Cleared Traditional

Braces on Demand Bracket

K201940 · Braces on Demand, Inc. · Dental

Dec 2020

Decision

143d

Days

Class 2

Risk

About This 510(k) Submission

K201940 is an FDA 510(k) clearance for the Braces on Demand Bracket, a Bracket, Plastic, Orthodontic (Class II — Special Controls, product code DYW), submitted by Braces on Demand, Inc. (Hicksville, US). The FDA issued a Cleared decision on December 3, 2020, 143 days after receiving the submission on July 13, 2020. This device falls under the Dental review panel. Regulated under 21 CFR 872.5470.

Submission Details

510(k) Number	K201940 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 13, 2020
Decision Date	December 03, 2020
Days to Decision	143 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF