Cleared Traditional

K092087 - MEDTRONIC DENTAL TCP

K092087 is an FDA 510(k) clearance for MEDTRONIC DENTAL TCP, manufactured by Medtronic Sofamor Danek USA, Inc.. The device is a Class 2 Dental device with product code LYC cleared through the Traditional 510(k) pathway after a 174-day FDA review.

K092087 · Medtronic Sofamor Danek USA, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2009
Decision
174d
Days
Class 2
Risk

K092087 is an FDA 510(k) clearance for the MEDTRONIC DENTAL TCP. Classified as Bone Grafting Material, Synthetic (product code LYC), Class II - Special Controls.

Submitted by Medtronic Sofamor Danek USA, Inc. (Memphis, US). The FDA issued a Cleared decision on December 30, 2009 after a review of 174 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3930 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K092087

510(k) Number K092087 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 2009
Decision Date December 30, 2009
Days to Decision 174 days
Submission Type Traditional
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
46d slower than avg
Panel avg: 128d · This submission: 174d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 230
Devices cleared under the same product code (LYC) and FDA review panel - the closest regulatory comparables to K092087.
PERIOPHIL B-TCP
K093871 · Cytophil, Inc. · Apr 2010
NOVABONE DENTAL PUTTY-BIOACTIVE SYNTHETIC BONE GRAFT
K100671 · Novabone Products, LLC · Mar 2010
MBCP+
K093122 · Biomatlante · Mar 2010
ALPHA-BSM, BETA-BSM, GAMMA-BSM, EQUIVABONE
K091729 · Etex Corp. · Dec 2009
PERIOPHIL BIPHASIC
K092788 · Cytophil, Inc. · Dec 2009
ARROWBONE-A, ARROWBONE-B
K083372 · Brainbase Corporation · Dec 2009
K092087 · MEDTRONIC DENTAL TCP
Download PDF FDA Summary Medtronic Sofamor Dan…