Cleared Traditional

K231502 - Mini Screws (FDA 510(k) Clearance)

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

K231502 is an FDA 510(k) clearance for the Mini Screws. Classified as Implant, Endosseous, Orthodontic (product code OAT), Class II - Special Controls.

Submitted by Proimtech Saglik Urunleri Anonim Sirketi (Istanbul, TR). The FDA issued a Cleared decision on September 4, 2024 after a review of 469 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3640 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Proimtech Saglik Urunleri Anonim Sirketi devices

Submission Details

510(k) Number K231502 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
342d slower than avg
Panel avg: 127d · This submission: 469d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OAT Implant, Endosseous, Orthodontic
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - OAT Implant, Endosseous, Orthodontic

All 50
Devices cleared under the same product code (OAT) and FDA review panel - the closest regulatory comparables to K231502.
Leone Orthodontic Implant TAD (Temporary Anchorage Device)
K242944 · Leone S.P.A. · Jun 2025
T-FIT
K231913 · Techwin Co., Ltd. · Feb 2024
ACR Screw System
K222245 · Biomaterials Korea, Inc. · Aug 2023
Mico One Orthodontic Screw
K202163 · Ze Fang Technology Co., Ltd. · Oct 2022
Ortholock Anchorage Devices
K202691 · Craniofacial Technologies, Inc. · Apr 2022
ATOZ Mini-Screw
K210559 · Mk Meditech, Inc. · Dec 2021