Cleared Traditional

K093122 - MBCP+

K093122 is an FDA 510(k) clearance for MBCP+, manufactured by Biomatlante. The device is a Class 2 Dental device with product code LYC cleared through the Traditional 510(k) pathway after a 164-day FDA review.

K093122 · Biomatlante · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2010
Decision
164d
Days
Class 2
Risk

K093122 is an FDA 510(k) clearance for the MBCP+. Classified as Bone Grafting Material, Synthetic (product code LYC), Class II - Special Controls.

Submitted by Biomatlante (Vigneux De Bretagne, FR). The FDA issued a Cleared decision on March 15, 2010 after a review of 164 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.

View all Biomatlante devices

FDA 510(k) Submission Details - K093122

510(k) Number K093122 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 2009
Decision Date March 15, 2010
Days to Decision 164 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d slower than avg
Panel avg: 127d · This submission: 164d
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 126
Devices cleared under the same product code (LYC) and FDA review panel - the closest regulatory comparables to K093122.
BONE PLUS BCP
K090950 · Megagen Implant Co., Ltd. · Jul 2010
HEALOS DENTAL BONE GRAFT SUBSTITUTE (ALSO CALLED HEALOS OR HEALOS II) MODEL 6008, 6025
K093390 · Depuy Spine, Inc. · May 2010
NOVABONE DENTAL PUTTY-BIOACTIVE SYNTHETIC BONE GRAFT
K100671 · Novabone Products, LLC · Mar 2010
MEDTRONIC DENTAL TCP
K092087 · Medtronic Sofamor Danek USA, Inc. · Dec 2009
ALPHA-BSM, BETA-BSM, GAMMA-BSM, EQUIVABONE
K091729 · Etex Corp. · Dec 2009
NOVABONE DENTAL PUTTY - BIOACTIVE SYNTHETIC BONE GRAFT
K091484 · Novabone Products, LLC · Jun 2009