Browse hierarchy: [Dental (DE)](/submissions/DE) → [Subpart D — Prosthetic Devices](/submissions/DE/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 872.3930](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/872.3930) → NPM — Bone Grafting Material, Animal Source # NPM · Bone Grafting Material, Animal Source _Dental · 21 CFR 872.3930 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NPM ## Overview - **Product Code:** NPM - **Device Name:** Bone Grafting Material, Animal Source - **Regulation:** [21 CFR 872.3930](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/872.3930) - **Device Class:** 2 - **Review Panel:** [Dental](/submissions/DE) - **Implant:** yes ## 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. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K251786](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NPM/K251786.md) | Geistlich Bio-Oss®; Geistlich Bio-Oss Pen® | Geistlich Pharma AG | Jul 11, 2025 | SESE | | [K251613](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NPM/K251613.md) | SwissGraft X | Geistlich Pharma AG | Jun 26, 2025 | SESE | | [K242510](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NPM/K242510.md) | Geistlich Bio-Flow® | Geistlich Pharma AG | Mar 7, 2025 | SESE | | [K240133](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NPM/K240133.md) | Xenograft Bovine Bone Particulate | Collagen Solutions, LLC | Aug 16, 2024 | SESE | | [K230305](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NPM/K230305.md) | THE Graft Collagen | Purgo Biologics, Inc. | Jul 24, 2024 | SESE | | [K240661](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NPM/K240661.md) | Geistlich Bio-Oss® | Geistlich Pharma AG | Jul 12, 2024 | SESE | | [K231672](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NPM/K231672.md) | S1 | Medpark Co., Ltd. | Oct 13, 2023 | SESE | | [K221808](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NPM/K221808.md) | InterOss Collagen | Sigmagraft, Inc. | Mar 18, 2023 | SESE | | [K211551](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NPM/K211551.md) | Wishbone HA | Wishbone SA | Aug 20, 2021 | SESE | | [K202183](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NPM/K202183.md) | Porcine Mineral Collagen Composite | Collagen Matrix, Inc. | Apr 2, 2021 | SESE | | [K201859](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NPM/K201859.md) | Porcine Mineral Collagen Composite Moldable | Collagen Matrix, Inc. | Sep 11, 2020 | SESE | | [K193212](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NPM/K193212.md) | DSM Biomedical Dental Bone Graft Plus | Dsm Biomedical | Sep 10, 2020 | SESE | | [K191737](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NPM/K191737.md) | The Graft Bone Substitute | Purgo Biologics, Inc. | Feb 14, 2020 | SESE | | [K173594](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NPM/K173594.md) | Straumann cerabone | Institut Straumann AG | Oct 19, 2018 | SESE | | [K173188](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NPM/K173188.md) | The Graft Natural Bone Substitute | Purgo Biologics, Inc. | Jul 20, 2018 | SESE | | [K171008](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NPM/K171008.md) | Anorganic Bone Mineral with Collagen in Delivery Applicator | Collagen Matrix, Inc. | Oct 30, 2017 | SESE | | [K163714](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NPM/K163714.md) | OSSIX BONE | Datum Dental, Ltd. | Jul 18, 2017 | SESE | | [K170541](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NPM/K170541.md) | Anorganic Bone Mineral in Delivery Applicator | Collagen Matrix, Inc. | Jul 7, 2017 | SESE | | [K170245](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NPM/K170245.md) | DSM Biomedical Dental Bone Graft | Kensey Nash Corporation Dba Dsm Biomedical | May 16, 2017 | SESE | | [K162158](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NPM/K162158.md) | Porcine Anorganic Bone Mineral in Delivery Applicator | Collagen Matrix, Inc. | Feb 9, 2017 | SESE | ## Top Applicants - Geistlich Pharma AG — 8 clearances - Collagen Matrix, Inc. — 7 clearances - Purgo Biologics, Inc. — 3 clearances - Sigmagraft, Inc. — 2 clearances - Nibec Co., Ltd. — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NPM](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NPM) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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