Cleared Special

K082383 - FORTOSS VITAL

K082383 is an FDA 510(k) clearance for FORTOSS VITAL, manufactured by Biocomposites, Ltd.. The device is a Class 2 Dental device with product code LYC cleared through the Special 510(k) pathway after a 17-day FDA review.

K082383 · Biocomposites, Ltd. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2008
Decision
17d
Days
Class 2
Risk

K082383 is an FDA 510(k) clearance for the FORTOSS VITAL. Classified as Bone Grafting Material, Synthetic (product code LYC), Class II - Special Controls.

Submitted by Biocomposites, Ltd. (Keele, GB). The FDA issued a Cleared decision on September 5, 2008 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3930 - the FDA dental device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K082383

510(k) Number K082383 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
111d faster than avg
Panel avg: 128d · This submission: 17d
Pathway characteristics
Modification to existing cleared device.

LYC Device Classification - Class 2, Special Controls

Product Code LYC Bone Grafting Material, Synthetic
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - LYC Bone Grafting Material, Synthetic

All 230
Devices cleared under the same product code (LYC) and FDA review panel - the closest regulatory comparables to K082383.
SYNOSS COLLAGEN SYNTHETIC MINERAL-COLLAGEN BONE GRAFT MATRIX
K083742 · Collagen Matrix, Inc. · Feb 2009
MASTERGRAFT RESORBABLE CERAMIC GRANULES
K082917 · Medtronic Sofamor Danek · Jan 2009
MASTERGRAFT PUTTY
K081784 · Medtronic Sofamor Danek · Sep 2008
HEALOS II BONE GRAFT SUBSTITUTE
K081432 · Depuy Spine, Inc. · Aug 2008
TRICOS A RESORBABLE SUBSTITUTE
K081721 · Baxter Healthcare Corp · Aug 2008
OSFERION D
K081561 · Olympus Terumo Biomaterials Corporation · Jul 2008
K082383 · FORTOSS VITAL
Download PDF FDA Summary Biocomposites, Ltd.