Cleared Abbreviated

Cytrans Granules

K192597 · GC America, Inc. · Dental
Aug 2020
Decision
332d
Days
Class 2
Risk

About This 510(k) Submission

K192597 is an FDA 510(k) clearance for the Cytrans Granules, a Bone Grafting Material, Synthetic (Class II — Special Controls, product code LYC), submitted by GC America, Inc. (Alsip, US). The FDA issued a Cleared decision on August 17, 2020, 332 days after receiving the submission on September 20, 2019. This device falls under the Dental review panel. Regulated under 21 CFR 872.3930.

Submission Details

510(k) Number K192597 FDA.gov
FDA Decision Cleared SESE
Date Received September 20, 2019
Decision Date August 17, 2020
Days to Decision 332 days
Submission Type Abbreviated
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.