Cleared Traditional

ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES

K180718 · Tomy, Inc. · Dental

Oct 2018

Decision

225d

Days

Class 2

Risk

About This 510(k) Submission

K180718 is an FDA 510(k) clearance for the ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES, a Bracket, Plastic, Orthodontic (Class II — Special Controls, product code DYW), submitted by Tomy, Inc. (Midori-Cho, Fuchu City, JP). The FDA issued a Cleared decision on October 30, 2018, 225 days after receiving the submission on March 19, 2018. This device falls under the Dental review panel. Regulated under 21 CFR 872.5470.

Submission Details

510(k) Number	K180718 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 19, 2018
Decision Date	October 30, 2018
Days to Decision	225 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF