The PMMA is a highly cross-linked material manufactured by Merz Dental GmbH under a proprietary process and branded as OMP-N. MP-M-Disc (Pink) is composed of > 95 % PMMA with less than 2% MMA residual. Additional components are coloring agents that include: titanium dioxide, iron oxide yellow, iron oxide black, iron oxide red, azocondensation pigment red, and rayon fibers for veined shades.

AI/ML Overview

This document describes the M-PM-Disc (Pink), a dental device used for the fabrication of dental bases for removable dentures. The submission is a 510(k) premarket notification to the FDA. The following information addresses the requested points based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the M-PM-Disc (Pink) are based on international standards for dentistry (ISO 10477 and ISO 20795-1). The device's performance is reported directly against these standards.

Physical Parameter	Standard (ISO)	Acceptance Criteria (Implicit: Meet Standard)	Reported Device Performance (OMP-N)
Flexural strength (MPa)	10477	Meets ISO 10477 requirements	93.4
Water sorption (ug/mm³)	10477	Meets ISO 10477 requirements	26.5
Water solubility (ug/mm³)	10477	Meets ISO 10477 requirements	0.2
Flexural modulus (MPa)	20795-1	Meets ISO 20795-1 requirements	2678 ± 74
Flexural strength (MPa)	20795-1	Meets ISO 20795-1 requirements	90 ± 1.5
Residual methyl methacrylate (Mass % Fraction)	20795-1	Meets ISO 20795-1 requirements	1.14
Fracture Toughness (Kmax) (MPa m^1/2)	20795-1	Meets ISO 20795-1 requirements	1.41 ± 0.04
Fracture work (Wf) (J/m2)	20795-1	Meets ISO 20795-1 requirements	202 ± 13

The device also underwent biocompatibility testing according to ISO 10993-5 (in vitro cytotoxicity) and ISO 10993-10.2 (guinea pig sensitization model), and "met the applicable standards", showing it was nontoxic and non-sensitizing.

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

The document does not explicitly state the sample sizes for the test sets used for each specific physical parameter measurement. However, typical laboratory testing for material properties involves multiple samples to ensure statistical significance. The data provenance is implied to be from Merz Dental GmbH's internal testing, as they "tested OMP-N for physical/chemical properties and biocompatibility." The country of origin of the data would be Germany, given Merz Dental GmbH's address. The data is prospective, generated specifically for this regulatory submission.

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

This document does not involve a test set requiring expert ground truth in the way a medical imaging AI would. The "ground truth" for the material properties is established by the standardized testing methodologies of ISO 10477 and ISO 20795-1. The experts involved would be the laboratory technicians and scientists performing the tests and interpreting the results according to these international standards. Their qualifications would involve expertise in materials science, mechanical testing, and adherence to ISO guidelines.

4. Adjudication Method for the Test Set

Not applicable. The evaluation of material properties by objective, standardized laboratory tests does not typically involve human adjudication in the same way clinical diagnostic assessments do. Results are typically measured directly and compared against pre-defined thresholds within the ISO standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This device is a material for dental fabrication, not a diagnostic AI tool that would involve human readers interpreting cases.

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

Yes, in a sense, a "standalone" evaluation of the material properties was performed. The OMP-N PMMA material was tested in isolation, and its physical and biocompatibility characteristics were measured and compared directly against performance standards. There is no "human-in-the-loop" performance associated with the material's inherent properties.

7. The Type of Ground Truth Used

The ground truth used for evaluating the M-PM-Disc (Pink) is based on established international standards for dentistry (ISO 10477, ISO 20795-1, ISO 10993-5, ISO 10993-10.2). These standards define the acceptable range or minimum/maximum values for various physical, chemical, and biological properties of dental polymer materials.

8. The Sample Size for the Training Set

Not applicable. This submission is for a material (M-PM-Disc), not an AI algorithm. Therefore, there is no concept of a "training set" in the context of machine learning. The robust properties of the PMMA material are inherent to its composition and manufacturing process.

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

Not applicable, as there is no training set for an AI algorithm. The material's properties (strength, water sorption, etc.) are intrinsic and established through standardized scientific testing processes.

Summary

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

September 15, 2014

Merz Dental GmbH c/o Richard G. Hunter, MS Regulatory Affairs Consultant Washington Regulatory Consultants 5616 Mariola PL NE Albuquerque, NM 87111

Re: K140758

Trade/Device Name: M-PM-Disc (Pink) Regulation Number: 21 CFR 872.3760 Regulation Name: Denture relining, repairing, or rebasing resin Regulatory Class: II Product Codes: EBI, EBG Dated: August 5, 2014 Received: August 12, 2014

Dear Mr. Hunter:

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.

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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 (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.

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" (21CFR 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,

Mary S. Runner -S

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known):

Device Name: M-PM-Disc (Pink)

Indications for Use:

Device for fabrication of dental bases for removable dentures.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use

(21 CFR Part 801 Subpart D)

(21 CFR Part 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

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510(k) Summary

Merz Dental GmbH M-PM-Disc (Pink)

Submitter

Company Name:	Merz Dental GmbH
Address:	Eetzweg 20Lutjenburg, Germany D-24321
Contact Name:	Dr. Med. Claudia Bobrowski
Telephone No.	(011) 43 81/4 03-4 11
Fax No.	(011) 43 81/4 09-1 07
e-mail:	Claudia.bobrowski@merz-dental.de
Date of Summary:	August 5, 2014
Device Name
Proprietary name:	M-PM-Disc (Pink)
Common name:	Denture Base
Classification name:	Resin, Denture, Relining, Repairing, Rebasing
Predicate Devices:	Denture Resins ((e.g. Promolux)For Casting of Denture BasesK130076Merz Dental GmbHM-PM-Disc (Tooth Colored)For Fabrication of Crowns and BridgesK071548Merz Dental GmbH

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Intended Use

Merz Dental GmbH M-PM-Disc (Pink) is a device for fabrication of dental bases for removable dentures.

Device Description

The Merz Dental GmbH M-PM-Disc (Pink) is a disc composed of solid polymethylmethacrylate (PMMA) in sizes ranging from 90 x15 mm to 114.8 x 25 mm.

Technological Characteristics

The Merz Dental GmbH OMP-N PMMA has been tested according to the following standards. The results are presented in the table below.

Physical Parameter*	Standard (ISO)	OMP-N
Flexural strength(MPa)	10477	93.4
Water sorption(ug/mm³)	10477	26.5
Water solubility(ug/mm³)	10477	0.2
Flexural modulus(MPa)	20795-1	2678±74
Flexural strength(MPa)	20795-1	90 ± 1.5
Residual methyl methacrylate(Mass % Fraction)	20795-1	1.14
Fracture Toughness (Kmax)(MPa m^1/2)	20795-1	1.41 +- 0.04
Fracture work (Wf)(J/m2)	20795-1	202 +- 13

Substantial Equivalence

M-PM-Disc (Pink) is substantially equivalent to predicate denture base resin systems, such as the Merz Dental GmbH Denture Base Resins one of which is the hot-curing Promolux and

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Merz Dental GmbH M-PM Disc (Tooth Colored) for fabrication of crowns and bridges. The three devices are compared in the table below.

Device	M-PM-Disc (Pink)	Promolux (Pink)	M-PM-Disc(Tooth Colored)
Indications	Device for fabricationof denture bases	Resin system forfabrication of denturebases	Device for fabrication ofcrowns and bridges
MaterialComposition	OMP-N PMMA	PMMA	OMP-N PMMA
Material Form	Solid Disc	Powder and Liquid	Solid Disc
Fabrication	Milling	Casting	Milling
Clearance	Subject ofApplication	K130076	K071548
Manufacturer	Merz Dental, GmbH	Merz Dental, GmbH	Merz Dental, GmbH

As shown in the table, both the M-PM-Disc (Pink) and Promolux are composed of polymethylmethacrylate (PMMA) with pink colorants, and are indicated for the fabrication of dental bases. In addition the M-PM-Disc (Pink) has the identical material composition, method of manufacture, and final fabrication method as the Merz Dental GmbH M-PM-Disc (Tooth Colored), a device for fabrication of crowns and bridges. Both M-PM-Disc (Pink) and M-PM-Disc (Tooth Colored) are solid PMMA discs composed of highly cross-linked PMMA (OMP-N), and milled at the dental lab into the final shape of the prosthesis.

Merz Dental has tested OMP-N for physical/chemical properties and biocompatibility. The PMMA material met the applicable standards for physical/chemical properties (ISO 10477 and 20795-1), and was nontoxic and non-sensitizing in the in vitro cytotoxicity test system (ISO 10993-5) and the guinea pig sensitization model (ISO 10993-10.2).

Summary

Merz Dental GmbH M-PM-Disc (Pink) has similar indications, composition, manufacturing methods and biocompatibility as the predicate devices. Therefore Merz Dental considers the M-PM-Disc (Pink) to substantially equivalent to the predicate devices.

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.