Cleared Traditional

GEISTLICH BIO-OSS, GEISTLICH BIO-OSS COLLAGEN, GEISTLICH COMBI-KIT COLLAGEN, GEISTLICH PERIO SYSTEM COMBI PACK, GEISTLIC

K122894 · Geistlich Pharma AG · Dental

Feb 2013

Decision

148d

Days

Class 2

Risk

About This 510(k) Submission

K122894 is an FDA 510(k) clearance for the GEISTLICH BIO-OSS, GEISTLICH BIO-OSS COLLAGEN, GEISTLICH COMBI-KIT COLLAGEN, GEISTLICH PERIO SYSTEM COMBI PACK, GEISTLIC, a Bone Grafting Material, Animal Source (Class II — Special Controls, product code NPM), submitted by Geistlich Pharma AG (Washington, US). The FDA issued a Cleared decision on February 15, 2013, 148 days after receiving the submission on September 20, 2012. This device falls under the Dental review panel. Regulated under 21 CFR 872.3930.

Submission Details

510(k) Number	K122894 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 20, 2012
Decision Date	February 15, 2013
Days to Decision	148 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF

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.