meddevicedb.com FDA Device Reference

DECAPINOL ORAL RINSE

DEN050001 Class II Post-NSE
Decision Date
2005-04-18
Sponsor / Applicant
Sinclair Pharmaceuticals Limited

Technical Specification

510(k) Submission ID DEN050001
Product Code NTO
Medical Specialty / Panel Dental
Regulation Citation 21 CFR 872.5580
Decision Date 2005-04-18
Clearance Pathway Post-NSE

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

DECAPINOL ORAL RINSE received FDA 510(k) clearance under submission number DEN050001, sponsored by Sinclair Pharmaceuticals Limited. The device was reviewed via the Post-NSE premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2005-04-18.

Classification & Regulation

This clearance is catalogued under FDA product code NTO and 21 CFR 872.5580, within the Dental review panel as a Class II device.