PMMA CAD/CAM discs 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 A1, A2, A3, B1, B2, B3, BL3 and clear shades. Discs of all shades are available in different dimensions (diameter, thickness and profile margin).

AI/ML Overview

Here's an analysis of the provided text regarding the PMMA CAD/CAM disc, focusing on acceptance criteria and study details.

Important Note: The provided document is a 510(k) premarket notification summary. This type of submission generally aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific performance acceptance criteria through clinical trials. Therefore, the "acceptance criteria" discussed here are primarily related to material properties and safety tests, demonstrating equivalence to the predicate, rather than clinical performance metrics typically found in efficacy studies.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Property/Test)	Reported Device Performance (PMMA CAD/CAM disc)	Comparison to Predicate (ZENO PMMA disc)
Composition	Hot cured polymethyl methacrylate (PMMA) and pigments	Both composed of polymethyl methacrylate hot cured polymer
Indications for Use	Fabrication of temporary crowns and bridges	Similar indications for use
Physical Properties	Similar	Similar
Chemical Properties	Similar	Similar
E-modulus	Comparable	Comparable
Flexural Strength	Comparable	Comparable
Deflection	Comparable	Comparable
Polymerization Grade	High	High
Aesthetic Function	Same aesthetic function	Same aesthetic function
Biocompatibility:
- Cytotoxicity	Testing conducted	Not explicitly stated for predicate in this summary, but a demonstration of safety is implied for equivalence.
- Sensitization	Testing conducted	Not explicitly stated for predicate in this summary, but a demonstration of safety is implied for equivalence.
- Irritation	Testing conducted	Not explicitly stated for predicate in this summary, but a demonstration of safety is implied for equivalence.

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

The document does not describe a specific "test set" in the context of a clinical performance study. The equivalence is primarily based on material characterization and bench testing.

Sample Size: Not applicable in the context of a clinical test set. The material testing would have involved specific sample sizes for each physical/chemical property test, but these details are not provided in this summary.
Data Provenance: Not applicable for a clinical test set. The data would be derived from laboratory tests conducted on the PMMA CAD/CAM disc itself. No country of origin for clinical or retrospective/prospective data is mentioned as such studies were not performed for this submission.

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

This information is not applicable as the submission is for substantial equivalence based on material properties and bench testing, not on clinical performance requiring expert ground truth for a test set.

4. Adjudication Method for the Test Set

This information is not applicable as there was no clinical test set requiring expert adjudication.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. This device is a dental material (PMMA disc), not an AI-assisted diagnostic or therapeutic device. Therefore, no "human readers" or "AI assistance" are involved in its primary function for evaluating its effectiveness in the context of this 510(k) submission.

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

No, a standalone algorithm performance study was not done. This is a physical dental material, not an algorithm or AI system.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for demonstrating substantial equivalence relied on:

Material Science Benchmarks: Comparing the physical and chemical properties of the PMMA CAD/CAM disc to those of the predicate device.
Biocompatibility Standards: Results from cytotoxicity, sensitization, and irritation testing, presumably against recognized standards or established safety profiles.
Predicate Device Characteristics: The established and legally marketed characteristics of the ZENO PMMA disc served as the primary "ground truth" for comparison.

8. The Sample Size for the Training Set

This information is not applicable. This submission is for a physical medical device (dental material), not a machine learning model, so there is no "training set."

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

This information is not applicable as there is no training set for this device type.

Summary

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KII2967

PoliDent ഇ

AUG 28 8 2012

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:

Trade name:

Classification name: Product code: Regulation number: Device class:

Temporary crown and bridge resin EBG 872.3770 ll

Legally marked equivalent device: 510(k) number:

ZENO PMMA disc K080182

27th August, 2012

PMMA CAD/CAM DISC

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Device description:

PMMA CAD/CAM discs 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 A1, A2, A3, B1, B2, B3, BL3 and clear shades. Discs of all shades are available in different dimensions (diameter, thickness and profile margin).

Indications for Use:

fabrication of temporary crowns and bridges. -

Summary of the technological characteristics compared to the predicate device:

Polident PMMA CAD/CAM discs are substantially equivalent to the dental device ZENO PMMA disc.

The proposed and predicate devices are both composed of polymethyl metacrylate hot cured polymer and have similar indications for use. The proposed and predicate devices have similar physical and chemical properties. The polymerization grade of both devices is high. They have the same aesthetic function.

We can conclude that Polident PMMA CAD/CAM disc has comparible technological characteristics to the predicate device.

Substantial equivalence:

The proposed and predicate devices are both composed of polymethyl metacrylate hot cured polymer. Both devices have similar indications for use. The proposed and predicate devices have similar physical and chemical properties. Both devices have comparable e-modulus, flexural strength and deflection. The polymerization grade of both devices is high. They have the same aesthetic function.

Cytotoxicity, sensitization and irritaton testing was conducted on PMMA CAD/CAM discs.

Conclusion:

We are claiming substantial equivalence of PMMA CAD/CAM disc to the predicate device ZENO PMMA disc.

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Image /page/2/Picture/1 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's name in a circular arrangement around the edge. In the center of the seal is the department's logo, which is a stylized image of a person embracing another person.

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

Ms. Janja Lipušček Polident d.o.o., Dental Products Industry Volčja Draga 42 Volčja Draga Slovenia 5293

AUG 28 2012

Re: K112967 Trade/Device Name: PMMA CAD/CAM disc Regulation Number: 21 CFR 872.3770 Regulation Name: Temporary Crown and Bridge Resin Regulatory Class: II Product Code: EBG Dated: August 20, 2012 Received: August 23, 2012

Dear Ms. 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.

Page 2- Ms. Lipuscek

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Page 2- Ms. Lipuscek

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 115809.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,

Nh for

Anthony B. Watson, BS, MS, MBA Director Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K112967

PoliDent

ഇ

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

Title 4: Indications for Use Statement

510(k) Number (if known): K112967

Device Name: PMMA CAD/CAM disc

Indications For Use:

fabrication of temporary crowns and bridges -

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

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runner

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

510(k) Number:

Page 1 of 1

Regulation Number and Section

§ 872.3770 Temporary crown and bridge resin.

(a)
Identification. A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.(b)
Classification. Class II.