Cleared Special

Syntec Orthodontic Mini Screw Extended System (K202790) - FDA 510(k) Clearance

Class II Dental device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K202790 · Syntec Scientific Corporation · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2021
Decision
360d
Days
Class 2
Risk

K202790 is an FDA 510(k) clearance for the Syntec Orthodontic Mini Screw Extended System. Classified as Implant, Endosseous, Orthodontic (product code OAT), Class II - Special Controls.

Submitted by Syntec Scientific Corporation (Chang Hua, TW). The FDA issued a Cleared decision on September 17, 2021 after a review of 360 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Elevated predicate reliance profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Syntec Scientific Corporation devices

Submission Details

510(k) Number K202790 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 2020
Decision Date September 17, 2021
Days to Decision 360 days
Submission Type Special
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
233d slower than avg
Panel avg: 127d · This submission: 360d
Pathway characteristics
Modification to existing cleared device.

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 Consultant

Syntec Scientific Corporation - Taipei Office
Nicole Tseng

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - OAT Implant, Endosseous, Orthodontic

All 18
Devices cleared under the same product code (OAT) and FDA review panel - the closest regulatory comparables to K202790.
Ortholock Anchorage Devices
K202691 · Craniofacial Technologies, Inc. · Apr 2022
ATOZ Mini-Screw
K210559 · Mk Meditech, Inc. · Dec 2021
Ortho MI System
K211992 · Osteonic Co., Ltd. · Oct 2021
OBS Anchorage Screw, Biokey Anchorage Screw
K202278 · Bomei Co, Ltd. · Jan 2021
Blue Sky Bio TAD
K201919 · Blue Sky Bio, LLC · Dec 2020
Orthodontic Fixation Screw [Smart Anchor Miniscrew]
K191041 · Gni Co., Ltd. · Aug 2020