Table 2.
List of NMDs approved by FDA for marketing through the 510(k) process. Extracted from 510(k) Premarket Notification database https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm (keyword: nano)
| Medical application/specialty | Device/trade name | Applicant | Date of approval | Nanomaterial | Indication |
|---|---|---|---|---|---|
| Anesthesiology | UniPlex NanoLine cannula, PlexoLong-NanoLine set, StimuLong-NanoLine Set | Pajunk GmbH | 01/12/2006 | Nanoparticle-enhanced surface layer | Anesthesia conduction kits for temporary anesthetic delivery to peripheral nerve bundles during regional anesthesia |
| SonoLong Sono, Curl Sono, NanoLine® | PAJUNK GmbH Medizintechnologie | 03/01/2012 | Polymer nanocoating | Anesthesia conduction kits for delivery of continuous conduction anesthesia and/or analgesia of peripheral nerves | |
| Clinical chemistry | Nanosep™ N10 | Intercept, Ltd | 04/26/1994 | Nanoporous structures membrane | Clinical sample concentrator, for the concentration and purification of biological samples such as peptides, proteins, oligonucleotides, DNA, and RNA |
| Nano-Check™ AMI 3 in 1 Cardiac Disease Test | Nano-Ditech Corporation | 03/02/2006 | Colloidal Au NPs | Immunoassay method, a one-step lateral flowimmuno chromatography assay for the qualitative determination of three cardiac markers simultaneously in serum and heparin plasma | |
| Nano-Check™ AMI 2 in 1 Cardiac Marker, cTnI and Myoglobin | Nano-Ditech Corporation | 10/20/2010 | Colloidal Au NPs | Immunoassay method, to provide rapid and reliable results in diagnosing acute myocardial infarction (heart attack) by measuring the levels of cTnI and Myoglobin in the blood | |
| Nano-Check™ AMI cTnI Cardiac Marker Test | Nano-Ditech Corporation | 10/20/2010 | Colloidal Au NPs | A rapid immunoassay for the qualitative determination of cardiac troponin I (cTnI) in human serum and plasma specimens at cut off, as an aid in the diagnosis of Acute Myocardial Infarction (AMI) | |
| Dental | NanoTite PREVAIL, Certain, Parallel Walled, Tapered, External Hex | BIomet 3i, Inc | 01/31/2008 | Osseotite® nanoscale surface and nanocrystalline deposition of calcium phosphate | A root-form endosseous implant, for surgical placement in the jaw to support prosthetic attachments for single-tooth restorations, partially or fully edentulous spans, bridgework, and overdentures |
| Renamel® NANO™ + plus | Cosmedent, Inc | 02/24/2017 | Multifunctional acrylic monomers and silicaceous nanofillers | Tooth shade resin material, designed for Class I-V dental restorations, direct veneering of anterior teeth, splinting, and the repair of composite or ceramic restorations | |
| Nano composite | Cosmedent, Inc | 04/16/2007 | Light-cure nanocomposite | Tooth shade resin material, possesses the physical and mechanical properties to function in the oral cavity, mimicking the esthetic qualities of natural teeth | |
| DMRC NanoFlow; DMRC Nanocomposite; ebond; sure etch gel; sure etch liquid | Danville Materials, Inc | 09/25/2012 | Light-cure NPs | DMRC NanoFlow, a flowable composite for small cavities, repairs, linings, sealants, and marginal repairs; DMRC NanoComposite, a universal composite for direct and indirect restorations; eBond, a bonding agent to enhance adhesion between composites and tooth structure; Sure Etch Gel and Sure Etch Liquid, both used to prepare tooth surfaces for improved bonding by creating micropores | |
| Prime & Bond® NT™ Dual Cure Nano-Technology Universal Dental Adhesive System | Dentsply International, Inc | 02/23/2005 | Nanofiller | Tooth bonding agent for bonding all indirect restorations, including metal, ceramic, and composite crowns, inlays, onlays, veneers, bridge retainers, and endodontic posts to enamel and dentin without light | |
| Nanocomposite Restorative Kit | DMG USA, Inc | 05/30/2008 | Light-cure nanocomposite | Tooth shade resin material, designed for restorative procedures to repair and restore the function and aesthetics of teeth affected by cavities or other forms of dental damage | |
| NanoCeram-Bright | DMP, Ltd | 11/19/2010 | Light-cure nano-hybrid composite | Resin material for anterior and posterior restorations, cervical caries, root erosion, wedge-shaped defects, veneering discoloured anterior teeth, splinting mobile teeth, and repairing composite and ceramic veneers | |
| Nano Varnish, Plaquit, Lightpaint on Surface | Dreve Dentamid GmbH | 04/05/2018 | Light-cure NPs | Dental sealing lacquer for coating resin temporaries | |
| NanotiteTM Dental Implants | Implant Innovations, Inc | 02/22/2007 | Calcium phosphate nanocrystal | Dental implants with nanoscale calcium phosphate crystals on the surface | |
| Series of Nanova products for dental use | Nanova Biomaterials Inc | 01/16/2018 etc.* | Hydroxyapatite nanofiber | Tooth bonding agents; sealant, pit and fissure, conditioner; tooth shade resin materials | |
| Nano-TiCrown™ | Nano-Write Corporation | 06/11/2003 | Nanostructured titanium/titanium nitride material | Base metal alloy for making single-unit porcelain-fused-to-metal (PFM) prosthetics and custom dental prosthetics, such as porcelain-to-metal veneers | |
| Dimer Acid Derived Nano-hybrid Composite Restorative Material | Novocol, Inc | 09/13/2007 | Dimer acid derived nanohybrid composite | Tooth shade resin material, for class I, II, III, IV and V cavity classes | |
| NanoGen® | Orthogen, Llc | 05/06/2011 | Nanocrystalline calcium sulfate | Bone grafting material for bone regeneration, used alone, mixed with other bone filling agents to prevent particle migration, or as a resorbable barrier over other graft materials | |
| Pac-Dent Ceramic Nanohybrid Resin | Pac-Dent, Inc | 07/26/2021 | Ceramic nanohybrid | Tooth shade resin material, for fabricating permanent restorations such as inlays, onlays, veneers and full crownrestorations | |
| Nano-Bond II Adhesive System | Pentron Clinical Technologies | 08/10/2007 | Light-cure nanocomposite | Resin tooth bonding agent | |
| Sculpture® Plus Nano-Hybrid Composite | Pentron Laboratory Technologies | 01/17/2003 | Nanohybrid composite | Dental restorative material used to restore carious lesions, structural defects, or lost tooth structure | |
| CalApex Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, Zical Ultra Powder/Liquid | Prevest Denpro, Ltd | 05/23/2022 | Ag NPs | Antibacterial root canal sealer fortified with nanosilver used in conjunction with gutta-percha for effective sealing root canals of permanent teeth | |
| Camouflage™ NanoHybrid Composite (Universal and Flowable) | Prismatik Dentalcraft, Inc | 06/04/2014 | Ceramic-filled nanohybrid resin composite material | Tooth shade resin material for Class I-VI cavities in anterior and posterior teeth, suitable for direct restorations, inlays, and onlays | |
| Capo Hybrid, Capo Slow Flow, Capo Flow, Capo Natural, Capo Universal, Nano Paq, Nano Paq Flow | Schütz Dental GmbH | 10/24/2016 | Light-cure nanocomposite | Tooth shade resin material for direct and indirect restorations, fissure sealing on premolars and molars, stump buildup, and shape and colour correction | |
| General & plastic surgery | Series of LigaSure™ products | Covidien | 03/23/2021 etc.* | Nonstick nanocoating | Electrosurgical cutting and coagulation device and accessories, for open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics |
| Medline ReNewal Reprocessed LigaSure Exact Dissector, Nano-coated (LF2019) | Surgical Instrument Service And Savings, Inc | 04/29/2024 | Nanocoating to reduce tissue sticking | Electrosurgical cutting and coagulation device and accessories | |
| Immunology | Nanopia Wide Range C-Reactive ProTein (CRP) Reagent Kit | Clinical Data, Inc | 02/09/2006 | Antibody-coated latex particles | Quantitative latex agglutination immunoassay for measuring C-Reactive Protein (CRP) in serum or plasma, used to evaluate infection, tissue injury, and inflammatory disorders alongside a complete clinical evaluation |
| Microbiology | Nano-Check™ COVID-19 Antigen Test | Nano-Ditech Corporation | 01/23/2024 | Au NPs | Simple point-of-care device, used as an immunochromatographic lateral flow assay for detection of SARS-CoV-2 nucleo protein antigens in human anterior nasal swab specimens |
| Neurology | Series of Titan NanoLOCK products for neurology | Medtronic Sofamor Danek USA, Inc | 09/29/2022 etc.* | Titanium nanoscale featured surface | Stereotaxic Instruments, to be used during preparation and placement of Medtronic implants during spinal surgery to assist in precisely locating anatomical structures in either open, or minimally invasive, procedures |
| Orthopedic | Ascend VBR System, Ascend NanoTec VBR System | Alphatec Spine, Inc | 10/06/2023 | Hydroxyapatite nanocoating | Spinal intervertebral body fixation orthosis to replace a collapsed, damaged, or unstable vertebral body or for reconstructive decompression of the spinal cord and neural tissues in degenerative disorders |
| Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody System | Alphatec Spine, Inc | 07/13/2023 | Hydroxyapatite nanocoating | Intervertebral body fusion device for spinal fusion from L1 to S1 in skeletally mature patients, treating symptomatic degenerative disc disease (DDD), degenerative spondylolisthesis, and/or spinal stenosis at one or two adjacent levels | |
| Series of IdentiTi Porous Ti Interbody Systems | Alphatec Spine, Inc | 02/22/2024 etc.* | Hydroxyapatite nanocoating | Intervertebral body fusion devices for treating DDD and spinal instability in skeletally mature patients | |
| nanOss® Bone Void Filler | Angstrom Medica, Inc | 02/03/2005 | Hydroxyapatite nanocrystal | Resorbable calcium salt bone void filler device for non-structural bony voids or gaps in the extremities, spine, and pelvis | |
| Series of NanoBone® products | Artoss GmbH | 04/23/2019 etc.* | Nanocrystalline osteoconductive hydroxyapatite | Resorbable calcium salt bone void fillers device for bony voids or gaps in the extremities, posterolateral spine, and pelvis | |
| EMPOWR Porous Femur with HAnano SurfaceTM | Encore Medical, L.P | 03/30/2021 | Hydroxyapatite nanocoating | Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis for total knee arthroplasty, treating arthritis, avascular necrosis, joint configuration loss, deformities, fractures, and for salvage of failed surgeries | |
| NanoHive Medical Lumbar Interbody System | Ian Helmar | 07/12/2023 | Soft Titanium® lattice nanotextured surface | Intervertebral body fusion device for use in skeletally mature patients with DDD at one or two contiguous levels from L2 to S1 | |
| Series of Titan NanoLOCK products for orthopedic | Medtronic Sofamor Danek USA, Inc | 10/06/2022 etc.* | Titanium nanoscale featured surface | Intervertebral body fusion device for spinal fusion in skeletally mature patients with symptomatic DDD, degenerative spondylolisthesis, and/or spinal stenosis at one or two levels from L2 to S1 | |
| Series of Nanova products for orthopedic use | Nanova Biomaterials Inc | 05/05/2017 etc.* | Hydroxyapatite nanofiber | Metallic bone fixation appliances and accessories for securing soft tissue or bone-tendon-bone grafts during cruciate ligament reconstruction surgeries of the knee | |
| Series of Nanovis systems | Nanovis, Llc | 06/02/2023 etc.* | Bio-ceramic nanotube surface | Intervertebral body fusion devices for immobilising and stabilising spinal segments as an adjunct to fusion in patients with DDD, spinal stenosis, spondylolisthesis, spinal deformities, trauma, tumours, pseudarthrosis, and failed fusions | |
| Series of nanOss™ products | Pioneer Surgical Technology, Inc | 10/17/2014 etc.* | Nano-structured hydroxyapatite | Bone void fillers | |
| Series of SeaSpine Systems | SeaSpine Orthopedics Corporation | 07/07/2021 etc.* | Titanium nanoscale featured surface | Intervertebral body fusion devices | |
| OsteoFlo® NanoPutty®-Quadphasic Synthetic Bone Graft | SurGenTec, Llc | 08/14/2020 | Hydroxyapatite NPs | Resorbable calcium salt bone void filler device | |
| Tyber Medical BioTy® Nanotopography Trauma Screw | Tyber Medical, Llc |
06/20/2017 11/16/2016 |
Nanoscale featured surface | Metallic bone fixation fastener for bone reconstruction, osteotomy, arthrodesis, and joint fusion | |
| Radiology | DRX-Revolution Nano Mobile X-ray System | Carestream Health, Inc | 02/05/2018 etc.* | Carbon nanotube | Diagnostic mobile x-ray system with digital radiography (DR) technology, featuring a self-contained x-ray generator, image receptor(s), imaging display, and software for acquiring diagnostic images outside a standard x-ray room |
| Nanox.ARC | Nanox Imaging, Ltd | 04/28/2023 | Nano-cones field on a silicon chip | Tomographic X-ray system for producing images of the human musculoskeletal system from a single sweep, as an adjunct to conventional radiography for adult patients | |
| Nanox Cart X-ray System | Nanox Imaging, Ltd | 04/01/2021 | Nano-cones field on a silicon chip | Mobile X-ray system for radiographic examinations of hands, wrists, and fingers in adult patients, designed for use when transporting the patient to fixed equipment is not feasible | |
| Nanor® and Efficast/Nanor Hybrid Thermoplastic Materials | Orfit Industries N.V | 09/26/2013 | Hybrid thermoplastic NPs | Medical charged-particle radiation therapy system for retaining and reproducing a patient's position during radiation therapy | |
| Toxicology | Nano-Check™ DAT 5 Multi Drug Screening Test | Nano-Ditech Corporation | 05/15/2005 | Colloidal Au NPs | Qualitative immunoassay: a one-step, type II competitive immunochromatographic assay for detecting cannabinoids, opiates, benzoylecgonine, methamphetamine, phencyclidine, and their metabolites in human urine |
*Disc.: Due to the complex regulatory process and need for continuous improvement, medical devices often undergo multiple revisions and approvals, resulting in several approval dates throughout their life cycle