Cleared Traditional

K253317 - Cytrans Elashield

K253317 is the FDA 510(k) clearance for Cytrans Elashield by GC America, Inc.. It is a Class 2 Dental device (product code LYC) cleared through the Traditional 510(k) pathway after a 279-day FDA review.

K253317 · GC America, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2026
Decision
279d
Days
Class 2
Risk

K253317 is an FDA 510(k) clearance for the Cytrans™ Elashield. 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 July 6, 2026 after a review of 279 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.

View all GC America, Inc. devices

Submission Details

510(k) Number K253317 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2025
Decision Date July 06, 2026
Days to Decision 279 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
152d slower than avg
Panel avg: 127d · This submission: 279d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 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 K253317.
Bonalive Maxillofacial
K253883 · Bonalive , Ltd. · May 2026
BONTREE PLUS
K251818 · Hudens Bio Co., Ltd. · Mar 2026
FG Bone Graft M
K244006 · Full Golden Biotech Co., Ltd. · Sep 2025
FG Bone Graft B
K243745 · Full Golden Biotech Corporation · Aug 2025
Synthetic Bone Graft Particulate
K241186 · Shenzhen Dazhou Medical Technology Co., Ltd. · Feb 2025
CMFlexTM
K213260 · Dimension Inx Corp. · Dec 2022