Predicate Devices

Reference Devices

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

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the material properties and biocompatibility of a denture resin, with no mention of AI or ML.

Therapeutic

No.
The Nobilplast Denture Resin is intended for the fabrication of dental devices (dentures, splints, night guards), not for direct therapeutic use on a patient. It is a material used to create devices that might serve a therapeutic purpose, but the resin itself is a material, not a therapeutic device.

Diagnostic

No

Explanation: The device is a resin used for fabricating dentures, occlusal splints, and night guards, which are prosthetic or protective devices, not diagnostic ones. The provided information focuses on material properties and biocompatibility.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a polyamide (nylon) resin, which is a physical material used for fabrication, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, Nobilplast Denture Resin is not an In Vitro Diagnostic (IVD) device.

Here's why:

Intended Use: The intended use is for the fabrication of partial or full removable dentures, occlusal splints, and night guards. These are devices used in the mouth for structural and functional purposes, not for testing samples outside the body to diagnose or monitor a medical condition.
Device Description: The description details a material (polyamide resin) used to create physical dental prosthetics.
Performance Studies: The performance studies focus on the physical and mechanical properties of the material and its biocompatibility when used in the body, not on its ability to detect or measure substances in biological samples.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.

IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. Nobilplast Denture Resin is a material used to create a medical device that is placed in the body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

EBI

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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 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.

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K072402 FlexStar V Resin

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

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

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

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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 (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

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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)
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)

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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: 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

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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.

Page 2 of 5

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Property		Primary Predicate
Property	Nobilplast Denture Resin	FLEXSTAR V
(K072402)	TCS Unbreakable
(K053060)	DENTSOLL Rezen NF
(K130680)	VALPLAST (9008371)
Pre-amendment
Intended
Use	Nobilplast Denture Resin
is used for the fabrication
of partial or full removable
dentures, as well as
occlusal splints and night
guards.

Note: The likelihood that
anyone would use
Nobilplast Denture Resin
for relining , repairing , and
rebasing dentures is
extremely low, which is
why it was omitted from
the indication for use.
There are many other
ways to perform these
procedures which are
faster, easier, cheaper
and more effective.

Note: Occlusal splint is
the same as a "bite plate"
as shown in DENTSOLL.

Note: "personal trays" is
the same as an
impression tray. No one
will use this type of
material for this
application, which why it
was omitted from
Nobilplast Denture Resin. | FLEXSTAR V is
used for the
fabrication of partial
or full removable
dentures, as well as
occlusal splints and
night guards. | TCS® Unbreakable is a
break resistant material
used in the fabrication
and repair of base
plates for removeable
dental prosthetic
appliances where
superior flexibility and
patient comfort for the
lifetime of the prosthetic
are significant concerns.
This includes, but not to
be limited to, full and
partial dentures,
orthodontic devices,
occlusal splints,
and night guards. | Intended for
manufacturing, relining ,
repairing , and rebasing of
partial or full
removable dentures,
dental plates, bite plates ,
personal trays , appliances,
occlusal splints and night
guards. | Valplast is used for the
fabrication of partial or
full removable dentures,
Cosmetic Gum Veneers,
Nightguards and
Occlusal Splints, Onlays.

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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.