NPM · Bone Grafting Material, Animal Source

Dental · 21 CFR 872.3930 · Class 2

Overview

Product CodeNPM
Device NameBone Grafting Material, Animal Source
Regulation21 CFR 872.3930
Device ClassClass 2
Review PanelDental
ImplantYes

Identification

Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.

Classification Rationale

(1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.) (2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval.

Special Controls

*Classification.* (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval. (c) *Date premarket approval application (PMA) or notice of product development protocol (PDP) is required.* Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

Recent Cleared Devices (20 of 39)

Showing 20 most recent of 39 cleared devices.

RecordDevice NameApplicantDecision DateDecision
K251786Geistlich Bio-Oss®; Geistlich Bio-Oss Pen®Geistlich Pharma AGJul 11, 2025SESE
K251613SwissGraft XGeistlich Pharma AGJun 26, 2025SESE
K242510Geistlich Bio-Flow®Geistlich Pharma AGMar 7, 2025SESE
K240133Xenograft Bovine Bone ParticulateCollagen Solutions, LLCAug 16, 2024SESE
K230305THE Graft CollagenPurgo Biologics, Inc.Jul 24, 2024SESE
K240661Geistlich Bio-Oss®Geistlich Pharma AGJul 12, 2024SESE
K231672S1Medpark Co., Ltd.Oct 13, 2023SESE
K221808InterOss CollagenSigmagraft, Inc.Mar 18, 2023SESE
K211551Wishbone HAWishbone SAAug 20, 2021SESE
K202183Porcine Mineral Collagen CompositeCollagen Matrix, Inc.Apr 2, 2021SESE
K201859Porcine Mineral Collagen Composite MoldableCollagen Matrix, Inc.Sep 11, 2020SESE
K193212DSM Biomedical Dental Bone Graft PlusDsm BiomedicalSep 10, 2020SESE
K191737The Graft Bone SubstitutePurgo Biologics, Inc.Feb 14, 2020SESE
K173594Straumann ceraboneInstitut Straumann AGOct 19, 2018SESE
K173188The Graft Natural Bone SubstitutePurgo Biologics, Inc.Jul 20, 2018SESE
K171008Anorganic Bone Mineral with Collagen in Delivery ApplicatorCollagen Matrix, Inc.Oct 30, 2017SESE
K163714OSSIX BONEDatum Dental, Ltd.Jul 18, 2017SESE
K170541Anorganic Bone Mineral in Delivery ApplicatorCollagen Matrix, Inc.Jul 7, 2017SESE
K170245DSM Biomedical Dental Bone GraftKensey Nash Corporation Dba Dsm BiomedicalMay 16, 2017SESE
K162158Porcine Anorganic Bone Mineral in Delivery ApplicatorCollagen Matrix, Inc.Feb 9, 2017SESE

Top Applicants

Innolitics

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