Cleared Special

K010320 - MODIFICATION TO SYMPHONY GRAFT DELIVERY...

K010320 is an FDA 510(k) clearance for MODIFICATION TO SYMPHONY GRAFT DELIVERY..., manufactured by Depuyacromed. The device is a Class 2 Dental device with product code LYC cleared through the Special 510(k) pathway after a 27-day FDA review.

K010320 · Depuyacromed · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2001
Decision
27d
Days
Class 2
Risk

K010320 is an FDA 510(k) clearance for the MODIFICATION TO SYMPHONY GRAFT DELIVERY SYSTEM. Classified as Bone Grafting Material, Synthetic (product code LYC), Class II - Special Controls.

Submitted by Depuyacromed (Raynham, US). The FDA issued a Cleared decision on March 1, 2001 after a review of 27 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.

View all Depuyacromed devices

FDA 510(k) Submission Details - K010320

510(k) Number K010320 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 2001
Decision Date March 01, 2001
Days to Decision 27 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
100d faster than avg
Panel avg: 127d · This submission: 27d
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 64
Devices cleared under the same product code (LYC) and FDA review panel - the closest regulatory comparables to K010320.
BIOCELLECT
K010775 · Imtec Corp. · Jun 2001
MEDTRONIC SOFAMOR DANEK BIPHASIC CALCIUM PHOSPHATE (BCP) BONE VOID FILLER
K010701 · Medtronic Sofamor Danek USA, Inc. · Jun 2001
MIMIX BONE REPLACEMENT SYSTEM
K003494 · Biomet, Inc. · Apr 2001
3I CALCIUM SODIUM PHOSPHATE BONE CEMENT
K003493 · Biomet, Inc. · Feb 2001
SYMPHONY GRAFT DELIVERY SYSTEM
K003286 · Depuyacromed · Jan 2001
FORTOSS-CEMA
K993238 · Biocomposites, Ltd. · Jan 2000