Cleared Traditional

BONE PLATE (K110926) - FDA 510(k) Clearance

Also marketed or referenced as:
BONE SCREW

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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 96
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K110926.
Stryker Upper-Face AXS screws and Mid-Face AXS screws
K172572 · Stryker · Oct 2017
MP LeFort I Plates
K171364 · Stryker · Jul 2017
ARTISAN SPACE MAINTENANCE SYSTEM
K120271 · Medtronic Sofamor Danek USA, Inc. · May 2012
ARCHITEX SPACE MAINTENANCE SYSTEM
K110259 · Medtronic Sofamor Danek USA, Inc. · Apr 2011
SYNTHES DENTOALVEOLAR BONE FIXATION SYSTEM
K102656 · Synthes (Usa) · Dec 2010
SUSTAIN SPACE MAINTENANCE SYSTEM
K100779 · Medtronic Sofamor Danek USA, Inc. · Dec 2010