Cleared Traditional

K153230 - ShefaBone SCPC Resorbable Bone Graft

K153230 is an FDA 510(k) clearance for ShefaBone SCPC Resorbable Bone Graft, manufactured by The Implantech Inc./Shefabone. The device is a Class 2 Dental device with product code LYC cleared through the Traditional 510(k) pathway after a 251-day FDA review.

K153230 · The Implantech Inc./Shefabone · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2016
Decision
251d
Days
Class 2
Risk

K153230 is an FDA 510(k) clearance for the ShefaBone SCPC Resorbable Bone Graft. Classified as Bone Grafting Material, Synthetic (product code LYC), Class II - Special Controls.

Submitted by The Implantech Inc./Shefabone (Charlotte, US). The FDA issued a Cleared decision on July 14, 2016 after a review of 251 days - an extended review cycle.

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.

FDA 510(k) Submission Details - K153230

510(k) Number K153230 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 2015
Decision Date July 14, 2016
Days to Decision 251 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
123d slower than avg
Panel avg: 128d · This submission: 251d
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 Consultant

Paladin Medical, Inc.
ELAINE DUNCAN

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LYC Bone Grafting Material, Synthetic

All 205
Devices cleared under the same product code (LYC) and FDA review panel - the closest regulatory comparables to K153230.
Straumann BoneCeramic
K201051 · Institut Straumann AG · Sep 2020
Cytrans Granules
K192597 · GC America, Inc. · Aug 2020
OSTEON III
K153676 · Genoss Co., Ltd. · Sep 2016
MASTERGRAFT PUTTY
K140374 · Medtronic Sofamor Danek USA, Inc. · Jun 2014
BOND APATITE
K121177 · Augma Biomaterials, Ltd. · Dec 2013
EASY-GRAFT
K131385 · Degradable Solutions AG · Sep 2013
K153230 · ShefaBone SCPC Resorbable Bone Graft
Download PDF FDA Summary The Implantech Inc./S…