Cleared Traditional

INION BIORESTORE

K070784 · Inion OY · Dental

Jul 2007

Decision

125d

Days

Class 2

Risk

About This 510(k) Submission

K070784 is an FDA 510(k) clearance for the INION BIORESTORE, a Bone Grafting Material, Synthetic (Class II — Special Controls, product code LYC), submitted by Inion OY (Tampere, FI). The FDA issued a Cleared decision on July 24, 2007, 125 days after receiving the submission on March 21, 2007. This device falls under the Dental review panel. Regulated under 21 CFR 872.3930.

Submission Details

510(k) Number	K070784 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 21, 2007
Decision Date	July 24, 2007
Days to Decision	125 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.