Cleared Traditional

K061230 - VECTORS TEMPORARY ANCHORAGE SYSTEM

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

K061230 · Sybron Dental Specialties · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K061230

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 128d · This submission: 93d
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 51
Devices cleared under the same product code (OAT) and FDA review panel - the closest regulatory comparables to K061230.
TOMAS PIN SD 6, 8, AND 10 MM
K062733 · Dentaurum · Nov 2006
TOMAS PIN 6 MM
K062732 · Dentaurum · Oct 2006
ACE SURGICAL ORTHODONTIC BONE SCREW SYSTEMS, 1.2/1.5 MM X 6MM,8MM, MODEL 454-91001,454-91002 AND 1.2/1.5MM X 6,8,10MM, M
K061397 · Ace Surgical Supply Co., Inc. · Aug 2006
ORTHO ORGANIZERS TEMPORARY ORTHODONTIC ANCHOR
K061266 · Ortho Organizers, Inc. · Jul 2006
STRAUMANN ORTHOSYSTEM
K060062 · Institut Straumann AG · Feb 2006
TOMAS PIN
K042965 · Dentaurum, Inc. · Apr 2005
K061230 · VECTORS TEMPORARY ANCHORAGE SYSTEM
Download PDF FDA Summary Sybron Dental Special…