NPL · Barrier, Animal Source, Intraoral
Dental · 21 CFR 872.3930 · Class 2
Overview
| Product Code | NPL |
|---|---|
| Device Name | Barrier, Animal Source, Intraoral |
| Regulation | 21 CFR 872.3930 |
| Device Class | Class 2 |
| Review Panel | Dental |
| 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 | Jason membrane | Botiss Biomaterials GmbH | Dec 12, 2025 | SESE |
| K250512 | Augmented Gingival Matrix | Neo Modulus (Suzhou) Medical Sci-Tech Co., Ltd. | Dec 5, 2025 | SESE |
| K252253 | Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-Gide® | Geistlich Pharma AG | Nov 25, 2025 | SESE |
| K251062 | 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 | SwissMembrane X; SwissMembrane X Socket | Geistlich Pharma AG | Apr 15, 2025 | SESE |
| K233203 | Soft Tissue Augmentation Resorbable Matrix | Collagen Matrix, Inc. | May 1, 2024 | SESE |
| K231513 | Oral Matrix | Beijing Biosis Healing Biolog Ical Technology Co., Ltd. | Feb 16, 2024 | SESE |
| K231305 | Endoform Dental Membrane | Aroa Biosurgery , Ltd. | Jan 23, 2024 | SESE |
| K230091 | THE Cover | Purgo Biologics, Inc. | Oct 6, 2023 | SESE |
| K223912 | InterCollagen® Guide | Sigmagraft, Inc. | Aug 17, 2023 | SESE |
| K213904 | Kerecis Oral | Kerecis | Sep 30, 2022 | SESE |
| K212509 | OSSIX Breeze | Datum Dental, Ltd. | Jul 18, 2022 | SESE |
| K212463 | 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 | Geistlich Mucograft®, Geistlich Mucograft® Seal | Geistlich Pharma AG | Mar 3, 2021 | SESE |
| K201241 | Striate+ | Orthocell, Ltd. | Jan 11, 2021 | SESE |
| K192612 | Kerecis Gingiva Graft | Kerecis Limited | Nov 13, 2020 | SESE |
| K200623 | OssGuide | Sk Bioland Co., Ltd. | Oct 2, 2020 | SESE |
| K192042 | 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 | Straumann Jason Membrane | Institut Straumann AG | Jul 9, 2018 | SESE |
| K171050 | 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
