Cleared Traditional

K140374 - MASTERGRAFT PUTTY

K140374 is an FDA 510(k) clearance for MASTERGRAFT PUTTY, manufactured by Medtronic Sofamor Danek USA, Inc.. The device is a Class 2 Dental device with product code LYC cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K140374 · Medtronic Sofamor Danek USA, Inc. · Dental device
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Jun 2014
Decision
116d
Days
Class 2
Risk

K140374 is an FDA 510(k) clearance for the MASTERGRAFT PUTTY. Classified as Bone Grafting Material, Synthetic (product code LYC), Class II - Special Controls.

Submitted by Medtronic Sofamor Danek USA, Inc. (Memphis, US). The FDA issued a Cleared decision on June 10, 2014 after a review of 116 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3930 - 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 Medtronic Sofamor Danek USA, Inc. devices

FDA 510(k) Submission Details - K140374

510(k) Number K140374 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 2014
Decision Date June 10, 2014
Days to Decision 116 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
11d faster than avg
Panel avg: 127d · This submission: 116d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LYC Device Classification - Class 2, Special Controls

Product Code LYC Bone Grafting Material, Synthetic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3930
Definition A Synthetic Bone Grafting Material Is Synthetically-derived Device, Such As Hydroxylapatite, Intended To Fill, Augment, Or Reconstruct Periodontal And Or Bony Defects Of The Upper Or Lower Jaw.
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 - LYC Bone Grafting Material, Synthetic

All 160
Devices cleared under the same product code (LYC) and FDA review panel - the closest regulatory comparables to K140374.
Cytrans Granules
K192597 · GC America, Inc. · Aug 2020
OSTEON III
K153676 · Genoss Co., Ltd. · Sep 2016
ShefaBone SCPC Resorbable Bone Graft
K153230 · The Implantech Inc./Shefabone · Jul 2016
BOND APATITE
K121177 · Augma Biomaterials, Ltd. · Dec 2013
EASY-GRAFT
K131385 · Degradable Solutions AG · Sep 2013
CURASAN OSSEOLIVE DENTAL
K111105 · Curasan AG · Dec 2012