Composite Orthodontic Brackets and Buttons— 510(k) K251196

Name: FDA 510(k) clearance K251196
Creator: U.S. Food and Drug Administration
Published: 2025-04-21

Substantially Equivalent

Ec Certification Service GmbH

FDA 510(k) clearance K251196 for Composite Orthodontic Brackets and Buttons, Substantially Equivalent on 2025-04-21. Applicant: Ec Certification Service GmbH. Device class: 2.

Clearance details

Applicant: Ec Certification Service GmbH
Product code: Code DYW
Device class: Class 2
Regulation: 21 CFR 872.5470
Advisory panel: Dental
Date received: 2025-04-17
Decision date: 2025-04-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sankt Veit An Der Glan, AT

Download summary PDF View on FDA.gov ↗

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K182338 — Blue Sky Bio Computerized Orthodontic Bracket System2018-11-09
K180718 — ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES2018-10-30
K160720 — Carriere Motion Clear Class II2016-11-28

Data sourced from openFDA. This site is unofficial and independent of the FDA.