Cleared Traditional

Synthetic Bone Graft Particulate

K241186 · Shenzhen Dazhou Medical Technology Co., Ltd. · Dental
Feb 2025
Decision
298d
Days
Class 2
Risk

About This 510(k) Submission

K241186 is an FDA 510(k) clearance for the Synthetic Bone Graft Particulate, a Bone Grafting Material, Synthetic (Class II — Special Controls, product code LYC), submitted by Shenzhen Dazhou Medical Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on February 21, 2025, 298 days after receiving the submission on April 29, 2024. This device falls under the Dental review panel. Regulated under 21 CFR 872.3930.

Submission Details

510(k) Number K241186 FDA.gov
FDA Decision Cleared SESE
Date Received April 29, 2024
Decision Date February 21, 2025
Days to Decision 298 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code LYC — Bone Grafting Material, Synthetic
Device Class Class II — 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.