Cleared Traditional

K130476 - ORTHODONTIC MINISCREW FOR ABSOLUTE ANCHORAGE

K130476 is an FDA 510(k) clearance for ORTHODONTIC MINISCREW FOR ABSOLUTE ANCH..., manufactured by Dental Morelli. The device is a Class 2 Dental device with product code OAT cleared through the Traditional 510(k) pathway after a 317-day FDA review.

K130476 · Dental Morelli · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2014
Decision
317d
Days
Class 2
Risk

K130476 is an FDA 510(k) clearance for the ORTHODONTIC MINISCREW FOR ABSOLUTE ANCHORAGE. Classified as Implant, Endosseous, Orthodontic (product code OAT), Class II - Special Controls.

Submitted by Dental Morelli (Aventura, US). The FDA issued a Cleared decision on January 8, 2014 after a review of 317 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Dental Morelli devices

FDA 510(k) Submission Details - K130476

510(k) Number K130476 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 2013
Decision Date January 08, 2014
Days to Decision 317 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
190d slower than avg
Panel avg: 127d · This submission: 317d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OAT Device Classification - Class 2, Special Controls

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 26
Devices cleared under the same product code (OAT) and FDA review panel - the closest regulatory comparables to K130476.
Anchor plate
K173623 · Biomaterials Korea, Inc. · Aug 2018
Dual Top Screw System
K161335 · Jeil Medical Corporation · Feb 2017
Orthodontic Screw
K161197 · Osstem Implant Co., Ltd. · Dec 2016
ORTHODONTIC SCREW
K103105 · Osstem Implant Co., Ltd. · Mar 2011
SYNTHES ORTHODONTIC BONE ANCHOR SYSTEM
K093299 · Synthes (Usa) · Dec 2010
SYNTHES ORTHODONTIC BONE ANCHOR SYSTEM
K063473 · Synthes (Usa) · Mar 2007