Cleared Traditional

ARROWBONE-A, ARROWBONE-B

K083372 · Brainbase Corporation · Dental

Dec 2009

Decision

389d

Days

Class 2

Risk

About This 510(k) Submission

K083372 is an FDA 510(k) clearance for the ARROWBONE-A, ARROWBONE-B, a Bone Grafting Material, Synthetic (Class II — Special Controls, product code LYC), submitted by Brainbase Corporation (Bonita Springs, US). The FDA issued a Cleared decision on December 8, 2009, 389 days after receiving the submission on November 14, 2008. This device falls under the Dental review panel. Regulated under 21 CFR 872.3930.

Submission Details

510(k) Number	K083372 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 14, 2008
Decision Date	December 08, 2009
Days to Decision	389 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF

Device Classification

Product Code	LYC — Bone Grafting Material, Synthetic
Device Class	Class II — 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.