Cleared Traditional

A-Oss

K151542 · Hiossen, Inc. · Dental

Aug 2016

Decision

422d

Days

Class 2

Risk

About This 510(k) Submission

K151542 is an FDA 510(k) clearance for the A-Oss, a Bone Grafting Material, Animal Source (Class II — Special Controls, product code NPM), submitted by Hiossen, Inc. (Fariless Hills, US). The FDA issued a Cleared decision on August 3, 2016, 422 days after receiving the submission on June 8, 2015. This device falls under the Dental review panel. Regulated under 21 CFR 872.3930.

Submission Details

510(k) Number	K151542 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 08, 2015
Decision Date	August 03, 2016
Days to Decision	422 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement

Device Classification

Product Code	NPM — Bone Grafting Material, Animal Source
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 872.3930
Definition	A Animal-source Bone Grafting Material Is A Naturally-derived Device, Such As Collagen, Intended To Fill, Augment, Or Reconstruct Periodontal Defects And Or Bony Defects Of The Upper Or Lower Jaw.