Cleared Traditional

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) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K120601 · Geistlich Pharma AG · Dental device
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May 2012
Decision
86d
Days
Class 2
Risk

K120601 is an FDA 510(k) clearance for the GEISTLICH BIO-OSS PEN (0.25 G, 0.25-1.0MM GRANULES), GEISTLICH BIO-OSS PEN (0.... 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 May 24, 2012 after a review of 86 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Geistlich Pharma AG devices

Submission Details

510(k) Number K120601 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 2012
Decision Date May 24, 2012
Days to Decision 86 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
41d faster than avg
Panel avg: 127d · This submission: 86d
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 38
Devices cleared under the same product code (NPM) and FDA review panel - the closest regulatory comparables to K120601.
Geistlich Bio-Oss®
K251786 · Geistlich Pharma AG · Jul 2025
SwissGraft X
K251613 · Geistlich Pharma AG · Jun 2025
Geistlich Bio-Flow®
K242510 · Geistlich Pharma AG · Mar 2025
Xenograft Bovine Bone Particulate
K240133 · Collagen Solutions, LLC · Aug 2024
THE Graft Collagen
K230305 · Purgo Biologics, Inc. · Jul 2024
Geistlich Bio-Oss®
K240661 · Geistlich Pharma AG · Jul 2024