The Merz Dental MP-M-Disc (Clear) is a solid disc composed of a highly cross-linked homogenous combination of polymethylmethacrylate (PMMA) copolymers known as an Interpenetrated Polymer Network (IPN). This is the same material used in Merz Dental artegral Denture Teeth (K030588) and the Merz Dental M-PM-Disc (Tooth Colored) (K071548). The difference is that the MPM-Disc (Clear) PMMA does not have added pigments. The M-PM-Disc (Clear) PMMA contains polymethylmethacrylate cross-linked polymer based on methacrylic acid esters, residual peroxide and residual monomer up to a maximum of 1%. It is offered in sizes from 90 x15 mm to 114.8 x 25 mm. Bite splints are prepared from the disc using a milling technique.

AI/ML Overview

The provided document describes a 510(k) premarket notification for a dental device, the Merz Dental GmbH M-PM-Disc (Clear). This submission focuses on establishing substantial equivalence to previously marketed devices based on non-clinical testing and shared material properties, rather than an AI/ML-based device. Therefore, many of the requested categories related to AI/ML device studies (such as sample sizes for test sets, expert ground truth, MRMC studies, standalone performance, training sets, etc.) are not applicable in this context.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (ISO Standard)	Performance Standard	Reported Device Performance (M-PM-Disc (Clear))
Flexural Strength	>65 MPa	Meets applicable ISO Standard (>65 MPa)
Flexural Modulus	>2000 MPa	Meets applicable ISO Standard (>2000 MPa)
Water Absorption	< 40 g/mm^3	Meets applicable ISO Standard (< 40 g/mm^3)
Solubility	< 7.5 mcg/mm^3	Meets applicable ISO Standard (< 7.5 mcg/mm^3)
Biocompatibility	Compliance with ISO 10993-1	Compliance with ISO 10993-1 (non-cytotoxic, non-irritating, non-sensitizing)
Material Properties (PMMA)	Compliance with ISO 3336:1996	Meets requirements of ISO 3336:1996

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

Not applicable. This is not an AI/ML study. The "test set" here refers to physical and chemical tests on the material itself, not a dataset for an algorithm. The testing was performed on the PMMA material used in the device and a virtually identical PMMA from a previously approved device (Merz Dental artegral plastic teeth).

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

Not applicable. This is not an AI/ML study. Ground truth was established by adherence to recognized international standards (ISO 1567, ISO 10993-1, ISO 3336:1996) and laboratory testing. The qualifications of the testing personnel are not disclosed but would presumably be laboratory technicians and engineers experienced in material science testing.

4. Adjudication Method for the Test Set

Not applicable. This is not an AI/ML study. Compliance with ISO standards is determined by predefined testing protocols, not human adjudication in the typical sense of a clinical study.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This is not an AI/ML study, and therefore, an MRMC comparative effectiveness study was not conducted. The study focuses on material properties and biocompatibility.

6. Standalone (Algorithm Only) Performance Study

No. This is not an AI/ML device or algorithm. The performance being evaluated is the physical and biological characteristics of the dental material.

7. Type of Ground Truth Used

The ground truth used was international standards for material properties and biocompatibility. Specifically:

Physical Properties: ISO 1567 (Dentistry - Denture Base Polymers)
Biocompatibility: ISO 10993-1 (Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process)
Material Composition: ISO 3336:1996 (Dentistry - Synthetic Polymer Teeth)

8. Sample Size for the Training Set

Not applicable. This is not an AI/ML study and does not involve a training set. The "training" here would refer to the extensive research and development process that led to the formulation of the PMMA material, not a data training set for an algorithm.

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

Not applicable. There is no training set in the context of an AI/ML device. The "ground truth" for the material's development would be based on established principles of polymer chemistry and dental material science, aiming to meet the performance criteria outlined in the relevant ISO standards.

Summary of the Study and Device Justification:

The study aims to demonstrate that the Merz Dental GmbH M-PM-Disc (Clear) device is substantially equivalent to predicate devices. This is achieved through non-clinical testing, primarily focusing on:

Identical Intended Use: Fabrication of removable bite splints (mouthguards and nightguards).
Identical Composition: Acrylic Polymer (PMMA).
Identical Colorants: None (Clear).
Compliance with Relevant ISO Standards for Physical Properties: The device's PMMA material was tested according to ISO 1567 for Flexural Strength, Flexural Modulus, Water Absorption, and Solubility. The reported performance meets the limits specified by the standard.
Compliance with Relevant ISO Standards for Biocompatibility: The PMMA material was tested according to ISO 10993-1, demonstrating it was non-cytotoxic, non-irritating, and non-sensitizing. This testing was performed on a virtually identical PMMA (Merz Dental artegral plastic teeth) which confirmed the material's biocompatibility.
Compliance with Material Standard: The PMMA material (as represented by the artegral plastic teeth) also meets the requirements of ISO 3336:1996.

The key difference noted is the fabrication method (milling for the M-PM-Disc (Clear) vs. thermoforming for the predicate K062828). However, the material properties and biocompatibility, as confirmed by non-clinical testing against established ISO standards, justify its substantial equivalence. No clinical testing was deemed necessary.

Summary

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K134.015

APR 1 1 2014

510(k) Summary

Merz Dental GmbH M-PM-Disc (Clear)

Submitter:	Merz Dental GmbHEetzweg 20Lutjenburg, Germany D-24321
Contact:	Richard G. Hunter, MS, RAC505.400.4992; wrchunter@comcast.net
Date of Summary:	April 8, 2014
Trade Name:	M-PM-Disc (Clear)
Regulation Name:	Mouthguard
Regulation Class:	Not Classified
Product Code:	MQC
Predicate Devices:	K062828 -- Mouthguard and Aligner Materials, DENTSPLY Intl.K030588 -- artegral Denture Teeth, Merz Dental GmbHK071548 -- M-PM-Disc (Tooth Colored), Merz Dental, GmbH

Device Description:

Intended Use

The Mertz Dental GmbH M-PM-Disc (Clear) is indicated for the fabrication of removable bite splints such as mouthguards and nightguards.

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Technological characteristics and substantial equivalence

The MP-M-Disc (Clear ) has the same indications for use and configurations as the predicate devices. It also has the same composition (acrylic polymers) which meet the ISO requirements for physical properties and biocompatibility for these dental indications. The M-PM-Disc (Clear) and the predicate device differ in their method of fabrication. M-PM-Disc (Clear) is milled from solid PMMA whereas the predicate device (Mouthguard and Aligner Material, K062828) is thermoformed. Side-by-side comparisons of the properties of the M-PM-Disc (Clear) bite splint to the predicate is presented below in Table 1. Based on these comparisons, the MP-M-Disc (Clear) is not significantly different, and thus substantially equivalent, to the predicate devices.

	M-PM-Disc (Clear)	Mouthguard andAligner MaterialsK062828
Intended Use	Bite Splint/Mouthguard	Same
Composition	Acrylic Polymer (PMMA) Solid	Same
Colorants	None	Same
Fabrication Method	Milling	Thermoforming
Physical Properties	Meets applicable ISO StandardTested to ISO 1567:Flexural Strength Limit: >65 MPaFlexural Modulus: >2000 MPaWater Absorption: < 40 g/mm3Solubility: <7.5 mcg/mm3	Meets applicableISO Standard
Biocompatibility	Compliance with ISO 10993-1	Same

Table 1: Comparison of M-PM-Disc (Clear) Bite Splint to Predicate Device

Clinical and Non-Clinical Performance:

The M-PM-Disc (Clear) has not been tested clinically.

Both the M-PM-Disc (Clear) and the predicate devices are fabricated from PMMA. The PMMA used in M-PM-Disc (Clear) has been tested for biocompatibility and physical properties according ISO 10993-1 tissue contacting requirements. The testing was performed on a virtually identical PMMA--Merz Dental artegral plastic teeth, since the latter material is identical to that of M-PM-Disc (Clear) but has added tooth-color pigments. The material met the biocompatibility requirements of ISO 10993-1--in particular the material was non-cytotoxic, non-irritating and non-sensitizing. The M-PM-Disc (Clear) material, as represented by the PMMA (tooth colored) in Merz Dental artegral plastic teeth, also meets the requirements of ISO 3336:1996, Dentistry-Synthetic, Polymer Teeth).

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The tests discussed above and in the non-clinical testing section indicate that the subject device is safe and effective for its intended use and performs as well or better than predicate device(s).

Conclusion:

The non-clinical testing results indicate that the subject device is safe and effective for its intended use and performs as well or better than predicate device(s). Therefore, the M-PM-Disc (Clear) is substantially equivalent to the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of an eagle or bird-like figure with three curved lines representing its wings or body.

Public Health Service

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

April 11, 2014

Mertz Dental GmbH c/o Richard Hunter, MS, RAC Principal Washington Regulatory Consultants 5616 Mariola Place Albuquerque, NM 87111

Re: K134015

Trade/Device Name: M-PM-Disc (Clear) Regulation Number: None Regulation Name: Mouthguard Regulatory Class: Unclassified Product Code: MQC Dated: January 21, 2014 Received: January 23, 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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Page 2 - Mr. Hunter

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 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

MarySRunner -S

Erin I. Keith, M.S. Acting Division 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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K134015/S2 Response to Deficiencies Merz Dental GmbH

Indications for Use

K134015 510(k) Number (if known):

Device Name: M-PM-Disc (Clear)

Indications for Use:

The Merz Dental GmbH M-PM-Disc (Clear) is indicated for the fabrication of removable bite splints such as mouthguard and nightguards.

Prescription Use X

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)

Michael E. Adjodha -S 2014.04.10 14:12:13 -04'00'

Regulation Number and Section

N/A