Cytrans Elashield— 510(k) K253317

Substantially Equivalent

GC America, Inc.

FDA 510(k) clearance K253317 for Cytrans Elashield, Substantially Equivalent on 2026-07-06. Applicant: GC America, Inc.. Device class: 2.

Clearance details

Applicant: GC America, Inc.
Product code: Code LYC
Device class: Class 2
Regulation: 21 CFR 872.3930
Advisory panel: Dental
Date received: 2025-09-30
Decision date: 2026-07-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Alsip, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LYC

K253883 — Bonalive Maxillofacial2026-05-14
K251818 — BONTREE PLUS2026-03-06
K244006 — FG Bone Graft M2025-09-17
K243745 — FG Bone Graft B2025-08-29
K241186 — Synthetic Bone Graft Particulate2025-02-21

More clearances from GC America, Inc.

K261246 — SRGC-062026-06-18
K254109 — G-CEM UNIVERSAL2026-05-18
K251124 — G-Bond Universal2025-10-02
K250953 — EQUIA LC ONE2025-09-19
K251946 — G aenial Universal Injectable II2025-08-29

Data sourced from openFDA. This site is unofficial and independent of the FDA.