Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SINCLAIR ORAL RINSE

K-Number: K053166 · 2006-05-17

ApplicantSinclair Pharmaceuticals Limited
Decision Date2006-05-17
Product CodeNTO
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SINCLAIR ORAL RINSE is the device name listed in this FDA 510(k) record. The listed applicant is Sinclair Pharmaceuticals Limited. It received FDA 510(k) clearance on 2006-05-17 under 510(k) number K053166. The device is classified under product code NTO. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SINCLAIR ORAL RINSE?

SINCLAIR ORAL RINSE is a medical device that received FDA 510(k) clearance on 2006-05-17. The listed applicant is Sinclair Pharmaceuticals Limited. The 510(k) number is K053166.

When did SINCLAIR ORAL RINSE receive FDA 510(k) clearance?

SINCLAIR ORAL RINSE received FDA 510(k) clearance on 2006-05-17, under 510(k) number K053166.

Who is the listed applicant for SINCLAIR ORAL RINSE?

The FDA 510(k) record lists Sinclair Pharmaceuticals Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SINCLAIR ORAL RINSE?

The FDA product code for SINCLAIR ORAL RINSE is NTO.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑