Nobilplast Denture Resin

K170375 · Cmp Industries, LLC · EBI · Oct 2, 2017 · Dental

Device Facts

• Record ID: K170375
• Device Name: Nobilplast Denture Resin
• Applicant: Cmp Industries, LLC
• Product Code: EBI · Dental
• Decision Date: Oct 2, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3760
• Device Class: Class 2

Intended Use

Nobilplast Denture Resin is intended for the fabrication of partial or full removable dentures, as well as occlusal splints and night guards.

Device Story

Nobilplast Denture Resin is a polyamide (nylon) resin used by dental professionals for fabricating partial or full removable dentures, occlusal splints, and night guards. The resin is supplied as granules in injectable aluminum cartridges or bulk containers. The fabrication process involves heating the cartridge in a furnace (11 minutes at 550°F/290°C), followed by injection into a dental stone mold using a manual press (3 minutes), and a 30-minute cooling period. The resulting device features semi-flexible properties, providing rigidity in thick sections to secure denture teeth and flexibility in thinner areas like clasps to accommodate undercuts. The device is used in a dental laboratory setting. It benefits patients by providing a durable, break-resistant, and comfortable prosthetic appliance.

Clinical Evidence

No clinical data. Evidence consists of bench testing and biocompatibility testing. Bench tests included density (ASTM D792), melting point (ISO 11357), hardness (ISO 868), tensile strength (ISO 527), flexural properties (ISO 178), impact strength (ISO 179/1eU, ISO 180, ASTM D256), sorption/solubility (ISO 20795), DSC (ASTM D3418), and TGA (ASTM E1311). Biocompatibility testing (cytotoxicity, irritation, sensitization) on finished partial dentures showed no issues.

Technological Characteristics

Polyamide (nylon) resin (CAS# 25587-80-8). Processing: 11 min at 550°F (290°C) furnace heating, 3 min manual injection, 30 min cooling. Material properties characterized per ISO and ASTM standards (e.g., ISO 178, ISO 527, ASTM D792). Delivery system: aluminum cartridges. Storage: 60°F–90°F.

Indications for Use

Indicated for the fabrication of partial or full removable dentures, occlusal splints, and night guards in patients requiring prosthetic dental appliances.

Regulatory Classification

Identification

A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.

Predicate Devices

• FlexStar V Resin (K072402)

Reference Devices

• High Denture Resin (K130680)
• Valplast (pre-amendment)
• TCS Unbreakable (K053060)

Submission Summary (Full Text)

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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.

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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 [phone] or [phone] 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). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm 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 (DICE) at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

# Mary S. 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

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## 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)

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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: [phone] USA Email: [e-mail] Export Email: [e-mail] 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

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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.

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| 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 |

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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.