NPK · Barrier, Synthetic, Intraoral
Dental · 21 CFR 872.3930 · Class 2
Overview
| Product Code | NPK |
|---|---|
| Device Name | Barrier, Synthetic, 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.
Cleared Devices (31)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K221851 | Lumina-PTFE Titanium | Criteria Industria E Comercio DE Produtos Medicinais | Dec 8, 2023 | SESE |
| K222549 | OpenTex | Purgo Biologics, Inc. | May 11, 2023 | SESE |
| K211554 | InnoGenic Non-resorbable Membrane | Cowellmedi Co., Ltd. | Feb 24, 2023 | SESE |
| K210797 | Bio-MEM Ti Reinforced Membrane | B&Medi Co., Ltd. | Aug 18, 2022 | SESE |
| K201187 | Cytoplast Titanium-Reinforced PTFE Membranes | Osteogenics Biomedical, Inc. | Jan 23, 2021 | SESE |
| K171774 | RPM Reinforced PTFE Mesh | Osteogenics Biomedical, Inc. | Oct 19, 2017 | SESE |
| K160493 | Cytosurg non-resorbable PTFE Membrane, 25mm x 30mm, Cytosurg non-resorbable PTFE Membrane, 12mm x 24mm | Salvin Dental Specialties | Sep 8, 2016 | SESE |
| K151344 | Cytoflex Tefguard Ti-Enforced Membrane | Unicare Biomedical, Inc. | Nov 19, 2015 | SESE |
| K143327 | Neoss Ti Reinforced Membrane | Neoss, Ltd. | Apr 13, 2015 | SESE |
| K132325 | GUIDOR BIORESORBABLE MATRIX BARRIER | Sunstar Americas, Inc. | Oct 29, 2013 | SESE |
| K102184 | MEDPOR CONTAIN CAN IMPLANT | Porex Surgical, Inc. | Jan 7, 2011 | SESE |
| K101956 | STRAUMANN MEMBRAGEL | Straumann USA (On Behalf of Institut Straumann Ag) | Dec 16, 2010 | SESE |
| K091120 | MEDPOR CONTAIN IMPLANT | Porex Surgical, Inc. | Mar 19, 2010 | SESE |
| K082111 | STRAUMANN MEMBRAGEL | Institut Straumann AG | May 22, 2009 | SESE |
| K051267 | GORE RESOLUT REGENERATIVE MATERIAL, GORE RESOLUT XT REGENERATIVE MEMBRANE, GORE OSSEOQUEST REGENERATIVE MEMBRANE | W. L. Gore & Associates, Inc. | Jun 15, 2005 | SESE |
| K033074 | INION GTR BIODEGRADABLE MEMBRANE SYSTEM | Inion , Ltd. | Mar 31, 2004 | SESE |
| K990363 | BIOMESH BIODEGRADABLE GTR BARRIER | Samyang Corp. | Apr 9, 1999 | SESE |
| K982865 | ATRISORB BIOABSORBABLE GUIDED TISSUE REGENERATION (GTR) BARRIER KIT | Atrix Laboratories, Inc. | Sep 8, 1998 | SESE |
| K974752 | IMTEC/BIOBARRIER MEMBRANE | Imtec Corp. | Mar 3, 1998 | SESE |
| K972240 | IMTEC BIOBARRIER MEMBRANE | Imtec Corp. | Aug 26, 1997 | SESE |
| K960724 | BIO-GIDE RESORBABLE BILAYER MEMBRANE | Geistlich-Pharma | Jun 11, 1997 | SESE |
| K965205 | TEFGEN - LS | American Custom Medical, Inc. | Apr 30, 1997 | SESE |
| K964656 | TEFGEN GUIDED TISSUE MEMBRANE | American Custom Medical, Inc. | Feb 10, 1997 | SESE |
| K955646 | VICRYL PERIDONTAL MESH | ETHICON, Inc. | May 20, 1996 | SESE |
| K960292 | GORE-TEX REGENERATIVE MATERIAL TITANIUM REINFORCED CONFIGURATIONS | W. L. Gore & Associates, Inc. | Apr 15, 1996 | SESE |
| K955838 | ATRISORB BIOABSORBABLE GUIDED TISSUE REGNERATION(GTR) | Atrix Laboratories, Inc. | Mar 21, 1996 | SESE |
| K935137 | TEFGEN-FD | American Custom Medical, Inc. | Aug 15, 1994 | SESE |
| K922627 | GORE-TEX REGENERATIVE MATERIAL | W. L. Gore & Associates, Inc. | Jun 10, 1994 | SESE |
| K933541 | GORE-TEX PERIODONTAL MATERIAL - TITANIUM REINFORCED CONFIGURATIONS | W. L. Gore & Associates, Inc. | Nov 30, 1993 | SESE |
| K912724 | GUIDOR(TM) | Procordia Oratech AB | May 13, 1993 | SN |
| K854299 | GORE-TEX PERIODONTAL MATERIAL | W. L. Gore & Associates, Inc. | May 19, 1986 | SESE |
Top Applicants
- W. L. Gore & Associates, Inc. — 5 clearances
- American Custom Medical, Inc. — 3 clearances
- Porex Surgical, Inc. — 2 clearances
- Osteogenics Biomedical, Inc. — 2 clearances
- Imtec Corp. — 2 clearances
