REPROBONE DENTAL GRAFTING MATERIAL— 510(k) K103820

Name: FDA 510(k) clearance K103820
Creator: U.S. Food and Drug Administration
Published: 2011-11-03

Substantially Equivalent

Ceramisys, Ltd.

FDA 510(k) clearance K103820 for REPROBONE DENTAL GRAFTING MATERIAL, Substantially Equivalent on 2011-11-03. Applicant: Ceramisys, Ltd.. Device class: 2.

Clearance details

Applicant: Ceramisys, Ltd.
Product code: Code LYC
Device class: Class 2
Regulation: 21 CFR 872.3930
Advisory panel: Dental
Date received: 2010-12-30
Decision date: 2011-11-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Centercille, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LYC

view all

K253317 — Cytrans Elashield2026-07-06
K253883 — Bonalive Maxillofacial2026-05-14
K251818 — BONTREE PLUS2026-03-06
K244006 — FG Bone Graft M2025-09-17
K243745 — FG Bone Graft B2025-08-29

More clearances from Ceramisys, Ltd.

view all

K110554 — BIOCERAMIC ORBITAL IMPLANT, ORBTEX2011-11-02

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