Cleared Abbreviated

BIOACTYS (K082286) - FDA 510(k) Clearance

Class II Dental device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K082286 · Graftys · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2009
Decision
197d
Days
Class 2
Risk

K082286 is an FDA 510(k) clearance for the BIOACTYS. Classified as Bone Grafting Material, Synthetic (product code LYC), Class II - Special Controls.

Submitted by Graftys (Aix En Provence, FR). The FDA issued a Cleared decision on February 24, 2009 after a review of 197 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3930 - the FDA dental device regulatory framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Graftys devices

Submission Details

510(k) Number K082286 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 2008
Decision Date February 24, 2009
Days to Decision 197 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d slower than avg
Panel avg: 127d · This submission: 197d
Pathway characteristics
Standards-based clearance path.

Device Classification

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 28
Devices cleared under the same product code (LYC) and FDA review panel - the closest regulatory comparables to K082286.
Cytrans Granules
K192597 · GC America, Inc. · Aug 2020
MASTERGRAFT PUTTY
K140374 · Medtronic Sofamor Danek USA, Inc. · Jun 2014
MEDTRONIC DENTAL TCP
K092087 · Medtronic Sofamor Danek USA, Inc. · Dec 2009
MASTERGRAFT RESORBABLE CERAMIC GRANULES
K082917 · Medtronic Sofamor Danek · Jan 2009
MASTERGRAFT PUTTY
K081784 · Medtronic Sofamor Danek · Sep 2008
TRICOS A RESORBABLE SUBSTITUTE
K081721 · Baxter Healthcare Corp · Aug 2008