510(k) · Cleared

Cleared

Soothe-N-Seal Canker Sore Relief

K991923510(k) TraditionalCleared Sep 2, 199987-day reviewClass II21 CFR 872.3275

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

Closure Medical Corp. · MZW Dental Cement W/Out Zinc-Oxide Eugenol As An Ulcer Covering For Pain Relief

Cleared on Sep 2, 1999 as substantially equivalent to K902078 (Crx Medical, Inc., 1990) and 3 other predicates after an 87-day review. Its family tree reaches back 1 generation to 1990.

Decided: Sep 2, 1999
Review: 87 days
Class: Class II
Product code: MZW
Recalls: None
Predicates: 4

Its longest line of descent runs back 1 generation to K902078 (1990). 4 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK902078 Add'l Indication for Octyldent 2-Octyl Cranoacry.Crx Medical, Inc. · 1990
This deviceK991923 Soothe-N-Seal Canker Sore ReliefClosure Medical Corp. · 1999

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K902078	Add'l Indication for Octyldent 2-Octyl Cranoacry.	Crx Medical, Inc.	1990	—
0 (this device)	K991923	Soothe-N-Seal Canker Sore Relief	Closure Medical Corp.	1999	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	1	0
1997	1	0
1998	1	0

FIG. 1 — Lineage of K991923, 1990–1999Source: 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 MZW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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What was it cleared against? (4)

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
*	K902078	Add'l Indication for Octyldent 2-Octyl Cranoacry. Summary page 1 …ce Name Trade Name: SOOTHE-N-SEAL™ Canker Sore Relief Common Name: Liquid Protectant for Canker Sore Pain Relief Classification Name: unclassified Predicate Devices: K902078, K980159 Octyldent® Dental Adhesive K933741, K964852 Carrington® OraPatch™ 2. Device Description SOOTHE-N-SEAL™ Canker Sore Rel…	Crx Medical, Inc.	1990	—
*	K980159	Octyldent (2-Octyl Cyanoacrylate), 02A01 Summary page 1 …Trade Name: SOOTHE-N-SEAL™ Canker Sore Relief Common Name: Liquid Protectant for Canker Sore Pain Relief Classification Name: unclassified Predicate Devices: K902078, K980159 Octyldent® Dental Adhesive K933741, K964852 Carrington® OraPatch™ 2. Device Description SOOTHE-N-SEAL™ Canker Sore Relief (form…	Closure Medical Corp.	1998	—
*	K933741	Carrasyn Oral Wound Dressing Summary page 1 …ore Relief Common Name: Liquid Protectant for Canker Sore Pain Relief Classification Name: unclassified Predicate Devices: K902078, K980159 Octyldent® Dental Adhesive K933741, K964852 Carrington® OraPatch™ 2. Device Description SOOTHE-N-SEAL™ Canker Sore Relief (formulated 2-octyl cyanoacrylate) is a…	Carrington Laboratories, Inc.	1994	—
*	K964852	Radiacare Oral Wound Rinse Summary page 1 …f Common Name: Liquid Protectant for Canker Sore Pain Relief Classification Name: unclassified Predicate Devices: K902078, K980159 Octyldent® Dental Adhesive K933741, K964852 Carrington® OraPatch™ 2. Device Description SOOTHE-N-SEAL™ Canker Sore Relief (formulated 2-octyl cyanoacrylate) is a non-steri…	Carrington Laboratories, Inc.	1997	—

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?

None of the 4 ancestors has a recall.

How does its category compare?

All MZW devices

MZW Dental Cement W/Out Zinc-Oxide Eugenol As An Ulcer Covering For Pain Relief: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MZW

1in 2008

2007high 1 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MZW

Too few MZW 510(k)s in any year since 2007 to give a median.

Recalls per year · MZW

1in 2013

2007high 1 (2011) · low 0 (2007)2026

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

Adverse event reports per year · MZW

1in 2015

2007high 13 (2014) · low 0 (2007)2025

MAUDE reports naming product code MZW, 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	0	—	0	0
2008	1	—	0	0
2009	0	—	0	0
2010	0	—	0	0
2011	0	—	1	0
2012	0	—	0	0
2013	0	—	1	0
2014	0	—	0	13
2015	0	—	0	1
2016	0	—	0	0
2017	0	—	0	0
2018	0	—	0	0
2019	0	—	0	0
2020	0	—	0	0
2021	0	—	0	0
2022	0	—	0	0
2023	0	—	0	0
2024	0	—	0	0
2025	0	—	0	0
2026	0	—	0	—

What is it indicated for?

SOOTHE-N-SEAL™ Canker Sore Relief creates a thin, protective barrier that provides relief of pain associated with canker sores, mouth sores, and traumatic ulcers, such as those caused by braces.

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/K991923 · printed Nov 6, 2026

Cite this page

510(k) Report. “K991923: Soothe-N-Seal Canker Sore Relief.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991923

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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