Cleared Traditional

GEISTLICH COMBI-KIT COLLEGEN

K112572 · Geistlich Pharma AG · Dental

Dec 2011

Decision

113d

Days

Class 2

Risk

About This 510(k) Submission

K112572 is an FDA 510(k) clearance for the GEISTLICH COMBI-KIT COLLEGEN, 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 December 28, 2011, 113 days after receiving the submission on September 6, 2011. This device falls under the Dental review panel. Regulated under 21 CFR 872.3930.

Submission Details

510(k) Number	K112572 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 06, 2011
Decision Date	December 28, 2011
Days to Decision	113 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.