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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 a medical device manufactured by Ec Certification Service GmbH. It received FDA 510(k) clearance on 2025-04-21 under approval 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. It is manufactured by Ec Certification Service GmbH. The 510(k) number is K251196.

When was Composite Orthodontic Brackets and Buttons approved by the FDA?

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

What company makes Composite Orthodontic Brackets and Buttons?

Composite Orthodontic Brackets and Buttons is manufactured by Ec Certification Service GmbH.

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 Clinical Trials

NCT07318623 Comparative Outcomes of Damon Ultima vs Pitts 21 Pro Bracket Systems NOT_YET_RECRUITING NCT07261735 Clinical Evaluation of Customized Attachment Composites in Clear Aligner Therapy RECRUITING NCT07355400 Clinical Evaluation of the NeoPill Device for Reduction of Oral Bacterial Load in Patients With Fixed Orthodontic Appliances RECRUITING NCT07511296 Orthognathic Surgery With Clear Aligners vs Conventional Brackets COMPLETED NCT07503314 Comparison of Alignment Efficiency, Arch Dimensional Changes, and Passive Extraction Space Closure Between Self-Ligating and Conventional Brackets COMPLETED

Related Devices (Code: DYW)

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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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