Cleared Traditional

K090793 - BONGROS HA

K090793 is an FDA 510(k) clearance for BONGROS HA, manufactured by Bioalpha, Inc.. The device is a Class 2 Dental device with product code LYC cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K090793 · Bioalpha, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2009
Decision
56d
Days
Class 2
Risk

K090793 is an FDA 510(k) clearance for the BONGROS HA. Classified as Bone Grafting Material, Synthetic (product code LYC), Class II - Special Controls.

Submitted by Bioalpha, Inc. (Seongnam, KR). The FDA issued a Cleared decision on May 19, 2009 after a review of 56 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K090793

510(k) Number K090793 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 2009
Decision Date May 19, 2009
Days to Decision 56 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
72d faster than avg
Panel avg: 128d · This submission: 56d
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 208
Devices cleared under the same product code (LYC) and FDA review panel - the closest regulatory comparables to K090793.
MODIFICATION TO UNIGRAFT
K092567 · Unicare Biomedical, Inc. · Nov 2009
ACTIFUSE BONE GRAFT SUBSTITUTE, ACTIFUSE MICROGRANULES BONE GRAFT SUBSTITUTE
K090850 · Apatech , Ltd. · Jul 2009
NOVABONE DENTAL PUTTY - BIOACTIVE SYNTHETIC BONE GRAFT
K091484 · Novabone Products, LLC · Jun 2009
CYTOFLEX RESORB, MODEL C03-0010 THROUGH C03-090
K090083 · Unicare Biomedical, Inc. · Mar 2009
BOND BONE
K083858 · Augma Biomaterials, Ltd. · Mar 2009
NANGEL
K083005 · Teknimed, S.A. · Mar 2009
K090793 · BONGROS HA
Download PDF FDA Summary Bioalpha, Inc.