Cleared Traditional

DSM Biomedical Dental Bone Graft Plus (K193212) - FDA 510(k) Clearance

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

K193212 · Dsm Biomedical · Dental device
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Sep 2020
Decision
294d
Days
Class 2
Risk

K193212 is an FDA 510(k) clearance for the DSM Biomedical Dental Bone Graft Plus. Classified as Bone Grafting Material, Animal Source (product code NPM), Class II - Special Controls.

Submitted by Dsm Biomedical (Exton, US). The FDA issued a Cleared decision on September 10, 2020 after a review of 294 days - an extended review 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: 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 Dsm Biomedical devices

Submission Details

510(k) Number K193212 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2019
Decision Date September 10, 2020
Days to Decision 294 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
167d slower than avg
Panel avg: 127d · This submission: 294d
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 14
Devices cleared under the same product code (NPM) and FDA review panel - the closest regulatory comparables to K193212.
Wishbone HA
K211551 · Wishbone SA · Aug 2021
Porcine Mineral Collagen Composite
K202183 · Collagen Matrix, Inc. · Apr 2021
Porcine Mineral Collagen Composite Moldable
K201859 · Collagen Matrix, Inc. · Sep 2020
The Graft Bone Substitute
K191737 · Purgo Biologics, Inc. · Feb 2020
Straumann cerabone
K173594 · Institut Straumann AG · Oct 2018
The Graft Natural Bone Substitute
K173188 · Purgo Biologics, Inc. · Jul 2018