Cleared Traditional

K030052 - OSTIM
(FDA 510(k) Clearance)

K030052 · Heraeus Kulzer, Inc. · Dental

Dec 2004

Decision

700d

Days

Class 2

Risk

K030052 is an FDA 510(k) clearance for the OSTIM. This device is classified as a Bone Grafting Material, Synthetic (Class II — Special Controls, product code LYC).

Submitted by Heraeus Kulzer, Inc. (South Bend, US). The FDA issued a Cleared decision on December 6, 2004, 700 days after receiving the submission on January 6, 2003.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3930. 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..

Submission Details

510(k) Number	K030052 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 06, 2003
Decision Date	December 06, 2004
Days to Decision	700 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement

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.