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) → NPK — Barrier, Synthetic, Intraoral # NPK · Barrier, Synthetic, Intraoral _Dental · 21 CFR 872.3930 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NPK ## Overview - **Product Code:** NPK - **Device Name:** Barrier, Synthetic, 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 31) Showing 20 most recent of 31 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K221851](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NPK/K221851.md) | Lumina-PTFE Titanium | Criteria Industria E Comercio DE Produtos Medicinais | Dec 8, 2023 | SESE | | [K222549](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NPK/K222549.md) | OpenTex | Purgo Biologics, Inc. | May 11, 2023 | SESE | | [K211554](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NPK/K211554.md) | InnoGenic Non-resorbable Membrane | Cowellmedi Co., Ltd. | Feb 24, 2023 | SESE | | [K210797](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NPK/K210797.md) | Bio-MEM Ti Reinforced Membrane | B&Medi Co., Ltd. | Aug 18, 2022 | SESE | | [K201187](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NPK/K201187.md) | Cytoplast Titanium-Reinforced PTFE Membranes | Osteogenics Biomedical, Inc. | Jan 23, 2021 | SESE | | [K171774](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NPK/K171774.md) | RPM Reinforced PTFE Mesh | Osteogenics Biomedical, Inc. | Oct 19, 2017 | SESE | | [K160493](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NPK/K160493.md) | Cytosurg non-resorbable PTFE Membrane, 25mm x 30mm, Cytosurg non-resorbable PTFE Membrane, 12mm x 24mm | Salvin Dental Specialties | Sep 8, 2016 | SESE | | [K151344](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NPK/K151344.md) | Cytoflex Tefguard Ti-Enforced Membrane | Unicare Biomedical, Inc. | Nov 19, 2015 | SESE | | [K143327](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NPK/K143327.md) | Neoss Ti Reinforced Membrane | Neoss, Ltd. | Apr 13, 2015 | SESE | | [K132325](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NPK/K132325.md) | GUIDOR BIORESORBABLE MATRIX BARRIER | Sunstar Americas, Inc. | Oct 29, 2013 | SESE | | [K102184](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NPK/K102184.md) | MEDPOR CONTAIN CAN IMPLANT | Porex Surgical, Inc. | Jan 7, 2011 | SESE | | [K101956](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NPK/K101956.md) | STRAUMANN MEMBRAGEL | Straumann USA (On Behalf of Institut Straumann Ag) | Dec 16, 2010 | SESE | | [K091120](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NPK/K091120.md) | MEDPOR CONTAIN IMPLANT | Porex Surgical, Inc. | Mar 19, 2010 | SESE | | [K082111](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NPK/K082111.md) | STRAUMANN MEMBRAGEL | Institut Straumann AG | May 22, 2009 | SESE | | [K051267](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NPK/K051267.md) | GORE RESOLUT REGENERATIVE MATERIAL, GORE RESOLUT XT REGENERATIVE MEMBRANE, GORE OSSEOQUEST REGENERATIVE MEMBRANE | W. L. Gore & Associates, Inc. | Jun 15, 2005 | SESE | | [K033074](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NPK/K033074.md) | INION GTR BIODEGRADABLE MEMBRANE SYSTEM | Inion , Ltd. | Mar 31, 2004 | SESE | | [K990363](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NPK/K990363.md) | BIOMESH BIODEGRADABLE GTR BARRIER | Samyang Corp. | Apr 9, 1999 | SESE | | [K982865](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NPK/K982865.md) | ATRISORB BIOABSORBABLE GUIDED TISSUE REGENERATION (GTR) BARRIER KIT | Atrix Laboratories, Inc. | Sep 8, 1998 | SESE | | [K974752](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NPK/K974752.md) | IMTEC/BIOBARRIER MEMBRANE | Imtec Corp. | Mar 3, 1998 | SESE | | [K972240](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NPK/K972240.md) | IMTEC BIOBARRIER MEMBRANE | Imtec Corp. | Aug 26, 1997 | SESE | ## Top Applicants - W. L. Gore & Associates, Inc. — 5 clearances - American Custom Medical, Inc. — 3 clearances - Atrix Laboratories, Inc. — 2 clearances - Imtec Corp. — 2 clearances - Osteogenics Biomedical, Inc. — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NPK](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NPK) **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. 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