Cleared Traditional

FLOSSBRUSH WITH FLUORIDE

K964976 · Flossbrush Interdental Cleaner and Applicator · Dental

May 1997

Decision

145d

Days

Class 1

Risk

About This 510(k) Submission

K964976 is an FDA 510(k) clearance for the FLOSSBRUSH WITH FLUORIDE, a Floss, Dental (Class I — General Controls, product code JES), submitted by Flossbrush Interdental Cleaner and Applicator (San Francisco, US). The FDA issued a Cleared decision on May 6, 1997, 145 days after receiving the submission on December 12, 1996. This device falls under the Dental review panel. Regulated under 21 CFR 872.6390.

Submission Details

510(k) Number	K964976 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 12, 1996
Decision Date	May 06, 1997
Days to Decision	145 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement