Cleared Traditional

K112064 - RESORB X-G

K112064 is an FDA 510(k) clearance for RESORB X-G, manufactured by KLS-Martin L.P.. The device is a Class 2 Dental device with product code JEY cleared through the Traditional 510(k) pathway after a 248-day FDA review.

K112064 · KLS-Martin L.P. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2012
Decision
248d
Days
Class 2
Risk

K112064 is an FDA 510(k) clearance for the RESORB X-G. Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by KLS-Martin L.P. (Jacksonville, US). The FDA issued a Cleared decision on March 23, 2012 after a review of 248 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 KLS-Martin L.P. devices

FDA 510(k) Submission Details - K112064

510(k) Number K112064 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 2011
Decision Date March 23, 2012
Days to Decision 248 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
121d slower than avg
Panel avg: 127d · This submission: 248d
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 249
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K112064.
SYNTHES MATRIXMADIBLE PLATE AND SCREW SYSTEM
K121574 · Synthes, Inc. · Jun 2012
ARTISAN SPACE MAINTENANCE SYSTEM
K120271 · Medtronic Sofamor Danek USA, Inc. · May 2012
LEFORTE SYSTEM BONE PLATE & SCREW
K112457 · Arkin Consulting Group · May 2012
NEO TITANIUM MESH, CTI-MEM
K111761 · Neobiotech Co., Ltd. · Jan 2012
SYNTHES MATRIXMANDIBLE PERFORMED RECONSTRUCTION PLATES
K113251 · Synthes, Inc. · Dec 2011
BONE PLATE
K110926 · Biomaterials Korea, Inc. · Dec 2011