Cleared Special

K071817 - OSTEOGRAF/N-300

K071817 is an FDA 510(k) clearance for OSTEOGRAF/N-300, manufactured by Dentsply Interntional. The device is a Class 2 Dental device with product code LYC cleared through the Special 510(k) pathway after a 63-day FDA review.

K071817 · Dentsply Interntional · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2007
Decision
63d
Days
Class 2
Risk

K071817 is an FDA 510(k) clearance for the OSTEOGRAF/N-300. Classified as Bone Grafting Material, Synthetic (product code LYC), Class II - Special Controls.

Submitted by Dentsply Interntional (York, US). The FDA issued a Cleared decision on September 4, 2007 after a review of 63 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 - K071817

510(k) Number K071817 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 2007
Decision Date September 04, 2007
Days to Decision 63 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
65d faster than avg
Panel avg: 128d · This submission: 63d
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 208
Devices cleared under the same product code (LYC) and FDA review panel - the closest regulatory comparables to K071817.
BIO-SCAFFOLD BIOSCAFF ALVELAC RESOBABLE SCAFFOLD
K080308 · Bioscaffold International Pte, Ltd. · Apr 2008
TRICOS T RESORBABLE BONE SUBSTITUTE
K073571 · Baxter Healthcare Corporation · Apr 2008
SYNOSS SYNTHETIC BONE GRAFT MATERIAL
K072397 · Collagen Matrix, Inc. · Oct 2007
OSTEOGRAF/D-300
K072052 · Dentsply International, Inc. · Aug 2007
OSTEOGRAF/D-700
K072056 · Dentsply International, Inc. · Aug 2007
OSTEOGRAF/LD-300
K072057 · Dentsply International, Inc. · Aug 2007
K071817 · OSTEOGRAF/N-300
Download PDF FDA Summary Dentsply Interntional