Braces on Demand Bracket— 510(k) K201940

Name: FDA 510(k) clearance K201940
Creator: U.S. Food and Drug Administration
Published: 2020-12-03

Substantially Equivalent

Braces on Demand, Inc.

FDA 510(k) clearance K201940 for Braces on Demand Bracket, Substantially Equivalent on 2020-12-03. Applicant: Braces on Demand, Inc.. Device class: 2.

Clearance details

Applicant: Braces on Demand, Inc.
Product code: Code DYW
Device class: Class 2
Regulation: 21 CFR 872.5470
Advisory panel: Dental
Date received: 2020-07-13
Decision date: 2020-12-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hicksville, NY, US

Download summary PDF View on FDA.gov ↗

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