Cleared Abbreviated

K053374 - OSSAPLAST DENTAL (PARTICLE SIZE OF 500 TO 1000 UM TO 2000 UM)

K053374 is an FDA 510(k) clearance for OSSAPLAST DENTAL (PARTICLE SIZE OF 500 ..., manufactured by Ossacur AG. The device is a Class 2 Dental device with product code LYC cleared through the Abbreviated 510(k) pathway after a 78-day FDA review.

K053374 · Ossacur AG · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2006
Decision
78d
Days
Class 2
Risk

K053374 is an FDA 510(k) clearance for the OSSAPLAST DENTAL (PARTICLE SIZE OF 500 TO 1000 UM TO 2000 UM). Classified as Bone Grafting Material, Synthetic (product code LYC), Class II - Special Controls.

Submitted by Ossacur AG (Santa Barbara, US). The FDA issued a Cleared decision on February 21, 2006 after a review of 78 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. 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 Ossacur AG devices

FDA 510(k) Submission Details - K053374

510(k) Number K053374 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 2005
Decision Date February 21, 2006
Days to Decision 78 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
49d faster than avg
Panel avg: 127d · This submission: 78d
Pathway characteristics
Standards-based clearance path.

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 141
Devices cleared under the same product code (LYC) and FDA review panel - the closest regulatory comparables to K053374.
OSTEON, MODELS GBG0305, GBG0510, GBG1020, GBG2030, GBG3040, GBG4050
K062834 · Genoss Co., Ltd. · Apr 2007
PERIOGLAS PUTTY-BIOACTIVE BONE GRAFT GEL
K063596 · Novabone Products, LLC · Feb 2007
NOVABONE DENTAL PUTTY-BIOACTIVE SYNTHETIC BONE GRAFT
K063549 · Novabone Products, LLC · Feb 2007
PERIOGLAS BONE GRAFT PARTICULATE
K053387 · Novabone Products, LLC · Feb 2006
SYNTHES (USA) CHRONOS-BETA-TCP
K053022 · Synthes (Usa) · Jan 2006
FORTOSS VITAL BONE GRAFT SUBSTITUTE
K050170 · Biocomposites, Ltd. · Aug 2005