Cleared Traditional

FORTOSS VITAL BONE GRAFT SUBSTITUTE

K050170 · Biocomposites, Ltd. · Dental

Aug 2005

Decision

212d

Days

Class 2

Risk

About This 510(k) Submission

K050170 is an FDA 510(k) clearance for the FORTOSS VITAL BONE GRAFT SUBSTITUTE, a Bone Grafting Material, Synthetic (Class II — Special Controls, product code LYC), submitted by Biocomposites, Ltd. (Keele, GB). The FDA issued a Cleared decision on August 26, 2005, 212 days after receiving the submission on January 26, 2005. This device falls under the Dental review panel. Regulated under 21 CFR 872.3930.

Submission Details

510(k) Number	K050170 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 26, 2005
Decision Date	August 26, 2005
Days to Decision	212 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.