Braces on Demand Bracket

FDA 510(k) K201940 · Braces on Demand, Inc.

Substantially Equivalent

510(k) numberK201940

Submission

Device name
Braces on Demand Bracket
Applicant
Braces on Demand, Inc.
Hicksville, NY, US
Received
July 13, 2020
Decision date
December 3, 2020
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DYW – Bracket, Plastic, Orthodontic
Device class
Class II (moderate risk)
Regulation
21 CFR 872.5470
Specialty
Dental

Other 510(k)s with product code DYW

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K252760Carriere® Motion Pro® Clear Bite CorrectorDYW · Traditional Ortho Organizers, Inc.11/27/2025SE
K251196Composite Orthodontic Brackets and ButtonsDYW · Traditional Ec Certification Service GmbH04/21/2025SE
K182338Blue Sky Bio Computerized Orthodontic Bracket SystemDYW · Traditional Blue Sky Bio11/09/2018SE
K180718Orthodontic Plastic Brackets and AccessoriesDYW · Traditional Tomy, Inc.10/30/2018SE
K160720Carriere Motion Clear Class IIDYW · Traditional Ortho Organizers, Inc.11/28/2016SE
K150830CompleClear Plastic Orthodontic Bracket and Wire ApplianceDYW · Traditional Oracrew08/26/2016SE
K150702Exceed TxDYW · Traditional Great Lakes Orthodontics, Ltd.03/24/2016SE
K140807Composite Orthodontic BracketsDYW · Traditional Ortho Specialties11/12/2014SE
K123118Insignia DigicastDYW · Traditional Ormco Corp.03/26/2013SE
K123416Insignia with IteroDYW · Traditional Ormco Corp.03/13/2013SE

Questions and answers

When was Braces on Demand Bracket cleared by the FDA?

Braces on Demand Bracket (K201940) received a 510(k) decision of Substantially Equivalent on December 3, 2020, 143 days after the submission was received.

What is the product code of K201940?

The FDA product code is DYW – Bracket, Plastic, Orthodontic, a Class II (moderate risk) device regulated under 21 CFR 872.5470.