510(k) Report

510(k) · Cleared

Cleared

Sinclair Oral Rinse

K053166510(k) TraditionalCleared May 17, 2006184-day reviewClass II21 CFR 872.5580

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

Sinclair Pharmaceuticals Limited · NTO Rinse, Oral, Antibacterial (By Physical Means)

Cleared on May 17, 2006 as substantially equivalent to DEN050001 (Sinclair Pharmaceuticals Limited, 2005) after a 184-day review. Its family tree reaches back 1 generation to 2005.

Decided
May 17, 2006
Review
184 days
Class
Class II
Product code
NTO
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to DEN050001 (2005). No later device cites it as a predicate yet.

DEN050001 · Decapinol Oral Rinse · Sinclair Pharmaceuticals Limited · 200520062008
DEN050001 · Decapinol Oral Rinse · Sinclair Pharmaceuticals Limited · 20050
  1. Root · 1 generation backDEN050001 Decapinol Oral RinseSinclair Pharmaceuticals Limited · 2005
  2. This deviceK053166 Sinclair Oral RinseSinclair Pharmaceuticals Limited · 2006
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1DEN050001Decapinol Oral RinseSinclair Pharmaceuticals Limited2005—
0 (this device)K053166Sinclair Oral RinseSinclair Pharmaceuticals Limited2006—
FIG. 1 — Lineage of K053166, 2005–2006Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 NTO? 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*DEN050001Decapinol Oral Rinse
Our reading of the summary gave K041482, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN050001, Decapinol Oral Rinse (Sinclair Pharmaceuticals Limited), granted Apr 18, 2005; older De Novo requests were first filed under a 510(k) number, so this links to the grant.
Sinclair Pharmaceuticals Limited2005—

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?

  • Its one ancestor has no recall.

How does its category compare?

All NTO devices

NTO Rinse, Oral, Antibacterial (By Physical Means): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · NTO

FDA has decided no NTO device since 2007.

Median 510(k) review, days · NTO

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

Recalls per year · NTO

1in 2023

2023: 1
2007high 1 (2023) · low 0 (2007)2026

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

Adverse event reports per year · NTO

1in 2025

2012: 12015: 22016: 12020: 12021: 232025: 1
2007high 23 (2021) · low 0 (2007)2025

MAUDE reports naming product code NTO, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—01
20130—00
20140—00
20150—02
20160—01
20170—00
20180—00
20190—00
20200—01
20210—023
20220—00
20230—10
20240—00
20250—01
20260—0—

What is it indicated for?

SINCLAIR ORAL RINSE helps to prevent and reduce

gingivitis, when used as directed.

SINCLAIR ORAL RINSE serves as an adjunct to normal

mechanical oral hygiene where this has proved inadequate.

Indications for use as stated in the FDA summary.

More from Sinclair Pharmaceuticals Limited

2 FDA decisions under this applicant name. See the company

  • DEN050001Decapinol Oral RinseSinclair Pharmaceuticals Limited · 2005

Recent decisions in NTO

The NTO category page

  • DEN050001Decapinol Oral RinseSinclair Pharmaceuticals Limited · 2005

https://510kreport.com/device/K053166 · printed Nov 6, 2026

Cite this page

510(k) Report. “K053166: Sinclair Oral Rinse.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053166

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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