Cleared Traditional

K091729 - ALPHA-BSM, BETA-BSM, GAMMA-BSM, EQUIVABONE

K091729 is an FDA 510(k) clearance for ALPHA-BSM, manufactured by Etex Corp.. The device is a Class 2 Dental device with product code LYC cleared through the Traditional 510(k) pathway after a 195-day FDA review.

K091729 · Etex Corp. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2009
Decision
195d
Days
Class 2
Risk

K091729 is an FDA 510(k) clearance for the ALPHA-BSM, BETA-BSM, GAMMA-BSM, EQUIVABONE. Classified as Bone Grafting Material, Synthetic (product code LYC), Class II - Special Controls.

Submitted by Etex Corp. (Cambridge, US). The FDA issued a Cleared decision on December 23, 2009 after a review of 195 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 - K091729

510(k) Number K091729 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 2009
Decision Date December 23, 2009
Days to Decision 195 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
67d slower than avg
Panel avg: 128d · This submission: 195d
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 202
Devices cleared under the same product code (LYC) and FDA review panel - the closest regulatory comparables to K091729.
NOVABONE DENTAL PUTTY-BIOACTIVE SYNTHETIC BONE GRAFT
K100671 · Novabone Products, LLC · Mar 2010
MBCP+
K093122 · Biomatlante · Mar 2010
MEDTRONIC DENTAL TCP
K092087 · Medtronic Sofamor Danek USA, Inc. · Dec 2009
PERIOPHIL BIPHASIC
K092788 · Cytophil, Inc. · Dec 2009
ARROWBONE-A, ARROWBONE-B
K083372 · Brainbase Corporation · Dec 2009
MODIFICATION TO UNIGRAFT
K092567 · Unicare Biomedical, Inc. · Nov 2009