Cleared Abbreviated

CERASORB DENTAL, CERASORB M DENTAL AND CERASORB PERIO (K051443) - FDA 510(k) Clearance

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

K051443 · Curasan Ag, Frankfurt Facility · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2005
Decision
50d
Days
Class 2
Risk

K051443 is an FDA 510(k) clearance for the CERASORB DENTAL, CERASORB M DENTAL AND CERASORB PERIO. Classified as Bone Grafting Material, Synthetic (product code LYC), Class II - Special Controls.

Submitted by Curasan Ag, Frankfurt Facility (Garner,, US). The FDA issued a Cleared decision on July 22, 2005 after a review of 50 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 Curasan Ag, Frankfurt Facility devices

Submission Details

510(k) Number K051443 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 2005
Decision Date July 22, 2005
Days to Decision 50 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
77d faster than avg
Panel avg: 127d · This submission: 50d
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 229
Devices cleared under the same product code (LYC) and FDA review panel - the closest regulatory comparables to K051443.
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