Cleared Traditional

K122894 - GEISTLICH BIO-OSS, GEISTLICH BIO-OSS COLLAGEN, GEISTLICH COMBI-KIT COLLAGEN, GEISTLICH PERIO SYSTEM COMBI PACK, GEISTLIC

K122894 is an FDA 510(k) clearance for GEISTLICH BIO-OSS, manufactured by Geistlich Pharma AG. The device is a Class 2 Dental device with product code NPM cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K122894 · Geistlich Pharma AG · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2013
Decision
148d
Days
Class 2
Risk

K122894 is an FDA 510(k) clearance for the GEISTLICH BIO-OSS, GEISTLICH BIO-OSS COLLAGEN, GEISTLICH COMBI-KIT COLLAGEN, .... 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 February 15, 2013 after a review of 148 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

FDA 510(k) Submission Details - K122894

510(k) Number K122894 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
21d slower than avg
Panel avg: 127d · This submission: 148d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NPM Device Classification - Class 2, Special Controls

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 36
Devices cleared under the same product code (NPM) and FDA review panel - the closest regulatory comparables to K122894.
TI-OSS
K140021 · Chiyewon · Jun 2015
PORCINE ANORGANIC BONE MINERAL
K140714 · Collagen Matrix, Inc. · Jul 2014
SYNERGY
K123876 · Odontit S.A. · May 2014
OCS-B
K113246 · Nibec Company, Limited · Jan 2013
CERASORB PLUS
K120152 · Riemser Arzneimittel AG · Aug 2012
GEISTLICH BIO-OSS PEN (0.25 G, 0.25-1.0MM GRANULES), GEISTLICH BIO-OSS PEN (0.5 G, 0.25-1.0MM GRANULES), GEISTLICH BIO-O
K120601 · Geistlich Pharma AG · May 2012