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) → NPL — Barrier, Animal Source, Intraoral # NPL · Barrier, Animal Source, Intraoral _Dental · 21 CFR 872.3930 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NPL ## Overview - **Product Code:** NPL - **Device Name:** Barrier, Animal Source, Intraoral - **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 57) Showing 20 most recent of 57 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K242817](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NPL/K242817.md) | Jason membrane | Botiss Biomaterials GmbH | Dec 12, 2025 | SESE | | [K250512](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NPL/K250512.md) | Augmented Gingival Matrix | Neo Modulus (Suzhou) Medical Sci-Tech Co., Ltd. | Dec 5, 2025 | SESE | | [K252253](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NPL/K252253.md) | Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-Gide® | Geistlich Pharma AG | Nov 25, 2025 | SESE | | [K251062](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NPL/K251062.md) | Geistlich Bio-Gide; Geistlich Bio-Gide® Shape; Geistlich Bio-Gide® Compressed; Geistlich Bio-Gide® Forte; Geistlich Bio-Gide® Perio; Geistlich Combi-Kit Collagen®; Geistlich Perio-System Combi Pack | Geistlich Pharma AG | Aug 14, 2025 | SESE | | [K250833](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NPL/K250833.md) | SwissMembrane X; SwissMembrane X Socket | Geistlich Pharma AG | Apr 15, 2025 | SESE | | [K233203](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NPL/K233203.md) | Soft Tissue Augmentation Resorbable Matrix | Collagen Matrix, Inc. | May 1, 2024 | SESE | | [K231513](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NPL/K231513.md) | Oral Matrix | Beijing Biosis Healing Biolog Ical Technology Co., Ltd. | Feb 16, 2024 | SESE | | [K231305](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NPL/K231305.md) | Endoform Dental Membrane | Aroa Biosurgery , Ltd. | Jan 23, 2024 | SESE | | [K230091](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NPL/K230091.md) | THE Cover | Purgo Biologics, Inc. | Oct 6, 2023 | SESE | | [K223912](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NPL/K223912.md) | InterCollagen® Guide | Sigmagraft, Inc. | Aug 17, 2023 | SESE | | [K213904](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NPL/K213904.md) | Kerecis Oral | Kerecis | Sep 30, 2022 | SESE | | [K212509](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NPL/K212509.md) | OSSIX Breeze | Datum Dental, Ltd. | Jul 18, 2022 | SESE | | [K212463](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NPL/K212463.md) | Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, Geistlich Bio-Gide Perio, Geistlich Combi-Kit Collagen and Geistlich Perio-System Combi Pack | Geistlich Pharma AG | Apr 5, 2022 | SESE | | [K210280](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NPL/K210280.md) | Geistlich Mucograft®, Geistlich Mucograft® Seal | Geistlich Pharma AG | Mar 3, 2021 | SESE | | [K201241](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NPL/K201241.md) | Striate+™ | Orthocell, Ltd. | Jan 11, 2021 | SESE | | [K192612](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NPL/K192612.md) | Kerecis Gingiva Graft | Kerecis Limited | Nov 13, 2020 | SESE | | [K200623](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NPL/K200623.md) | OssGuide | Sk Bioland Co., Ltd. | Oct 2, 2020 | SESE | | [K192042](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NPL/K192042.md) | Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, Geistlich Bio-Gide Perio, Geistlich Combi-Kit Collagen, Geistlich Perio-System Combi-Pack, Geistlich Mucograft and Geistlich Mucograft Seal | Geistlich Pharma AG | Aug 29, 2019 | SESE | | [K173562](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NPL/K173562.md) | Straumann Jason Membrane | Institut Straumann AG | Jul 9, 2018 | SESE | | [K171050](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NPL/K171050.md) | Geistlich Fibro-Gide | Geistlich Pharma AG | Nov 9, 2017 | SESE | ## Top Applicants - Collagen Matrix, Inc. — 10 clearances - Geistlich Pharma AG — 9 clearances - Ed. Geistlich Soehne AG Fuer Chemische Industrie — 5 clearances - Datum Dental, Ltd. — 3 clearances - Cook Biotech, Inc. — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NPL](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NPL) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com