510(k) · Cleared

Cleared

Senzzzzz Away

K120176510(k) TraditionalCleared Jul 25, 2012187-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

Cleared on Jul 25, 2012 as substantially equivalent to K021146 (Centrix, Inc., 2002) and 7 other predicates after a 187-day review. Its family tree reaches back 3 generations to 2000. 2 later devices descend from it.

Decided: Jul 25, 2012
Review: 187 days
Class: Class II
Product code: LBH
Recalls: None
Predicates: 8

Its longest line of descent runs back 3 generations to K002989 (2000). 14 ancestors in all, the oldest K931096 (1993). 2 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 3 generations backK002989 ProcludeOrtek Therapeutics, Inc. · 2000
2 generations backK024343 Butler Gum Prophy Paste with NovaminUsbiomaterials Corp. · 2003
1 generation backK040858 Oralief Therapy for Sensitive TeethNovamin Technology, Inc. · 2004
This deviceK120176 Senzzzzz AwayCentrix, Inc. · 2012
Descendant · cites it directly · 1 of its ownK122708 Remesense for Sensitive TeethSylphar N.V. · 2013
Descendant · 2 generations on · 0 of its ownK132426 Sylphar Remesense Sensitivity Relief StripsSylphar N.V. · 2014

Most influential descendants

Showing 2 of 2 · See all

K122708Remesense for Sensitive TeethSylphar N.V. · 2013 · cites it directly1descendant
K132426Sylphar Remesense Sensitivity Relief StripsSylphar N.V. · 2014 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K002989	Proclude	Ortek Therapeutics, Inc.	2000	—
−2	K024343	Butler Gum Prophy Paste with Novamin	Usbiomaterials Corp.	2003	—
−1	K040858	Oralief Therapy for Sensitive Teeth	Novamin Technology, Inc.	2004	—
0 (this device)	K120176	Senzzzzz Away	Centrix, Inc.	2012	—
+1	K122708	Remesense for Sensitive Teeth	Sylphar N.V.	2013	—
+2	K132426	Sylphar Remesense Sensitivity Relief Strips	Sylphar N.V.	2014	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1993	1	0
1998	1	0
2002	1	0
2003	1	0
2004	2	0
2005	1	0
2007	1	0
2008	1	0
2009	1	0
2012	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2013	1	0
2014	1	0

FIG. 1 — Lineage of K120176, 2000–2014Source: 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? (8)

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
*	K021146	D/Sense 1-Step Summary page 2 …nsitivity 10 cold, hot and sweets. Senzzzzz Away is a one-part, opaque gel for single usc. EQUIVALENCE TO MARKETED DEVICE Centrix, Inc., D/Sense® 1-Step cleared under K021 146, Phoenix Dental, Inc., Super Seal® Tooth Desensitizer cleared under K983477 and K120109 Sunstar Butler, Protect™ Tooth Desensiti…	Centrix, Inc.	2002	—
*	K983477	Super Seal Summary page 2 …r single usc. EQUIVALENCE TO MARKETED DEVICE Centrix, Inc., D/Sense® 1-Step cleared under K021 146, Phoenix Dental, Inc., Super Seal® Tooth Desensitizer cleared under K983477 and K120109 Sunstar Butler, Protect™ Tooth Desensitizer cleared under K050486 NovaMin Technology, Inc., Oralief™ Therapy for Sens…	Phoenix Dental, Inc.	1998	—
*	K120109	Super Seal Tooth Desensitizer Cleared while this submission was under review Summary page 2 …. EQUIVALENCE TO MARKETED DEVICE Centrix, Inc., D/Sense® 1-Step cleared under K021 146, Phoenix Dental, Inc., Super Seal® Tooth Desensitizer cleared under K983477 and K120109 Sunstar Butler, Protect™ Tooth Desensitizer cleared under K050486 NovaMin Technology, Inc., Oralief™ Therapy for Sensitive Teeth…	Phoenix Dental, Inc.	2012	—
*	K050486	Protect Tooth Desensitizer Summary page 2 …cleared under K021 146, Phoenix Dental, Inc., Super Seal® Tooth Desensitizer cleared under K983477 and K120109 Sunstar Butler, Protect™ Tooth Desensitizer cleared under K050486 NovaMin Technology, Inc., Oralief™ Therapy for Sensitive Teeth cleared under K040858 Remedent NV, Remesense cleared under K082594…	Sunstar Butler	2005	—
*	K040858	Oralief Therapy for Sensitive Teeth Summary page 2 …under K983477 and K120109 Sunstar Butler, Protect™ Tooth Desensitizer cleared under K050486 NovaMin Technology, Inc., Oralief™ Therapy for Sensitive Teeth cleared under K040858 Remedent NV, Remesense cleared under K082594 Bisco, Inc., BisBlock cleared under K033521 Ultradent Products, Inc., UltraEZ Desen…	Novamin Technology, Inc.	2004	—
*	K082594	Remesense Summary page 2 …otect™ Tooth Desensitizer cleared under K050486 NovaMin Technology, Inc., Oralief™ Therapy for Sensitive Teeth cleared under K040858 Remedent NV, Remesense cleared under K082594 Bisco, Inc., BisBlock cleared under K033521 Ultradent Products, Inc., UltraEZ Desensitizing Gel cleared under K061438 Compariso…	Remedent NV	2009	—
*	K033521	Bisblock Summary page 2 …486 NovaMin Technology, Inc., Oralief™ Therapy for Sensitive Teeth cleared under K040858 Remedent NV, Remesense cleared under K082594 Bisco, Inc., BisBlock cleared under K033521 Ultradent Products, Inc., UltraEZ Desensitizing Gel cleared under K061438 Comparison of Technological Characteristics Device N…	Bisco, Inc.	2004	—
*	K061438	Ultraez Desensitizing Gel Summary page 2 …under K040858 Remedent NV, Remesense cleared under K082594 Bisco, Inc., BisBlock cleared under K033521 Ultradent Products, Inc., UltraEZ Desensitizing Gel cleared under K061438 Comparison of Technological Characteristics Device Name Classification Name Mode of Action { Application Material Senzzzzz Awa…	Ultradent Products, Inc.	2007	—

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
K122708	Remesense for Sensitive Teeth	Sylphar N.V.	2013	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?

The line of descent spans 12 years and passes through 4 companies; a new generation was cleared every 2.6 years on median.
None of the 14 ancestors has a recall.
Of its descendants, K122708 (Sylphar N.V., 2013) has gone furthest, with 1 descendant 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. 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?

To relieve dental hypersensitivity.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K120176 · printed Nov 4, 2026

Cite this page

510(k) Report. “K120176: Senzzzzz Away.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120176

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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