Cleared Traditional

K110275 - ORTHO EASY PIN

K110275 is the FDA 510(k) clearance for ORTHO EASY PIN by Forestadent Bernhard Forster GmbH. It is a Class 2 Dental device (product code OAT) cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K110275 · Forestadent Bernhard Forster GmbH · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2011
Decision
123d
Days
Class 2
Risk

K110275 is an FDA 510(k) clearance for the ORTHO EASY PIN. Classified as Implant, Endosseous, Orthodontic (product code OAT), Class II - Special Controls.

Submitted by Forestadent Bernhard Forster GmbH (Appollo Beach, US). The FDA issued a Cleared decision on June 3, 2011 after a review of 123 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 Forestadent Bernhard Forster GmbH devices

Submission Details

510(k) Number K110275 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 2011
Decision Date June 03, 2011
Days to Decision 123 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
4d faster than avg
Panel avg: 127d · This submission: 123d
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 24
Devices cleared under the same product code (OAT) and FDA review panel - the closest regulatory comparables to K110275.
Anchor plate
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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