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.

AI/ML Overview

The FDA 510(k) summary for Nobilplast Denture Resin is a submission for substantial equivalence based on comparison to legally marketed predicate devices. The document does not describe a clinical study in the typical sense (e.g., a multi-reader, multi-case study with human-in-the-loop performance or standalone algorithm performance). Instead, it relies on bench testing and a comparison of material properties and indications for use to existing predicate devices.

Therefore, many of the requested details about acceptance criteria, study design, ground truth establishment, and expert involvement are not applicable in this context. The document focuses on demonstrating that the new device is as safe and effective as the predicate devices based on material characteristics and standard tests.

Here is an attempt to address the prompts based on the provided document, noting where information is not applicable (N/A) for this type of submission:

Acceptance Criteria and Device Performance for Nobilplast Denture Resin

The acceptance criteria for Nobilplast Denture Resin are implicitly based on demonstrating that its material properties and performance characteristics are substantially equivalent to its primary predicate device, FLEXSTAR V, and other reference devices (TCS Unbreakable, DENTSOLL Rezen NF, and Valplast). This is achieved through a series of bench tests and a comparison of intended use and material composition.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence submission based on direct comparison rather than a device with specific quantifiable "performance" in a diagnostic or assistive capacity, the acceptance criteria are framed as "similarity" or "comparability" to established predicate devices. The "reported device performance" is how Nobilplast Denture Resin's measured properties compare to those of the predicate.

Property	Acceptance Criteria (Implicit for Substantial Equivalence to Predicates)	Reported Nobilplast Denture Resin Performance
Intended Use	Must be substantially similar to predicate devices for fabrication of partial/full removable dentures, occlusal splints, and night guards.	Intended for the fabrication of partial or full removable dentures, as well as occlusal splints and night guards. (Minor differences from reference devices are explained as not practical for the material or application).
Type and Class	Must align with predicate devices (Type III, Class 1 denture material).	Type III, Class 1.
Chemical Family	Must be Polyamide, similar to predicate devices.	Polyamide.
CAS Number	Should be identical or closely related to the primary predicate (FLEXSTAR V: CAS# 25587-80-8).	CAS# 25587-80-8.
Material used to invest	Must be Dental Stone, similar to predicate devices.	Dental Stone.
Storage Temperature	Must be within a similar range to predicate devices (e.g., 60°F – 90°F).	60°F – 90°F.
Dosage	Must be consistent (1 cartridge).	1 cartridge.
Processing Time/Temperature	Must be comparable to predicate devices (e.g., primary predicate: 11 minutes @ 550°F (290°C)).	11 minutes @ 550°F (290°C) (furnace heats one cartridge at a time).
Injection Time	Must be comparable to predicate devices (e.g., primary predicate: 3 minutes).	3 minutes (using manual press).
Cool Time	Must be comparable to predicate devices (30 minutes).	30 minutes.
Physical Properties	Must demonstrate expected properties (semi-flexible, rigid thick sections, flexible thin sections for clasps) consistent with the material type and intended use, similar to predicate devices.	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. (Identical to description for FLEXSTAR V, DENTSOLL Rezen NF, and Valplast).
Bench Test Performance	Must meet standard industry specifications (ASTM, ISO) for material properties (Density, Melting Point, Hardness, Tensile, Flexural, Impact, Sorption & Solubility, DSC, TGA, Melt Flow Rate).	Subjected to various bench tests (Density per ASTM D792, Melting Point per ISO 11357, Hardness Shore per ISO 868, Tensile per ISO 527, Ultimate Flexural and 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). Specific numerical results are not provided in this summary but are implied to be within acceptable ranges to demonstrate equivalence.
Biocompatibility	Must demonstrate no biocompatibility issues.	Testing results indicate no biocompatibility issues exist for Nobilplast Denture Resin.
Shelf Life	Must demonstrate a reasonable shelf-life, comparable to predicate.	5-year shelf-life demonstrated by real-time packaging study on the nearly identical product: FlexStar V.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: The document does not specify a "sample size" in terms of cases or images for testing an AI device. Instead, it refers to the number of samples used for various bench tests of the material properties. These are standard material science tests, and the sample sizes would be defined by the specific ASTM/ISO standards referenced (e.g., a certain number of specimens for tensile strength, impact, etc.). The document does not provide these detailed sample counts.
Data Provenance: The data provenance is from laboratory bench testing of the Nobilplast Denture Resin material, as well as biological testing. This is not clinical data derived from patients or images. It is prospective testing performed on the manufactured material. The country of origin for the data is not explicitly stated, but the company is based in the USA.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

N/A. This is a material testing submission, not an AI or diagnostic device submission requiring expert human interpretation of data for ground truth. The "ground truth" here is the measured physical and chemical properties of the material, verified through standardized testing protocols (ASTM, ISO).

4. Adjudication Method for the Test Set

N/A. No human adjudication is involved for material properties testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

N/A. This type of study is for diagnostic or assistive devices involving human readers interpreting cases. Nobilplast Denture Resin is a material for fabricating dentures.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

N/A. This is not an algorithm or software device.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established through:

Standardized Bench Testing: Direct measurement of material properties (e.g., density, melting point, hardness, tensile strength, flexural properties, impact strength, sorption & solubility) according to internationally recognized ASTM and ISO standards.
Biocompatibility Testing: Evaluation of biological response as suggested by FDA Guidance (Cytotoxicity, Irritation, Sensitization tests).
Comparison to Predicate Devices: The established and legally marketed performance and safety profiles of the predicate devices (FLEXSTAR V, TCS Unbreakable, DENTSOLL Rezen NF, Valplast) serve as a de facto "ground truth" for substantial equivalence.

8. The Sample Size for the Training Set

N/A. There is no training set as this is not a machine learning or AI device.

9. How the Ground Truth for the Training Set Was Established

N/A. Not applicable.

Summary

{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). 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 (800) 638-2041 or (301) 796-7100 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

{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)
Prescription Use (Rx = 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. 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(K072402)	TCS Unbreakable(K053060)	DENTSOLL Rezen NF(K130680)	VALPLAST (9008371)Pre-amendment
IntendedUse	Nobilplast Denture Resinis used for the fabricationof partial or full removabledentures, as well asocclusal splints and nightguards.Note: The likelihood thatanyone would useNobilplast Denture Resinfor relining , repairing , andrebasing dentures isextremely low, which iswhy it was omitted fromthe indication for use.There are many otherways to perform theseprocedures which arefaster, easier, cheaperand more effective.Note: Occlusal splint isthe same as a "bite plate"as shown in DENTSOLL.Note: "personal trays" isthe same as animpression tray. No onewill use this type ofmaterial for thisapplication, which why itwas omitted fromNobilplast Denture Resin.	FLEXSTAR V isused for thefabrication of partialor full removabledentures, as well asocclusal splints andnight guards.	TCS® Unbreakable is abreak resistant materialused in the fabricationand repair of baseplates for removeabledental prostheticappliances wheresuperior flexibility andpatient comfort for thelifetime of the prostheticare significant concerns.This includes, but not tobe limited to, full andpartial dentures,orthodontic devices,occlusal splints,and night guards.	Intended formanufacturing, relining ,repairing , and rebasing ofpartial or fullremovable dentures,dental plates, bite plates ,personal trays , appliances,occlusal splints and nightguards.	Valplast is used for thefabrication of partial orfull removable dentures,Cosmetic Gum Veneers,Nightguards andOcclusal Splints, Onlays.Valplast applications canbe found here:https://www.valplast.com/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.

Regulation Number and Section

§ 872.3760 Denture relining, repairing, or rebasing resin.

(a)
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.(b)
Classification. Class II.