Nobilplast Denture Resin

{0}------------------------------------------------ October 2, 2017 Image /page/0/Picture/1 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. CMP Industries LLC Devon Howe President & CEO 413 North Pearl Street Albany, New York 12207 Re: K170375 Trade/Device Name: Nobilplast Denture Resin Regulation Number: 21 CFR 872.3760 Regulation Name: Denture Relining, Repairing, Or Rebasing Resin Regulatory Class: Class II Product Code: EBI Dated: July 26, 2017 Received: July 28, 2017 Dear Devon Howe: 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. 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {1}------------------------------------------------ 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 (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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Runner -S for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) ## K170375 Device Name Nobilplast Denture Resin Indications for Use (Describe) Nobilplast Denture Resin is intended for the fabrication of partial or full removable dentures, as well as occlusal splints and night quards. | Type of Use (Select one or both, as applicable) | |-----------------------------------------------------------------------------------------------------| | <label><input checked="true" type="checkbox"/> Prescription Use (Rx = 21 CFR 801 Subpart D)</label> | | <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> | > Prescription Use (Part 21 CFR 801 Subpart D) | | Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image is a logo for Nobilium, a company that specializes in prosthetic dentistry. The logo features a blue emblem with a man's face in the center, and the word "NOBILIUM" in large, blue letters. Below the company name is the tagline "Your Partner In Prosthetic Dentistry" in smaller, blue letters. The logo is clean and professional, and it conveys a sense of trust and expertise. Division of CMP Industries LLC 413 North Pearl Street Albany, New York, 12207-1311 · USA 800 833-2343 · 518 434-3147 · Fax: 518 434-1288 USA Email: info@nobilum.com Export Email: export@nobilium.com Website: www.nobilium.com ISO 13485:2003 # K170375 Nobilplast Denture Resin 510(k) Summary September 28, 2017 Name of Submitter: Devon O. Howe Address: 413 N. Pearl St., Albany, NY 12207 Telephone number: 518-434-3147 Contact person: Devon O. Howe Date the summary was prepared by the submitter: September 28, 2017 Company: CMP Industries LLC Classification/Generic Name: denture resin Device Name: Nobilplast Denture Resin Product Code: EBI Classification: II Device Description: Nobilplast Denture Resin is a polyamide (nylon) resin available in pink and white colors. The resin granules are packaged in injectable aluminum cartridges or sold in a bulk container where users can fill empty aluminum cartridges that are sold separately. ## Indications for Use: Nobilplast Denture Resin is intended for the fabrication of partial or full removable dentures, as well as occlusal splints and night guards. Design: Nobilplast Denture Resin is designed exactly following K072402 FlexStar V. Both products share the same material type (polyamide), pigments, shading operation, packaging configuration, packaging equipment/process and quality system. Materials Used: Nobilplast Denture Resin is a polyamide (nylon) that is nearly identical to K072402 FlexStar V. Nobilplast Denture Resin is part of a delivery system that includes aluminum cartridges. Performance Testing: Nobilplast Denture Resin was subjected to several bench tests to characterize its properties including: Density per ASTM D792, Melting Point per ISO 11357, Hardness Shore per ISO 868, Tensile per ISO 527, Ultimate Flexural and {4}------------------------------------------------ Flexural Modulus per ISO 178, Charpy Impact ISO 179/1eU, Sorption & Solubility per ISO 20795, DSC Analysis per ASTM D3418, TGA Analysis per ASTM E1311, Melt Flow Rate Analysis, Izod Impact Strength per ISO 180 or ASTM D256. Primary Predicate Device: K072402 FlexStar V Resin Reference Devices: K130680 High Denture Resin, (pre-amendment) Valplast, K053060 TCS Unbreakable Biocompatibility: Nobilplast Denture Resin was used to make partial dentures in final finished form as test articles that were used in biological testing as suggested by FDA Guidance: Cytotoxicity, Irritation and Sensitization. The testing results indicate no biocompatibility issues exist for Nobilplast Denture Resin. Shelf Life: Nobilplast Denture Resin has a 5-year shelf-life demonstrated by real-time packaging study on the nearly identical product: FlexStar V. Details are in Section 11, Attachment 1. Substantial Equivalence: The polyamide resin of FLEXSTAR V, Dentsoll Rezen NF, TCS Unbreakable and Valplast are very similar in formulations, presentation and colors to Nobilplast Denture Resin. The polymer used for FLEXSTAR V (primary predicate) is the same brand name (Rilsan) as used for Nobilplast and they both share the same pigments and packaging systems and configurations. FLEXSTAR V and Nobilplast Denture Resin have the same intended use. Dentsoll Rezen NF, TCS Unbreakable and Valplast and FlexStar have the same intended use as Nobilplast. The bench and biological tests on Nobilplast Denture Resin demonstrate that safety and effectiveness is as good as the predicate devices. Page 2 of 5 {5}------------------------------------------------ | Property | | Primary Predicate | Reference Device | Reference Device | Reference Device | |-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Property | Nobilplast Denture Resin | FLEXSTAR V<br>(K072402) | TCS Unbreakable<br>(K053060) | DENTSOLL Rezen NF<br>(K130680) | VALPLAST (9008371)<br>Pre-amendment | | Intended<br>Use | Nobilplast Denture Resin<br>is used for the fabrication<br>of partial or full removable<br>dentures, as well as<br>occlusal splints and night<br>guards.<br><br>Note: The likelihood that<br>anyone would use<br>Nobilplast Denture Resin<br>for <i>relining</i> , <i>repairing</i> , and<br><i>rebasing</i> dentures is<br>extremely low, which is<br>why it was omitted from<br>the indication for use.<br>There are many other<br>ways to perform these<br>procedures which are<br>faster, easier, cheaper<br>and more effective.<br><br>Note: Occlusal splint is<br>the same as a "bite plate"<br>as shown in DENTSOLL.<br><br>Note: "personal trays" is<br>the same as an<br>impression tray. No one<br>will use this type of<br>material for this<br>application, which why it<br>was omitted from<br>Nobilplast Denture Resin. | FLEXSTAR V is<br>used for the<br>fabrication of partial<br>or full removable<br>dentures, as well as<br>occlusal splints and<br>night guards. | TCS® Unbreakable is a<br>break resistant material<br>used in the fabrication<br>and repair of base<br>plates for removeable<br>dental prosthetic<br>appliances where<br>superior flexibility and<br>patient comfort for the<br>lifetime of the prosthetic<br>are significant concerns.<br>This includes, but not to<br>be limited to, full and<br>partial dentures,<br>orthodontic devices,<br>occlusal splints,<br>and night guards. | Intended for<br>manufacturing, <i>relining</i> ,<br><i>repairing</i> , and <i>rebasing</i> of<br>partial or full<br>removable dentures,<br>dental plates, <i>bite plates</i> ,<br><i>personal trays</i> , appliances,<br>occlusal splints and night<br>guards. | Valplast is used for the<br>fabrication of partial or<br>full removable dentures,<br>Cosmetic Gum Veneers,<br>Nightguards and<br>Occlusal Splints, Onlays.<br><br>Valplast applications can<br>be found here:<br>https://www.valplast.com/<br>special-applications-1/ | | Property | Nobilplast Denture Resin | Primary Predicate | Reference Device | Reference Device | Reference Device | | Type and Class | Type III, Class 1 | FLEXSTAR V (K072402) | TCS Unbreakable (K053060) | DENTSOLL Rezen NF (K130680) | VALPLAST (pre-amendment) | | Chemical Family | Polyamide | Polyamide | Polyamide | Polyamide | Polyamide | | CAS Number | CAS# 25587-80-8 | CAS# 25587-80-8 | unknown | 25038-97-5 | unknown | | Material used to invest | Dental Stone | Dental Stone | Dental Stone | Dental Stone | Dental Stone | | Storage Temperature | 60°F – 90°F | 60°F - 90°F | Store in a dry, cool and well-ventilated place | 60°F - 90°F | Store in cool dry area | | Dosage | 1 cartridge | 1 cartridge | 1 cartridge | 1 cartridge | 1 cartridge | | Processing Time/Temperature | 11 minutes @ 550°F (290°C) (furnace heats one cartridge at a time) | 11 minutes @ 550°F (290°C) (furnace heats one cartridge at a time) | 11 minutes @ 550°F (288°C) (furnace heats one cartridge at a time) | 25 minutes @ (260°C) (furnace heats 6 cartridges at a time) | 11 minutes @ 550°F (290°C) (furnace heats one cartridge at a time) | | Injection Time | 3 minutes (using manual press) | 3 minutes (using manual press) | 3 minutes (using manual press) | 5 minutes (using air-powered press) | 3 minutes (using manual press) | | Cool Time | 30 minutes | 30 minutes | 30 minutes | 30 minutes | 30 minutes | | Physical Properties | Partial denture is semi-flexible: Thick sections are rigid to hold denture teeth into place while thinner areas, such as clasps, are slightly flexible to accommodate undercuts on abutment teeth. | Same as Nobilplast Denture Resin | Physical properties have not been bench tested. | Same as Nobilplast Denture Resin | Same as Nobilplast Denture Resin | {6}------------------------------------------------ {7}------------------------------------------------ Conclusion: Nobilplast Denture Resin is substantially equivalent to FLEXSTAR V and TCS Unbreakable and Valplast. All five products have indications for use that are primarily for partial and full dentures. While Rezen NF and Valplast indicate alternative applications, in practice, they are not used for these alternative applications with any regularity. All five are made from the same type of polymer and have similar injection and cooling times. They are all Type III class I denture materials. The processing temperatures are the same between Nobilplast Denture Resin and TCS Unbreakable and FLEXSTAR V and Valplast and similar to Dentsoll Rezen NF. Nobilplast Denture Resin is substantially equivalent as demonstrated by biological testing conducted on finished form partial dentures.