Cleared Special

K072058 - MODIFICATION TO: OSTEOGRAF/N-700

K072058 is an FDA 510(k) clearance for MODIFICATION TO: OSTEOGRAF/N-700, 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 8-day FDA review.

K072058 · Dentsply Interntional · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2007
Decision
8d
Days
Class 2
Risk

K072058 is an FDA 510(k) clearance for the MODIFICATION TO: OSTEOGRAF/N-700. 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 August 3, 2007 after a review of 8 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 - K072058

510(k) Number K072058 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 2007
Decision Date August 03, 2007
Days to Decision 8 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
120d faster than avg
Panel avg: 128d · This submission: 8d
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 K072058.
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
INION BIORESTORE
K070784 · Inion OY · Jul 2007
BONALIVE GRANULES AND BONALIVE PLATES
K070055 · Vivoxid , Ltd. · Jun 2007
RTR SYRINGE
K063634 · Septodont · May 2007
K072058 · MODIFICATION TO: OSTEOGRAF/N-700
Download PDF FDA Summary Dentsply Interntional