascience, Inc IK961893 Duraphat Colgate K945 794 Fluorilaq Pascal Co., Inc. K030488 4.&5. Description and Intended Use PCxx Varnish i…	Inpharma	1995	—
*	K030488	Fluorilaq Summary page 1 …IPharmascience, Inc IK961893 Duraphat Colgate K945 794 Fluorilaq Pascal Co., Inc. K030488 4.&5. Description and Intended Use PCxx Varnish is 5%Sodium Fluoride Varnish that reduces tooth sensitivity by…	Pascal Co., Inc.	2003	—

Also cleared against K961893: 4 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?

The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 8.7 years on median.
None of the 4 ancestors has a recall.
4 other devices also cite its predicate K961893.

How does its category compare?

All LBH devices

LBH Varnish, Cavity: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?

Treatment of hypersensitive teeth

Use on exposed dentin and root sensitivity

Under temporary restoratives and cements where post-operative sensitivity is of concern.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K113146 · printed Nov 3, 2026

Cite this page

510(k) Report. “K113146: PCXX Varnish.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K113146

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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