Cleared Abbreviated

K192597 - Cytrans Granules

K192597 is the FDA 510(k) clearance for Cytrans Granules by GC America, Inc.. It is a Class 2 Dental device (product code LYC) cleared through the Abbreviated 510(k) pathway after a 332-day FDA review.

K192597 · GC America, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2020
Decision
332d
Days
Class 2
Risk

K192597 is an FDA 510(k) clearance for the Cytrans Granules. Classified as Bone Grafting Material, Synthetic (product code LYC), Class II - Special Controls.

Submitted by GC America, Inc. (Alsip, US). The FDA issued a Cleared decision on August 17, 2020 after a review of 332 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3930 - the FDA dental device regulatory framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all GC America, Inc. devices

Submission Details

510(k) Number K192597 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 2019
Decision Date August 17, 2020
Days to Decision 332 days
Submission Type Abbreviated
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
205d slower than avg
Panel avg: 127d · This submission: 332d
Pathway characteristics
Standards-based clearance path.

Device Classification

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

Wood Burditt Group
H. Carl Jenkins

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 42
Devices cleared under the same product code (LYC) and FDA review panel - the closest regulatory comparables to K192597.
InRoad® Dental Synthetic Bone Graft
K202675 · Osteogene Tech Corp · Mar 2022
OsOpia Synthetic Bone Void Filler
K201546 · Revisios BV · Oct 2020
Straumann BoneCeramic
K201051 · Institut Straumann AG · Sep 2020
MASTERGRAFT PUTTY
K140374 · Medtronic Sofamor Danek USA, Inc. · Jun 2014
HEALOS DENTAL BONE GRAFT SUBSTITUTE (ALSO CALLED HEALOS OR HEALOS II) MODEL 6008, 6025
K093390 · Depuy Spine, Inc. · May 2010
MEDTRONIC DENTAL TCP
K092087 · Medtronic Sofamor Danek USA, Inc. · Dec 2009