Source: http://docplayer.net/19186212-November-17-2015-nanova-biomaterials-inc-mr-andrew-ritts-senior-research-scientist-3806-mojave-ct-columbia-missouri-65202.html
Timestamp: 2019-11-22 22:53:02
Document Index: 310071050

Matched Legal Cases: ['arts 800', 'art 807', 'art 801', 'art 820', 'art 801', 'art 803', 'arts 5']

November 17, Nanova Biomaterials, Inc. Mr. Andrew Ritts Senior Research Scientist 3806 Mojave Ct Columbia, Missouri, PDF Free Download
November 17, Nanova Biomaterials, Inc. Mr. Andrew Ritts Senior Research Scientist 3806 Mojave Ct Columbia, Missouri, 65202
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1 DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration New Hampshire Avenue Document Control Center WO66-G609 Silver Spring, MD November 17, 2015 Nanova Biomaterials, Inc. Mr. Andrew Ritts Senior Research Scientist 3806 Mojave Ct Columbia, Missouri, Re: Trade/Device Name: Nanova Universal Regulation Number: 21 CFR Regulation Name: Tooth shade resin material Regulatory Class: II Product Code: EBF Dated: October 12, 2015 Received: October 19, 2015 Dear Mr. Ritts: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
2 Page 2 Mr. Andrew Ritts Please be advised that FDA s issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act s requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections of the Act); 21 CFR If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) or (301) or at its Internet address Also, please note the regulation entitled, Misbranding by reference to premarket notification (21CFR Part ). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to for the CDRH s Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) or (301) or at its Internet address Enclosure Sincerely yours, Tina Kiang -S for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
4 Nanova TM Universal Section (k) Summary 1) Submitted By: Nanova Biomaterials, Inc 3806 Mojave Ct Columbia, MO USA Contact Person: Andrew Ritts Phone: (573) Secondary Contact: Liang Chen Phone: (573) ) Establishment Registration No.: ) Date Prepared: October 12, ) Device Trade Name: Nanova TM Universal 5) Device Common Name: Universal 6) Device Classification Name: Material, Tooth Shade, Resin Product code: EBF, Reg. #: ) Classification Panel: Dental 8) Device Class: Class II 9) Predicate Devices: Nanova TM Universal is believed to be substantially equivalent to the following marketed products: Filtek Supreme Ultra Universal Restorative (K083610) product code EBF manufactured by 3M ESPE. 10) Indication for Use: Nanova Universal is indicated for use in: Direct anterior and posterior restorations (including occlusal surfaces) Core Build-ups Splinting Indirect restorations including inlays, onlays and veneers 5-1
5 Nanova TM Universal Section (k) Summary - Cont. 11) Device Description: Nanova TM Universal is a methacrylate based, visible-light activated, radiopaque, universal composite. This device is available in twist syringe and ampule packaging. Nanova TM Universal is available in a variety of tooth colored shades. Nanova TM Universal Dental Composite contains methacrylate resins, photo-initiator, and inorganic filler material. Inorganic filler loading is approximately 77% by weight. When irradiated by light, the methacrylate functionalities of the resins and surface-treated fillers undergo, in conjunction with the photo-initiator system, a light-induced polymerization to form a hard composite that is bonded to the tooth structure with a permanent dental adhesive. Nanova TM Universal formulation is based off of several FDA approved commercially available universal dental composites. The formulation was modified to improve physical properties, such as flexural strength, and handling properties. As a result of the reformulation, a biocompatibility assessment was developed for Nanova TM Universal using standard risk assessment techniques and consideration of FDA & International Standards, including ISO Parts 5 and ) Substantial Equivalence: The document, "Guidance on the CDRH Premarket Notification Review Program, 6/30/86 (K86-3)" was used to determine substantial equivalence: a) The applicant device has the same intended use as the 510(k) cleared predicate listed above. b) The technological characteristics of this product are believed to be substantially equivalent as those for the predicate device and other methacrylate based products currently on the market. Table 5.1 below shows a comparison of Nanova TM Flowable Composite and the predicate. 5-2
6 Nanova TM Universal Section (k) Summary - Cont. Table 5.1 Technical Comparison of Nanova TM Universal and Filtek Supreme Ultra Universal Restorative (K083610) Name Indications for use Composition Flexural Strength Compressive Strength Depth of Cure Water Sorption Water Solubility Packaging Nanova TM Universal Direct anterior and posterior restorations (including occlusal surfaces) Core Build-ups Splinting Indirect restorations including inlays, onlays and veneers Methacrylate resins, photoinitiators, inorganic fillers Filtek Supreme Ultra Universal Restorative (K083610) Direct anterior and posterior restorations (including occlusal surfaces) Core Build-ups Splinting Indirect restorations including inlays, onlays and veneers Methacrylate resins, photoinitiators, inorganic fillers ADA specification 27 ADA specification 27 Passes ISO 4049:2009(E) Twist Syringe and Ampule Passes ISO 4049:2009(E) Twist Syringe and Ampule Comparison Indicated for the same purposes Chemistries are similar Both above 100 MPa Both above 300 MPa Nanova Less Adsorption Nanova Less Solubility Both use twist syringe and ampules Nanova TM Universal fulfilled ISO 4049 requirements as well as FDA s guidance ucm Resin Devices. The strength and physical properties show Nanova TM Universal performs equivalently to the predicate device. ISO biocompatibility (including cytotoxicity, irritation, and sensitization) confirms the material is biocompatible. The fulfillment of ISO 4049 and ISO show Nanova Universal is substantially equivalent to the predicate. These differences do not affect the equivalence. 5-3
7 Nanova TM Universal 13) Non-Clinical Performance Testing: Non-clinical and biological testing was completed to assess its performance and biocompatibility to support substantial equivalence. The data provided in this 510(k) submission shows that the composition is biocompatible based on the biocompatibility assessment conducted based on ISO and benchtop assessment based on UCM071631, ADA specification 27, and ISO All biocompatibility tests completed were passed. Table 5.2 List of Tests Completed on Nanova TM Universal Composite Name Result Radiopacity Evaluation Color Stability Flexural Strength Compressive Strength Depth of Cure Microtensile Strength Water Sorption and Solubility Knoop Hardness Double Bond Conversion (Degree of Conversion) ISO Agarose Overlay Using L-929 Mouse Fibroblast Cells ISO Intracutaneous Irritation Test ISO Guinea Pig Maximization Sensitization Test ISO MEM Elution Using L-929 Mouse Fibroblast Cells Shelf life Surface Gloss Surface Roughness 14) Clinical Performance Testing: Clinical performance data was not included. Conclusion: Nanova Biomaterials Inc. believes that Nanova TM Universal is substantially equivalent to currently legally marketed products. It does not introduce new indications for use, has similar technological characteristics and does not introduce new potential hazards or risks. 5-4