Cleared Traditional

Mini Screws

K231502 · Proimtech Saglik Urunleri Anonim Sirketi · Dental
Sep 2024
Decision
469d
Days
Class 2
Risk

About This 510(k) Submission

K231502 is an FDA 510(k) clearance for the Mini Screws, a Implant, Endosseous, Orthodontic (Class II — Special Controls, product code OAT), submitted by Proimtech Saglik Urunleri Anonim Sirketi (Istanbul, TR). The FDA issued a Cleared decision on September 4, 2024, 469 days after receiving the submission on May 24, 2023. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number K231502 FDA.gov
FDA Decision Cleared SESE
Date Received May 24, 2023
Decision Date September 04, 2024
Days to Decision 469 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code OAT — Implant, Endosseous, Orthodontic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3640
Definition It Is Intended To Provide A Fixed Anchorage Point For Attachment Of Orthodontic Appliances To Facilitate The Orthodontic Movement Of Teeth. It Is Used Temporarily And Is Removed After Orthodontic Treatment Has Been Completed.