Cleared Traditional

K173594 - Straumann cerabone

K173594 is the FDA 510(k) clearance for Straumann cerabone by Institut Straumann AG. It is a Class 2 Dental device (product code NPM) cleared through the Traditional 510(k) pathway after a 332-day FDA review.

K173594 · Institut Straumann AG · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2018
Decision
332d
Days
Class 2
Risk

K173594 is an FDA 510(k) clearance for the Straumann cerabone. Classified as Bone Grafting Material, Animal Source (product code NPM), Class II - Special Controls.

Submitted by Institut Straumann AG (Basel, CH). The FDA issued a Cleared decision on October 19, 2018 after a review of 332 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Institut Straumann AG devices

Submission Details

510(k) Number K173594 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2017
Decision Date October 19, 2018
Days to Decision 332 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
205d slower than avg
Panel avg: 127d · This submission: 332d
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 Consultant

Straumann USA, LLC
Jennifer M. Jackson

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - NPM Bone Grafting Material, Animal Source

All 19
Devices cleared under the same product code (NPM) and FDA review panel - the closest regulatory comparables to K173594.
Porcine Mineral Collagen Composite Moldable
K201859 · Collagen Matrix, Inc. · Sep 2020
DSM Biomedical Dental Bone Graft Plus
K193212 · Dsm Biomedical · Sep 2020
The Graft Bone Substitute
K191737 · Purgo Biologics, Inc. · Feb 2020
The Graft Natural Bone Substitute
K173188 · Purgo Biologics, Inc. · Jul 2018
Anorganic Bone Mineral with Collagen in Delivery Applicator
K171008 · Collagen Matrix, Inc. · Oct 2017
Anorganic Bone Mineral in Delivery Applicator
K170541 · Collagen Matrix, Inc. · Jul 2017