Cleared Traditional

K061230 - VECTORS TEMPORARY ANCHORAGE SYSTEM

K061230 is the FDA 510(k) clearance for VECTORS TEMPORARY ANCHORAGE SYSTEM by Sybron Dental Specialties. It is a Class 2 Dental device (product code OAT) cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K061230 · Sybron Dental Specialties · Dental device
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Aug 2006
Decision
93d
Days
Class 2
Risk

K061230 is an FDA 510(k) clearance for the VECTORS TEMPORARY ANCHORAGE SYSTEM. Classified as Implant, Endosseous, Orthodontic (product code OAT), Class II - Special Controls.

Submitted by Sybron Dental Specialties (Newport Beach, US). The FDA issued a Cleared decision on August 3, 2006 after a review of 93 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 Sybron Dental Specialties devices

Submission Details

510(k) Number K061230 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 2006
Decision Date August 03, 2006
Days to Decision 93 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
34d faster than avg
Panel avg: 127d · This submission: 93d
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 25
Devices cleared under the same product code (OAT) and FDA review panel - the closest regulatory comparables to K061230.
SYNTHES ORTHODONTIC BONE ANCHOR SYSTEM
K093299 · Synthes (Usa) · Dec 2010
SYNTHES ORTHODONTIC BONE ANCHOR SYSTEM
K063473 · Synthes (Usa) · Mar 2007
LORENZ ORTHODONTIC ANCHORAGE SYSTEM
K063386 · Walter Lorenz Surgical, Inc. · Feb 2007
STRAUMANN ORTHOSYSTEM
K060062 · Institut Straumann AG · Feb 2006
ORTHO IMPLANT AND ACCESSORIES
K982509 · Straumann USA · Sep 1998