Cleared Traditional

K191041 - Orthodontic Fixation Screw [Smart Anchor Miniscrew] (FDA 510(k) Clearance)

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

K191041 · Gni Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2020
Decision
497d
Days
Class 2
Risk

K191041 is an FDA 510(k) clearance for the Orthodontic Fixation Screw [Smart Anchor Miniscrew]. Classified as Implant, Endosseous, Orthodontic (product code OAT), Class II - Special Controls.

Submitted by Gni Co., Ltd. (Hwaseong, KR). The FDA issued a Cleared decision on August 28, 2020 after a review of 497 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 Gni Co., Ltd. devices

Submission Details

510(k) Number K191041 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 2019
Decision Date August 28, 2020
Days to Decision 497 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
370d slower than avg
Panel avg: 127d · This submission: 497d
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 K191041.
Leone Orthodontic Implant TAD (Temporary Anchorage Device)
K242944 · Leone S.P.A. · Jun 2025
Mini Screws
K231502 · Proimtech Saglik Urunleri Anonim Sirketi · Sep 2024
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