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BIOTENE ORAL BALANCE GEL, BIOTENE DRY MOUTH ORAL RINSE, BIOTENE MOISTURIZING MOUTH SPRAY

K123731 Special
Decision Date
2013-01-04
Sponsor / Applicant
Glaxosmithkline Consumer Healthcare (Gskch)

Technical Specification

510(k) Submission ID K123731
Product Code LFD
Medical Specialty / Panel Unknown
Decision Date 2013-01-04
Clearance Pathway Special

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

BIOTENE ORAL BALANCE GEL, BIOTENE DRY MOUTH ORAL RINSE, BIOTENE MOISTURIZING MOUTH SPRAY received FDA 510(k) clearance under submission number K123731, sponsored by Glaxosmithkline Consumer Healthcare (Gskch). The device was reviewed via the Special premarket notification pathway and assigned to the Unknown review panel. The statutory decision date of record is 2013-01-04.

Classification & Regulation

This clearance is catalogued under FDA product code LFD , within the Unknown review panel as a device.