Cytrans Elashield— 510(k) K253317
Substantially EquivalentGC America, Inc.
FDA 510(k) clearance K253317 for Cytrans Elashield, Substantially Equivalent on 2026-07-06. Applicant: GC America, Inc.. Device class: 2.
Summary
GC America's Cytrans Elashield is filed under LYC, synthetic bone grafting material. The record doesn't give the material's composition or form.
Class II, 21 CFR 872.3930. Dental is both the classification panel and the review panel, and it was a Traditional 510(k).
GC America filed from Alsip, Illinois. Review took 279 calendar days (September 30, 2025 to July 6, 2026).
Clearance details
- Applicant
- GC America, Inc.
- Product code
- Product code LYC
- Device class
- Class 2
- Regulation
- 21 CFR 872.3930
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Alsip, IL, US
Recent devices under product code LYC
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