Cleared Traditional

The Graft Bone Substitute (K191737) - FDA 510(k) Clearance

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

K191737 · Purgo Biologics, Inc. · Dental device
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Feb 2020
Decision
231d
Days
Class 2
Risk

K191737 is an FDA 510(k) clearance for the The Graft Bone Substitute. Classified as Bone Grafting Material, Animal Source (product code NPM), Class II - Special Controls.

Submitted by Purgo Biologics, Inc. (Seongnam-Si, KR). The FDA issued a Cleared decision on February 14, 2020 after a review of 231 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 Purgo Biologics, Inc. devices

Submission Details

510(k) Number K191737 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 2019
Decision Date February 14, 2020
Days to Decision 231 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
104d slower than avg
Panel avg: 127d · This submission: 231d
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 K191737.
Porcine Mineral Collagen Composite
K202183 · Collagen Matrix, Inc. · Apr 2021
Porcine Mineral Collagen Composite Moldable
K201859 · Collagen Matrix, Inc. · Sep 2020
DSM Biomedical Dental Bone Graft Plus
K193212 · Dsm Biomedical · Sep 2020
Straumann cerabone
K173594 · Institut Straumann AG · Oct 2018
The Graft Natural Bone Substitute
K173188 · Purgo Biologics, Inc. · Jul 2018