Cleared Traditional

K112572 - GEISTLICH COMBI-KIT COLLEGEN

K112572 is the FDA 510(k) clearance for GEISTLICH COMBI-KIT COLLEGEN by Geistlich Pharma AG. It is a Class 2 Dental device (product code NPM) cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K112572 · Geistlich Pharma AG · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2011
Decision
113d
Days
Class 2
Risk

K112572 is an FDA 510(k) clearance for the GEISTLICH COMBI-KIT COLLEGEN. Classified as Bone Grafting Material, Animal Source (product code NPM), Class II - Special Controls.

Submitted by Geistlich Pharma AG (Washington, US). The FDA issued a Cleared decision on December 28, 2011 after a review of 113 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3930 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Geistlich Pharma AG devices

Submission Details

510(k) Number K112572 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 127d · This submission: 113d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NPM Bone Grafting Material, Animal Source
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - NPM Bone Grafting Material, Animal Source

All 20
Devices cleared under the same product code (NPM) and FDA review panel - the closest regulatory comparables to K112572.
Anorganic Bone Mineral in Delivery Applicator
K170541 · Collagen Matrix, Inc. · Jul 2017
Porcine Anorganic Bone Mineral in Delivery Applicator
K162158 · Collagen Matrix, Inc. · Feb 2017
PORCINE ANORGANIC BONE MINERAL
K140714 · Collagen Matrix, Inc. · Jul 2014
OSTEOGUIDE ANORGANIC BONE MINERAL PRODUCTS
K043034 · Collagen Matrix, Inc. · Aug 2005