Cleared Special

K111809 - SL TYPE ORTHODONTIC ANCHOR SCREWS, SPL TYPE ORTHODONTIC ANCHOR SCREWS

K111809 is an FDA 510(k) clearance for SL TYPE ORTHODONTIC ANCHOR SCREWS, manufactured by Biomaterials Korea, Inc.. The device is a Class 2 Dental device with product code OAT cleared through the Special 510(k) pathway after a 91-day FDA review.

K111809 · Biomaterials Korea, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2011
Decision
91d
Days
Class 2
Risk

K111809 is an FDA 510(k) clearance for the SL TYPE ORTHODONTIC ANCHOR SCREWS, SPL TYPE ORTHODONTIC ANCHOR SCREWS. Classified as Implant, Endosseous, Orthodontic (product code OAT), Class II - Special Controls.

Submitted by Biomaterials Korea, Inc. (Greenwood Village, US). The FDA issued a Cleared decision on September 26, 2011 after a review of 91 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. 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Biomaterials Korea, Inc. devices

FDA 510(k) Submission Details - K111809

510(k) Number K111809 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 2011
Decision Date September 26, 2011
Days to Decision 91 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
37d faster than avg
Panel avg: 128d · This submission: 91d
Pathway characteristics
Modification to existing cleared device.

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 50
Devices cleared under the same product code (OAT) and FDA review panel - the closest regulatory comparables to K111809.
FIN-S MICROIMPLANT
K120861 · Creekside Orthodontics · Feb 2013
ORTHOFIX SCREW
K113650 · Bonafix Surgical and Dental Implants, LLC · Oct 2012
PSM LOMAS / BENEFIT SCREWS
K110392 · Psm Medical Solutions · Dec 2011
ORTHO EASY PIN
K110275 · Forestadent Bernhard Forster GmbH · Jun 2011
ORTHODONTIC SCREW
K103105 · Osstem Implant Co., Ltd. · Mar 2011
NEODENT IMPLANT FOR ORTHODONTIC ANCHORAGE
K102769 · Jjgc Industria E Comercio DE Materiais Dentarios S · Feb 2011