Cleared Special

FORTOSS VITAL

K082383 · Biocomposites, Ltd. · Dental

Sep 2008

Decision

17d

Days

Class 2

Risk

About This 510(k) Submission

K082383 is an FDA 510(k) clearance for the FORTOSS VITAL, 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 September 5, 2008, 17 days after receiving the submission on August 19, 2008. This device falls under the Dental review panel. Regulated under 21 CFR 872.3930.

Submission Details

510(k) Number	K082383 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 19, 2008
Decision Date	September 05, 2008
Days to Decision	17 days
Submission Type	Special
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.