NPM · Class II · 21 CFR 872.3930

FDA Product Code NPM: Bone Grafting Material, Animal Source

Animal-derived bone grafting materials provide a natural scaffold for bone regeneration. FDA product code NPM covers animal-source bone grafting materials used in dental surgery.

These xenograft materials — typically derived from bovine or porcine bone — are processed to remove organic components while preserving the mineral scaffold, providing a biocompatible matrix that supports new bone formation in extraction sockets, sinus lifts, and periodontal defects.

NPM devices are Class II medical devices, regulated under 21 CFR 872.3930 and reviewed by the FDA Dental panel.

Leading manufacturers include Geistlich Pharma AG, Collagen Matrix, Inc. and Purgo Biologics, Inc..

40
Total
40
Cleared
226d
Avg days
2004
Since
Stable submission activity - 4 submissions in the last 2 years
Review times improving: avg 115d recently vs 238d historically

FDA 510(k) Cleared Bone Grafting Material, Animal Source Devices (Product Code NPM)

40 devices
1–24 of 40
Cleared Jun 16, 2026
BOSS
K253723
Medpark Co., Ltd.
Dental · 204d
Cleared Jul 11, 2025
Geistlich Bio-Oss®
K251786
Geistlich Pharma AG
Dental · 30d
Cleared Jun 26, 2025
SwissGraft X
K251613
Geistlich Pharma AG
Dental · 30d
Cleared Mar 07, 2025
Geistlich Bio-Flow®
K242510
Geistlich Pharma AG
Dental · 196d
Cleared Aug 16, 2024
Xenograft Bovine Bone Particulate
K240133
Collagen Solutions, LLC
Dental · 211d
Cleared Jul 24, 2024
THE Graft Collagen
K230305
Purgo Biologics, Inc.
Dental · 537d
Cleared Jul 12, 2024
Geistlich Bio-Oss®
K240661
Geistlich Pharma AG
Dental · 126d
Cleared Oct 13, 2023
S1
K231672
Medpark Co., Ltd.
Dental · 127d
Cleared Mar 18, 2023
InterOss Collagen
K221808
Sigmagraft, Inc.
Dental · 269d
Cleared Aug 20, 2021
Wishbone HA
K211551
Wishbone SA
Dental · 93d
Cleared Apr 02, 2021
Porcine Mineral Collagen Composite
K202183
Collagen Matrix, Inc.
Dental · 241d
Cleared Sep 11, 2020
Porcine Mineral Collagen Composite Moldable
K201859
Collagen Matrix, Inc.
Dental · 67d
Cleared Sep 10, 2020
DSM Biomedical Dental Bone Graft Plus
K193212
Dsm Biomedical
Dental · 294d
Cleared Feb 14, 2020
The Graft Bone Substitute
K191737
Purgo Biologics, Inc.
Dental · 231d
Cleared Oct 19, 2018
Straumann cerabone
K173594
Institut Straumann AG
Dental · 332d
Cleared Jul 20, 2018
The Graft Natural Bone Substitute
K173188
Purgo Biologics, Inc.
Dental · 291d
Cleared Oct 30, 2017
Anorganic Bone Mineral with Collagen in Delivery Applicator
K171008
Collagen Matrix, Inc.
Dental · 209d
Cleared Jul 18, 2017
OSSIX BONE
K163714
Datum Dental, Ltd.
Dental · 200d
Cleared Jul 07, 2017
Anorganic Bone Mineral in Delivery Applicator
K170541
Collagen Matrix, Inc.
Dental · 134d
Cleared May 16, 2017
DSM Biomedical Dental Bone Graft
K170245
Kensey Nash Corporation Dba Dsm Biomedical
Dental · 110d
Cleared Feb 09, 2017
Porcine Anorganic Bone Mineral in Delivery Applicator
K162158
Collagen Matrix, Inc.
Dental · 191d
Cleared Aug 03, 2016
A-Oss
K151542
Hiossen, Inc.
Dental · 422d
Cleared Dec 10, 2015
Regenomer® Syringe, Regenomer® Plug, Regenomer® Block
K150079
Nibec Co., Ltd.
Dental · 329d
Cleared Nov 06, 2015
InterOss
K151209
Sigmagraft, Inc.
Dental · 184d

About Product Code NPM - Regulatory Context

510(k) Submission Activity

40 total 510(k) submissions under product code NPM since 2004, with 40 receiving FDA clearance (average review time: 226 days).

Submission volume has remained relatively stable over the observed period, with 4 submissions in the last 24 months.

FDA 510(k) Review Time - NPM Product Code

Recent submissions under NPM have taken an average of 115 days to reach a decision - down from 238 days historically, suggesting improved FDA processing for this classification.

NPM devices are reviewed by the Dental panel. Browse all Dental devices →