K253317

Cytrans™ Elashield

510(k) number
K253317
Device name
Cytrans™ Elashield
Applicant
GC America, Inc. IL · US
Product code
LYC — Bone Grafting Material, Synthetic
Decision date
2026-07-06
Date received
2025-09-30
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Dental
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain

Also available from FDA: K253317.pdf

Official FDA record: K253317
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.