Cleared Traditional

BUTLER ANTIBACTERIAL INTERDENTAL TOOTHBRUSH

K974761 · John O. Butler Co. · Dental

Jun 1998

Decision

179d

Days

Class 1

Risk

About This 510(k) Submission

K974761 is an FDA 510(k) clearance for the BUTLER ANTIBACTERIAL INTERDENTAL TOOTHBRUSH, a Toothbrush, Manual (Class I — General Controls, product code EFW), submitted by John O. Butler Co. (Chicago, US). The FDA issued a Cleared decision on June 16, 1998, 179 days after receiving the submission on December 19, 1997. This device falls under the Dental review panel. Regulated under 21 CFR 872.6855.

Submission Details

510(k) Number	K974761 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 19, 1997
Decision Date	June 16, 1998
Days to Decision	179 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement