PINK CAD/CAM disc are blanks used in different milling machines (dental CAD-CAM systems) by professional dental technicians. They are composed of hot cured polymethyl methacrylate (PMMA) and pigments. Device is available in different pink shades. Discs of all shades are available in different dimensions (diameter, thickness and profile margin).

AI/ML Overview

The provided document describes the 510(k) premarket notification for the "PINK CAD/CAM Disc" for fabrication of dentures and compares it to a predicate device ("M-PM-Disc (Pink)") and a reference device ("PMMA CAD/CAM disc").

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Standard Requirement)	Reported PINK CAD/CAM Disc Performance	Predicate Device (M-PM-Disc Pink) Performance	Reference Device (PMMA CAD/CAM disc) Performance
E-modulus (MPa) (Minimum 2000 MPa per EN ISO 20795-1)	3040 MPa	2678 MPa	2771 MPa
Flexural Strength (MPa) (Minimum 65 MPa per EN ISO 20795-1)	115.8 MPa	90 MPa	114 MPa
Residual Methyl Methacrylate (%) (Maximum 2.2 wt-% per EN ISO 20795-1)	1.02 wt-%	1.14 wt-% (from literature)	1.02 wt-%
Biocompatibility: Cytotoxicity (EN ISO 10993-5)	Met requirements	Met requirements	Met requirements
Biocompatibility: Irritation (EN ISO 10993-10)	Met requirements	Test not performed	Met requirements
Biocompatibility: Sensitization (EN ISO 10993-10)	Met requirements	Met requirements	Met requirements

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

Sample Size: The document does not explicitly state the sample size for each test. For the E-modulus, flexural strength, and residual methyl methacrylate, it refers to "The test results... have been obtained with PINK CAD/CAM disc" and "The performance characteristics have been determinat_ed_ with PINK CAD/CAM disc," implying a test set was used, but the number of samples is not specified. For biocompatibility tests, it mentions that "testing was conducted on reference device PMMA CAD/CAM disc composed of Polident PMMA CAD/CAM disc material," again without specifying the sample size.
Data Provenance: The data appears to be prospective as the tests were "conducted" for the purpose of this 510(k) submission. The country of origin for the data generation is not explicitly stated, but the manufacturer (Polident d.o.o.) is based in Slovenia, suggesting the studies were conducted or commissioned there.

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

This information is not applicable to this type of device submission. The "ground truth" for the performance characteristics of dental materials like E-modulus, flexural strength, and residual monomer content is established by standardized laboratory testing methods (e.g., EN ISO 20795-1) and objective measurements, not by expert consensus or interpretation of subjective data. Similarly, biocompatibility studies (EN ISO 10993 series) involve standardized biological assays and observation, not expert ground-truthing in the sense of clinical image analysis.

4. Adjudication Method for the Test Set:

This information is not applicable for the reasons stated above. Adjudication methods like "2+1" or "3+1" are typically used in clinical or diagnostic studies where subjective interpretation is involved and consensus among experts is required to establish a ground truth. The tests performed for this device are quantitative and objective.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This is not applicable. The device "PINK CAD/CAM disc" is a material for fabricating dentures, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance is irrelevant to this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

This is not applicable. The device is a physical material, not an algorithm.

7. The Type of Ground Truth Used:

The "ground truth" for the device's performance is established through standardized laboratory testing using recognized international standards (EN ISO 20795-1 for mechanical and chemical properties, EN ISO 10993 series for biocompatibility). These standards define the test methodologies and acceptable limits, providing an objective "ground truth" for material properties and biological safety.

8. The Sample Size for the Training Set:

This is not applicable. The device is a physical material, not a machine learning model or algorithm, so there is no concept of a "training set" for its development or evaluation in this context. The manufacturing process is controlled, and the performance is verified through testing of representative samples.

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

This is not applicable as there is no training set.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 28, 2016

Polident D.O.O., Dental Products Industry Janja Lipuscek Head of Organic Programme Volcja Draga 42 Volcja Draga, 5293 SI

Re: K153546

Trade/Device Name: Pink Cad/cam Disc Regulation Number: 21 CFR 872.3760 Regulation Name: Denture Relining, Repairing, Or Rebasing Resin Regulatory Class: Class II Product Code: EBI, Dated: June 24, 2016 Received: July 7, 2016

Dear Janja Lipuscek:

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 (reporting of medical devicerelated 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 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 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. 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 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 yours,

Susan Runno DDS, MA

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) K153546

Device Name PINK CAD/CAM disc

Indications for Use (Describe)

Fabrication of dentures.

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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PoliDent

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Polident d.o.o. Dental Products Industry Volčja Draga 42 5293 Volčja Draga Telephone: 00386 5 3304840, Fax: 00386 5 3304870 SLOVENIJA

Title 5: 510(k) Summary

510(k) owner`s name:	Polident d.o.o. Dental Products Industry Volčja Draga 42 5293 Volčja Draga Slovenija Phone: 00386-53304840 Fax: 00386-53304870
Contact person:	mag. Janja Lipušček Phone: 00386-53304859 e-mail: janja.lipuscek@polident.si
Date of summary:	21st September, 2016
Trade name:	PINK CAD/CAM DISC
Classification name:	Denture relining, repairing, or rebasing resin
Product codes:	EBI
Regulation number:	21 CFR 872.3760
Device class:	II
Predicate device:	M-PM-Disc (Pink) Producer: Merz Dental GmbH 510 (k) Number: K140758
Reference device:	PMMA CAD/CAM disc Producer: Polident d.o.o. 510 (k) Number: K112967

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Device description:

PINK CAD/CAM disc are blanks used in different milling machines (dental CAD-CAM systems) by professional dental technicians.

They are composed of hot cured polymethyl methacrylate (PMMA) and pigments. Device is available in different pink shades. Discs of all shades are available in different dimensions (diameter, thickness and profile margin).

Indications for use:

Fabrication of dentures -

Summary of the technological characteristics compared to the predicate devices:

	Device:PINK CAD/CAM disc	Predicate device:M-PM-Disc (Pink)	Reference device:PMMA CAD/CAM disc
Form	Solid disc	Solid disc(the same)	Solid disc(the same)
Shades	Denture base colouredshade	Denture base colouredshade(the same)	Tooth coloured shade
Composition	Hot cured cross-linkedpolymethylmethacrylate	Hot cured cross-linkedpolymethylmethacrylate(the same)	Hot cured cross-linkedpolymethylmethacrylate(the same)
Material used	Polident PMMACAD/CAM discmaterial	OMP-N PMMAmaterial	Polident PMMACAD/CAM discmaterial(the same)
Manufacturer'stechnological processused	Polident PMMACAD/CAM discprocess	Merz Dental process	Polident PMMACAD/CAM discprocess(the same)
Fabrication	CAD/CAM technique	CAD/CAM technique(the same)	CAD/CAM technique(the same)
Indications for use	Fabrication of dentures	Fabrication of dentures(the same)	Fabrication oftemporary crowns andbridges
E-modulus (MPa)/EN ISO 20795-1/	3040	2678(the same)	2771(the same)
Fluxural strenght(MPa)/EN ISO 20795-1/	115,8	90(the same)	114(the same)
Residual methylmethacrylate (%)/EN ISO 20795-1/	1,02	1,14(the same)	1,02(the same)
Biocompatibility:cytotoxicity test/EN ISO 10993-5/	Met the requirementsof EN ISO 10993-5	Met the requirementsof EN ISO 10993-5(the same)	Met the requirementsof EN ISO 10993-5(the same)
Biocompatibility:irritation test/EN ISO 10993-10/	Met the requirementsof EN ISO 10993-10	Test has not beenperformed	Met the requirementsof EN ISO 10993-10(the same)
Biocompatibility:sensitization test/EN ISO 10993-10/	Met the requirementsof EN ISO 10993-10	Met the requirementsof EN ISO 10993-10(the same)	Met the requirementsof EN ISO 10993-10(the same)

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Substantial equivalence:

The proposed device PINK CAD/CAM disc, predicate device M-PM-Disc (Pink) and reference device PMMA CAD/CAM disc are composed of polymethyl methacrylate hot cured polymer. All three devices have the same aesthetic function and are intended to fabricate the final products by CAD/CAM technique and have similar physical and chemical properties. The polymerization grade of all devices is high.

The proposed device and predicate device M-PM-Disc (Pink) have the same indication for use and are available in pink shades.

The proposed device and reference device PMMA CAD/CAM disc are composed of the same material type and are manufactured under the same technological process with the same raw material used. The material is called Polident PMMA CAD/CAM disc material. As is evident from the table, some tests have been performed with Polident PMMA CAD/CAM disc material used for fabrication of proposed device PINK CAD/CAM disc and reference device PMMA CAD/CAM disc. The performance characteristics have been determinated with PINK CAD/CAM disc. The same tests have been performed also with OMP-N PMMA material used for predicate device M-PM-Disc (Pink).

The test results of E-modulus and flexural strength have been obtained with PINK CAD/CAM disc. The requirements of standard EN ISO 20795-1:2008: Dentistry-Base polymers –Part 1: Denture base polymers are that the required E-modulus of Type 1 material must be minimum 2000 MPa and required fluxural strength minimum 65 MPa. Both devices- PINK CAD/CAM disc and M-PM-Disc (Pink) comply with the requirements of standard EN ISO 20795-1 regarding the required flexural properties. The residual methyl methacrylate content of disc polymerised by Polident PMMA CAD/CAM disc material has been determined with regard to standard EN ISO 20795-1:2008: Dentistry- Base polymers -Part 1: Denture base polymers. The measured value is 1,02 wt-%. The requirement of residual monomer content with regard to EN ISO 20795-1 for Type 1 material is 2,2 wt-%. So PINK CAD/CAM disc complies the requirement of residual menthyl methacrylate content. In the literature company Merz Dental, the producer of predicate device M-PM-Disc (Pink), published that the amount of residual monomer in M-PM-Disc is 1,14 wt-%.

Therefore also cytotoxicity, sensitization and irritation testing was conducted on reference device PMMA CAD/CAM disc composed of Polident PMMA CAD/CAM disc material. The test results are that PMMA CAD/CAM disc material used for fabrication of reference device PMMA CAD/CAM disc and proposed device PINK CAD/CAM disc complies with the requirements of standard EN ISO 10993 regarding cytoxicity, irritation and sensitization properties. The Certificate of Compliance with ISO 10993: Biological Evaluation of Medical Devices for PMMA CAD/CAM disc has been issued.

We can conclude that the proposed device PINK CAD/CAM DISC has comparible technological characteristics to the predicate device. The device beeing considered to be substantially equivalent in safety and effectiveness to the predicate device.

Conclusion:

We are claimed substantial equivalence of PINK CAD/CAM DISC to the predicate device.

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.