510(k) · Cleared

Cleared

Cervitec F

K191453510(k) TraditionalCleared Feb 11, 2020256-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

Ivoclar Vivadent, AG · LBH Varnish, Cavity

Cleared on Feb 11, 2020 as substantially equivalent to K131487 (Ivoclar Vivadent, AG, 2014) after a 256-day review. Its family tree reaches back 2 generations to 1995.

Decided: Feb 11, 2020
Review: 256 days
Class: Class II
Product code: LBH
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K946032 (1995). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK946032 Fluor ProtectorIvoclar North America, Inc. · 1995
1 generation backK131487 Fluor Protector SIvoclar Vivadent, AG · 2014
This deviceK191453 Cervitec FIvoclar Vivadent, AG · 2020

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K946032	Fluor Protector	Ivoclar North America, Inc.	1995	—
−1	K131487	Fluor Protector S	Ivoclar Vivadent, AG	2014	—
0 (this device)	K191453	Cervitec F	Ivoclar Vivadent, AG	2020	—

FIG. 1 — Lineage of K191453, 1995–2020Source: 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
*	K131487	Fluor Protector S Summary page 4 …y (872.3260) (Classification Code LBH) Device Class and panel: Class 2- dental Primary Predicate: Fluor Protector S (K131487) by Ivoclar Vivadent, AG Reference Device: Cervitec Plus (K072338) by Ivoclar Vivadent, AG Reference Device:…	Ivoclar Vivadent, AG	2014	—
†	K072338	Cervitec Plus	Ivoclar Vivadent, Inc.	2007	—
†	K103745	Biotene Moisturizing Mouth Spray for Dry Mouth Symptom Relief	Glaxosmithkline Consumer Healthcare (Gskch)	2011	—

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 25 years and passes through 2 companies; a new generation was cleared every 19.6 years on median.
None of the 2 ancestors has a recall.

How does its category compare?

All LBH devices

LBH Varnish, Cavity: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?

For treatment of dentinal hypersensitivity secondary to exposed dentin and root cervical surfaces.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K191453 · printed Nov 6, 2026

Cite this page

510(k) Report. “K191453: Cervitec F.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191453

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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