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FDA 510(k)

Composite Orthodontic Brackets and Buttons

K-Number: K251196 · 2025-04-21

ApplicantEc Certification Service GmbH
Decision Date2025-04-21
Product CodeDYW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Composite Orthodontic Brackets and Buttons is the device name listed in this FDA 510(k) record. The listed applicant is Ec Certification Service GmbH. It received FDA 510(k) clearance on 2025-04-21 under 510(k) number K251196. The device is classified under product code DYW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Composite Orthodontic Brackets and Buttons?

Composite Orthodontic Brackets and Buttons is a medical device that received FDA 510(k) clearance on 2025-04-21. The listed applicant is Ec Certification Service GmbH. The 510(k) number is K251196.

When did Composite Orthodontic Brackets and Buttons receive FDA 510(k) clearance?

Composite Orthodontic Brackets and Buttons received FDA 510(k) clearance on 2025-04-21, under 510(k) number K251196.

Who is the listed applicant for Composite Orthodontic Brackets and Buttons?

The FDA 510(k) record lists Ec Certification Service GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Composite Orthodontic Brackets and Buttons?

The FDA product code for Composite Orthodontic Brackets and Buttons is DYW.

Related Devices (Code: DYW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252760Carriere® Motion Pro® Clear Bite CorrectorOrtho Organizers, Inc.K201940Braces on Demand BracketBraces on Demand, Inc.K182338Blue Sky Bio Computerized Orthodontic Bracket SystemBlue Sky BioK180718ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIESTomy, Inc.K160720Carriere Motion Clear Class IIOrtho Organizers, Inc.K150830CompleClear Plastic Orthodontic Bracket and Wire ApplianceOracrew

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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