Cleared Traditional

K131385 - EASY-GRAFT

K131385 is an FDA 510(k) clearance for EASY-GRAFT, manufactured by Degradable Solutions AG. The device is a Class 2 Dental device with product code LYC cleared through the Traditional 510(k) pathway after a 136-day FDA review.

K131385 · Degradable Solutions AG · Dental device
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Sep 2013
Decision
136d
Days
Class 2
Risk

K131385 is an FDA 510(k) clearance for the EASY-GRAFT. Classified as Bone Grafting Material, Synthetic (product code LYC), Class II - Special Controls.

Submitted by Degradable Solutions AG (Alexandria, US). The FDA issued a Cleared decision on September 27, 2013 after a review of 136 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 Degradable Solutions AG devices

FDA 510(k) Submission Details - K131385

510(k) Number K131385 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 2013
Decision Date September 27, 2013
Days to Decision 136 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d slower than avg
Panel avg: 127d · This submission: 136d
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 88
Devices cleared under the same product code (LYC) and FDA review panel - the closest regulatory comparables to K131385.
Cytrans Granules
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OSTEON III
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MASTERGRAFT PUTTY
K140374 · Medtronic Sofamor Danek USA, Inc. · Jun 2014
BONE PLUS BCP EAGLE EYE
K122240 · Megagen Implant Co., Ltd. · Aug 2012
OSTEON II
K112716 · Genoss Co., Ltd. · Jan 2012
NOVABONE DENTAL MORSELS - BIOACTIVE SYNTHETIC BONE GRAFT
K112428 · Novabone Products, LLC · Dec 2011