Cleared Traditional

K111761 - NEO TITANIUM MESH, CTI-MEM

K111761 is an FDA 510(k) clearance for NEO TITANIUM MESH, manufactured by Neobiotech Co., Ltd.. The device is a Class 2 Dental device with product code JEY cleared through the Traditional 510(k) pathway after a 201-day FDA review.

K111761 · Neobiotech Co., Ltd. · Dental device
Download Printable Device Report (PDF)
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Jan 2012
Decision
201d
Days
Class 2
Risk

K111761 is an FDA 510(k) clearance for the NEO TITANIUM MESH, CTI-MEM. Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Neobiotech Co., Ltd. (Marietta, US). The FDA issued a Cleared decision on January 10, 2012 after a review of 201 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 Neobiotech Co., Ltd. devices

FDA 510(k) Submission Details - K111761

510(k) Number K111761 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 2011
Decision Date January 10, 2012
Days to Decision 201 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
73d slower than avg
Panel avg: 128d · This submission: 201d
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 266
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K111761.
ARTISAN SPACE MAINTENANCE SYSTEM
K120271 · Medtronic Sofamor Danek USA, Inc. · May 2012
LEFORTE SYSTEM BONE PLATE & SCREW
K112457 · Arkin Consulting Group · May 2012
RESORB X-G
K112064 · KLS-Martin L.P. · Mar 2012
SYNTHES MATRIXMANDIBLE PERFORMED RECONSTRUCTION PLATES
K113251 · Synthes, Inc. · Dec 2011
BONE PLATE
K110926 · Biomaterials Korea, Inc. · Dec 2011
ARCHITEX SPACE MAINTENANCE SYSTEM
K110259 · Medtronic Sofamor Danek USA, Inc. · Apr 2011