Cleared Traditional

GEISTLICH PERIO-SYSTEM COMBI-PACK , GEISTLICH BIO-GIDE PERIO

K112575 · Geistlich Pharma AG · Dental

Dec 2011

Decision

112d

Days

Class 2

Risk

About This 510(k) Submission

K112575 is an FDA 510(k) clearance for the GEISTLICH PERIO-SYSTEM COMBI-PACK , GEISTLICH BIO-GIDE PERIO, 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 27, 2011, 112 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	K112575 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 06, 2011
Decision Date	December 27, 2011
Days to Decision	112 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.