Cleared Traditional

K110926 - BONE PLATE

Also marketed or referenced as:
BONE SCREW

K110926 is an FDA 510(k) clearance for BONE PLATE, manufactured by Biomaterials Korea, Inc.. The device is a Class 2 Dental device with product code JEY cleared through the Traditional 510(k) pathway after a 251-day FDA review.

K110926 · Biomaterials Korea, Inc. · Dental device
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Dec 2011
Decision
251d
Days
Class 2
Risk

K110926 is an FDA 510(k) clearance for the BONE PLATE. Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Biomaterials Korea, Inc. (Greenwood Village, US). The FDA issued a Cleared decision on December 8, 2011 after a review of 251 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4760 - 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 Biomaterials Korea, Inc. devices

FDA 510(k) Submission Details - K110926

510(k) Number K110926 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 2011
Decision Date December 08, 2011
Days to Decision 251 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
124d slower than avg
Panel avg: 127d · This submission: 251d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JEY Device Classification - Class 2, Special Controls

Product Code JEY Plate, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4760
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 - JEY Plate, Bone

All 194
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K110926.
BIOMET MICROFIXATION MANDIBULAR FRACTURE/ RECONSTRUCTION DEVICES AND PREBENT PLATES SYSTEM
K113512 · Biomet Microfixation · Jun 2012
ARTISAN SPACE MAINTENANCE SYSTEM
K120271 · Medtronic Sofamor Danek USA, Inc. · May 2012
RESORB X-G
K112064 · KLS-Martin L.P. · Mar 2012
ARCHITEX SPACE MAINTENANCE SYSTEM
K110259 · Medtronic Sofamor Danek USA, Inc. · Apr 2011
SURGICASE CMF, SURGICASE CONNECT, SURGICASE GUIDE
K103136 · Materialise NV · Mar 2011
LEFORTE NEURO SYSTEM BONE PLATE
K103778 · Jeil Medical Corporation · Jan 2011