artegral HD are preformed posterior plastic teeth made from an Interpenetrated Network (IPN) of polymethylmethacrylate (PMMA) with two finer Networks. The tooth neck is made from Organic Modified Polymer Network (OMP-N) and the incisal and dentine portions of the tooth are made from Highly Modified Polymer-Network (HMP-N). OMP-N has added insoluble PMMA spheres, and HMP-N has added amorphous silicon dioxide nanoparticles and fluorapatite. The artegral HD teeth comply with all the requirement of ISO 22112:2005 Dentistry - Artificial teeth for dental prostheses. The additives in artegral HD teeth are known biocompatible materials.

AI/ML Overview

The provided document, K120404, pertains to the 510(k) premarket notification for the Merz Dental GmbH artegral HD preformed plastic denture teeth. This submission focuses on chemical and physical characteristic comparisons to a predicate device, rather than a diagnostic AI device requiring performance metrics like sensitivity or specificity. Therefore, many of the requested categories related to AI device performance evaluation are not applicable.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (from ISO 22112:2005 and ISO/CD 20795-1)	Reported Device Performance (artegral HD)
ISO 22112:2005 Dentistry - Artificial teeth for dental prostheses requirements:	The artegral HD teeth complied with all the requirements of this standard. (Specific requirements like hardness, fracture resistance, color stability are implied to be met as per the standard but not detailed in the summary).
ISO/CD 20795-1 "Dentistry - Base polymers - Part 1: Denture base polymers" (Type 1:Class 1) - Residual Methyl Methacrylate Monomer (MMA) Limit:	The average concentration of residual MMA was well below the limit given in the standard.
Biocompatibility requirements (USP 29, ISO 10993 Part 5, EC method B.6., OECD guideline 406, EN/ISO/DIN 10993-10.2):	Cytotoxic Properties (HMP-N): Acceptable results in a cell culture test. Eye Irritancy Potential (HMP-N): Acceptable results in the Chorioallantoic Membrane Assay. Skin Sensitization (HMP-N): Acceptable results in the Maximization Test in Guinea Pigs.

2. Sample size used for the test set and the data provenance:

The document does not specify a "test set" in the context of diagnostic data. The testing involved samples of the artegral HD teeth and their material components.
Data Provenance: The tests were conducted internally by Merz Dental GmbH (Germany). The specific labs or testing facilities are not detailed, but the document refers to compliance with international standards (ISO, USP, EC, OECD, EN/DIN), implying standard testing methodologies. All testing was prospective, as it was performed on the device components for the purpose of this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This device is not a diagnostic tool requiring expert interpretation of images or clinical data to establish ground truth. The "ground truth" here is compliance with established physical, chemical, and biological standards.

4. Adjudication method for the test set:

Not applicable. See point 3.

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:

Not applicable. This device is not an AI-assisted diagnostic tool.

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

Not applicable. This device is not an algorithm. Performance testing was done on the physical product and its constituent materials.

7. The type of ground truth used:

Standard-based compliance: The ground truth for this device is based on the requirements and limits defined in established international and national standards for artificial denture teeth and biocompatibility, such as:
- ISO 22112:2005 Dentistry - Artificial teeth for dental prostheses
- ISO/CD 20795-1 "Dentistry - Base polymers - Part 1: Denture base polymers"
- USP 29 (United States Pharmacopeia)
- ISO 10993 Part 5 (Biological evaluation of medical devices - Tests for in vitro cytotoxicity)
- EC method B.6. (European Commission method)
- OECD guideline 406 (OECD Guidelines for the Testing of Chemicals - Skin Sensitisation)
- EN/ISO/DIN 10993-10.2 (Biological evaluation of medical devices - Tests for irritation and skin sensitization)

8. The sample size for the training set:

Not applicable. This device does not use machine learning, so there is no training set.

9. How the ground truth for the training set was established:

Not applicable. See point 8.

In summary: The K120404 submission for Merz Dental GmbH artegral HD preformed plastic denture teeth is primarily a substantial equivalence claim based on demonstrating that the device meets the physical, chemical, and biological safety requirements of relevant international standards. It does not involve AI or diagnostic performance studies that would utilize concepts like ground truth established by experts, test sets, or training sets. The "proof" that the device meets acceptance criteria comes from the successful completion of the specified laboratory tests according to the cited standards.

Summary

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K120404

. MAY 2 1 2012

DENTAL

. . . . .

Merz Dental GmbH

Eetzweg 20 · D-24321 Lütjenburg Postlach: 12 80 · D-24319 Lütjenburg Telefon: +49 (0) 4381-403-0 Telefax: +49 (0) 4381-4 03-100 info@merz-dental.de E-mail: Internet: www.merz-dental.de

510(k) Summary

Merz Dental GmbH artegral HD preformed plastic denture teeth

Submitter

Address:

Merz Dental GmbH Company Name:

Eetzweg 20 Lutjenburg, Germany D-24321

Contact Name: Telephone No. Fax No. e-mail:

Dr. Med. Claudia Bobrowski (011) 43 81/4 03-4 11 (011) 43 81/4 09-1 07 Claudia.bobrowski@merz-dental.de

April 20, 2012 Date of Summary:

Device Name

Proprietary name: artegral HD

Denture teeth Common name:

Classification name: Denture, plastic, teeth (21CFR 872.3590 Product Code ELM)

Predicate Device

K030588, Merz Dental GmbH artegral and Polystar Selection Denture Plastic Teeth

Device Description

artegral HD are preformed posterior plastic teeth made from an Interpenetrated artegrair Network (IPN) of polymethymethylmethacrylate (PMMA) with two r orfiner Notwork (1) 100th neck is made from Organic Modified Polymer

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Network (OMP-N) and the incisal and dentine portions of the tooth are made from Highly Modified Polymer-Network (HMP-N). OMP-N has added insoluble PMMA spheres, and HMP-N has added amorphous silicon dioxide nanoparticles and fluorapatite. The artegral HD teeth comply with all the requirement of ISO 22112:2005 Dentistry - Artificial teeth for dental prostheses. The additives in artegral HD teeth are known biocompatible materials.

Intended Use

The artegral HD (high definition) teeth have the same intended use as artegral posterior preformed plastic denture teeth cleared in K030588. As described below, the intended use for artegral HD plastic teeth is described in more detail than the predicate artegral plastic teeth.

Artegral HD posterior preformed plastic denture teeth intended use:

. Supra construction for combined, fixed removable dental prostheses
Hybrid construction for . implant-supported dental prostheses
Cover denture .
. Total prostheses
Model cast prostheses ●
· · Partial dentures

Technological characteristics and substantial equivalence

The device is comparable in chemical composition to the predicate device.

The device is similar in size, shape, color and usage to the predicate device.

Both the device and the predicate device comply with the physical characteristic requirements of ISO 22112:2005 Dentistry - Artificial teeth for dental prostheses.

Performance Testing

The artegral HD teeth were tested according to ISO 22112:2005 Dentistry - Artificial teeth for dental prostheses and shown to comply with all the requirements of the standard.

teeth intended use:

Artegral posterior preformed plastic

Denture teeth .

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Test of the artegral HD teeth was performed according to ISO/CD 20795-1 "Dentistry - Base polymers - Part 1: Denture base polymers" (Type 1:Class 1) to judge if there will be a risk from residual methyl methacrylate monomer which can be eluted from the teeth in the oral cavity. The average concentration of residual MMA was well below the limit given in the standard.

Testing for biocompatibility was also performed as follows and all test results were acceptable:

Examination of an Eluate of HMP-N for Cytotoxic Properties in a Cell Culture Test, according to USP 29 and ISO 10993 part 5, Elution Test

Screening for Eye Irritancy Potential of HMP-N in the Chorioallantoic Membrane Assay

Examination of HMP-N in the Skin Sensitization Test in Guinea Pigs According to Magnusson and Kligman (Maximization Test), according to EC method B.6. (96/54/EC), OECD guideline 406 and EN/ISO/DIN 10993-10.2

Clinical Performance

The determination of substantial equivalence is not based on clinical performance data.

Other Information

No other information was deemed necessary by FDA.

Conclusions

artegral HD is substantially equivalent to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three overlapping wings, symbolizing health, services, and human. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Public Health Service

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

Merz Dental GmbH C/O Mr. Richard G. Hunter Principal Washington Regulatory Consultants 5616 Mariola Place, NE Albuquerque, New Mexico 87111

MAY 2 1 2012

Re: K120404

Trade/Device Name: Artegral HD Regulation Number: 21 CFR 872.3590 Regulation Name: Preformed Plastic Denture Tooth Regulatory Class: II Product Code: ELM Dated: May 10, 2012 Received: May 11, 2012

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm 1 1 5809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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,

ht for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, 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): K120404

Device Name: artegral HD

Indications for Use:

Artegral HD are posterior preformed plastic denture teeth for use in:

supra construction for combined, fixed removable dental prostheses .
hybrid construction for implant-supported dental prostheses .
cover denture .
total prostheses .
model cast prostheses ●
. partial dentures

Prescription Use × (21 CFR Part 801 Subpart D) AND/OR

Over-The-Counter Use (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)

Swart Roaser

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: __

Page 1 of

12 of 189 (amended)

Regulation Number and Section

§ 872.3590 Preformed plastic denture tooth.

(a)
Identification. A preformed plastic denture tooth is a prefabricated device, composed of materials such as methyl methacrylate, that is intended for use as a tooth in a denture.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.