Acrylic polymer blank particularly suitable for making removable or temporary dental structures such as crowns and bridges using milling technology using CAD/CAM. Indications:

Temporary anterior and posterior crowns
Temporary anterior and posterior bridges with up to two adjacent pontics
Implant supported temporary restorations

Maximum recommended usage period: 12 months

Removable structures for dentures (dental bases)
Removable structures for therapeutic restorations (bite splints or occlusal splints)

Device Description

Dental polymer blank is a circular solid (disc) or rectangular solid (block) of PMMA with or without post attachment for use in a Cad-controlled milling machine for production of provisional restorative prostheses such as dental crowns and bridges and removable dental structures. These blanks are available in a variety of shapes for different milling systems and are also available in variety of dental shades.

Dental polymer blanks are made with the same material (Hot cured PMMA) that is used for the manufacture of the Union Dental artificial teeth brands ODILUX and ODIPAL (K070591). These polymer discs or blocks are especially suited for creating dental structures by means of milling CAD/CAM techniques commonly used in the dental laboratories and in dental practice. The elaboration is designed by a professional, a dental technician or a dentist. This quarantees their correct use, since it is an intermediate product in order to manufacture a custom-made product.

AI/ML Overview

The provided document describes the FDA 510(k) summary for a dental polymer blank device named IDODENTINE. It details the device's characteristics, intended use, and a comparison with predicate devices to establish substantial equivalence based on non-clinical testing.

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

Key Takeaway: This document does not describe a study comparing the performance of the IDODENTINE device against acceptance criteria in the way a diagnostic or AI device would be evaluated. Instead, it demonstrates substantial equivalence to predicate devices based on meeting established ISO standards for dental materials and biocompatibility through non-clinical physical and chemical testing.

1. Table of Acceptance Criteria and Reported Device Performance

Physical/Biocompatibility Parameters	ISO 10477 / ISO 20795 Requirements (Acceptance Criteria)	Predicate Device Reported Performance	IDODENTINE Reported Performance
Biocompatibility	ISO 10993	ISO 10993-5 Non cytotoxic	ISO 10993-5 Non cytotoxic (NIOM test report 025/10)
Flexural strength	≥ 50 MPa (ISO 10477), ≥ 65 MPa (ISO 20795)	91.5 MPa	90 MPa (NIOM test report 026/10)
Water absorption	≤ 0.040 mg/mm³ (ISO 10477), ≤ 0.032 mg/mm³ (ISO 20795)	0.026 mg/mm³	0.023 mg/mm³ (NIOM test report 026/10)
Water solubility	≤ 0.007.5 mg/mm³ (ISO 10477), ≤ 0.001.6 mg/mm³ (ISO 20795)	0.0002 mg/mm³	0.0000 mg/mm³ (NIOM test report 026/10)
Residual monomer content	≤ 2.2%	1%	1.4% (Innovatech GC/MS test 115201-A)

The acceptance criteria here are the requirements specified by the relevant ISO standards (ISO 10477, ISO 20795, ISO 22112, ISO 10993-5) for polymer-based dental materials. The device's performance is demonstrated to meet or exceed these requirements and be comparable to the predicate device.

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

The document does not specify a "test set" in the context of a diagnostic or AI study with patient data. The testing performed is non-clinical, involving material properties.

Sample size for non-clinical tests: Not explicitly stated as a number of distinct material samples, but rather implies that the material was tested according to ISO standard methodologies.
Data provenance: The data comes from internal testing by the manufacturer (Union Dental S.A.) and external reports from NIOM (Nordic Institute of Dental Materials) and Innovatech. This is prospective testing of the manufactured material. The country of origin for the device is Spain, and for the external testing labs, NIOM is located in Norway, and Innovatech is not specified but is a testing service.

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

N/A. This is a non-clinical material performance evaluation, not a study requiring expert readers or ground truth established by medical professionals. The "ground truth" is the established international standard (ISO) for material properties.

4. Adjudication Method

N/A. Not applicable for non-clinical material testing.

5. Multi-reader Multi-case (MRMC) Comparative Effectiveness Study

N/A. This is a non-clinical material performance evaluation, not a study evaluating human reader performance with or without AI assistance.

6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)

N/A. This is a material, not an algorithm or AI device.

7. Type of Ground Truth Used

The "ground truth" for the non-clinical tests is represented by the requirements specified in the international ISO standards (ISO 10477, ISO 20795, ISO 22112 for material properties, and ISO 10993-5 for biocompatibility). These standards define the acceptable range or minimum/maximum values for specific physical, chemical, and biological properties of the dental material.

8. Sample Size for the Training Set

N/A. This document does not describe a training set as it pertains to an AI or machine learning model. The device is a fabricated material, not a software algorithm.

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

N/A. Not applicable as there is no training set mentioned in the context of an AI/ML algorithm.

Summary

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

August 14, 2015

Union Dental S.A. José Luis Rodriguez Blanco Technical Director Paseo de la Estación, 4, 28550 Tielmes, Madrid SPAIN

Re: K150432

Trade/Device Name: IDODENTINE Dental Polymer Blank Regulation Number: 21 CFR 872.3770 Regulation Name: Temporary Crown and Bridge Resin Regulatory Class: II Product Codes: EBG, EBI, MQC Dated: April 30, 2015 Received: May 20, 2015

Dear Mr. Rodriguez Blanco:

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. Isting 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 (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/Resourcesfor You/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Erin | Keith -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

Enclosure

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Indications for Use

510(k) Number (if known) K150432

Device Name IDODENTINE (DENTAL POLYMER BLANK)

Indications for Use (Describe)

Acrylic polymer blank particularly suitable for making removable or temporary dental structures such as crowns and bridges using milling technology using CAD/CAM. Indications:

Temporary anterior and posterior crowns
Temporary anterior and posterior bridges with up to two adjacent pontics
Implant supported temporary restorations

Maximum recommended usage period: 12 months

Removable structures for dentures (dental bases)
Removable structures for therapeutic restorations (bite splints or occlusal splints)

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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To: DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION

Premarket Notification Submission (510(k)): K150432

Dental polymer blanks

5. 510(K)SUMMARY Date of Summary: April 30th 2015

1- Submitter

Union Dental S.A Company name:

Paseo de la Estación, 4 28550 - Tielmes. Madrid, Spain Address: Contact name: José Luis Rodríguez Telephone No. 00-34-91-873-76-30 00-34-91-874-64-90 Fax No. e-mail: unidesa@unidesa-odi.com

2- Device Name

Proprietary name: IDODENTINE blanks

Common name: Dental polymer blanks (discs or blocks)

3- Common or usual name and classification

Classification name: Temporary crown and bridge resin Requlation number: 872.3770 Product code: EBG, EBI, MQC Classification. Class II.

4- Predicate Device information

Predicate Device selected to demonstrate substantial equivalence

Company	Predicate Device	Intended use	510K nr
MERZ DentalGmbH	M-PM-DISC(Tooth colored)	Temporary crown andbridges	K071548

Reference predicates

Company	Predicate Device	510K nr
MERZ Dental GmbH	M-PM-DISC (Clear)	K134015
MERZ Dental GmbH	M-PM-DISC (Pink)	K140758
MERZ Dental GmbH	ART BLOCK Temp	K080556

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Image /page/4/Picture/1 description: The image shows a close-up of a white daisy with a yellow center, set against a blurred background of blue and white hues. The flower is the focal point, with its petals radiating outwards. Below the flower, the text "unidesa-odi" is visible, suggesting a logo or brand name associated with the image.

5- Devices description

6- Intended use

Acrylic polymer blank particularly suitable for making removable or temporary dental structures such as crowns and bridges using milling technology using CAD/CAM.

Indications:

Temporary anterior and posterior crowns -
-Temporary anterior and posterior bridges with up to two adjacent pontics
Implant supported temporary restorations -Maximum recommended usage period: 12 months
Removable structures for dentures (dental bases) -
Removable structures for therapeutic restorations (bite splints or occlusal splints) -

7- Technological characteristic and substantial equivalence

Chemical Composition:

device has similar chemical cocomposition as as the predicate The device. (Polymethylmetacrilate, commonly named as PMMA, the same PMMA that is used for produce acrylic teeth)

Technological characteristics:

The device has the same technological characteristics as the predicate device (Hot cured PMMA). And the device is similar in sizes, shapes and color scale as the above predicate devices. (Variable thickness milling blank (Disc or block) in Vita colours (A1, A2...), or pink or clear)

Properties:

The device has comparable physical and chemical properties as the predicate device. (Meeting the requirements of ISO standards for the polymer-based dental materials, ISO 10477, 20795, 22112)

Usage:

The device has similar indications for use as the sum of the predicate devices: Milling blank in the fabrication of temporary restorative dental prostheses such as dental crowns and bridges M-PM-DISC (Tooth colored) or removable dental structures like denture bases M-PM-DISC (Pink) and bite splints M-PM-DISC (Clear).

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Image /page/5/Picture/1 description: The image shows a close-up of a white daisy with a yellow center, set against a blurred blue background. The flower is in focus, highlighting its delicate petals and the texture of its central disc. Below the flower, the text "unidesa-odi" is visible in a small, sans-serif font, suggesting it may be a logo or watermark associated with the image.

8- Materials

Polymers based on PMMA are well established products; these products have been used as an established part of dental prosthesis techniques for over 70 years. UNION DENTAL S.A. has been manufactured this type of polymers since its foundation in 1965.

Dental polymer blanks (the subject device and predicate devices) are made with the same (powder / liguid) mix that is used for the manufacture of artificial teeth (Hot cured PMMA) and all the components of these products had been suitably considered in the bibliography. PMMA is biocompatible for this intended use.

9- Preclinical testing and standards

Clinical and Non clinical performance

ldodentine dental polymer blank has not been tested clinically. Both Idodentine and predicate devices are fabricated from the same PMMA that is used for produce acrylic teeth. This PMMA has been tested for biocompatibility and physical properties (see the biocompatibility and non -clinical testing section).

This PMMA used has been rated as biocompatible and Non toxic and this PMMA material also met the applicable requirements of ISO 10447(crown & bridges material), ISO 20795(removable dentures) and ISO 22112(polymer teeth) standards.

The subject device has passed testing according to ISO 10477/2004: DENTISTRY - POLYMER-CROWN AND BRIDGE MATERIALS. This international standard specifies BASED the classification, requirements and test methods for the polymer-based crown and bridge materials. The subject device also has passed testing according to ISO 10993-5 and has been rated as Non cytotoxic

Physicalparameters	Biocompatibility	Flexural strength	Water absorption:	Water solubility:	Residualmonomercontent:
ISO 10477ISO 20795requirements	ISO 10993	≥ 50 MPa≥ 65 MPa	≤ 0.040 mg/mm³≤ 0.032 mg/mm³	≤ 0.007.5 mg/mm³≤ 0.001.6 mg/mm³	≤ 2,2%
PREDICATE(data from technicaldocumentationofthe manufacturer)	ISO 10993-5Non cytotoxic	91.5	0.026 mg/mm³	0.0002 mg/mm³	1%
IDODENTINE	ISO10993--5Non cytotoxic(NIOM testreport 025/10)	90 MPa(NIOM testreport 026/10)	0.023 mg/mm³,(NIOM testreport 026/10)	0.0000 mg/mm³(NIOM testreport 026/10)	1,4%(InnovatechGC/MS test115201-A)

Comparison table:

Discussion of the nonclinical test submitted:

Both subject device and predicate device meet the requirements of applicable ISO standards and the results of the non-clinical testing are so similar between the device and the predicate that, taking account the error percentages of the measures and possible differences in test method(as is the case of monomer content where ISO 20795 standard allows to use different ways to calculate the final result(GC, HPLC...), we can speak about predicate and device have similar results in the non clinical testing.

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Image /page/6/Picture/0 description: The image shows a close-up of a white daisy with a yellow center. The background is a blurry mix of blue and white, creating a soft, dreamy effect. The words "unidesa-odi" are written in a small, sans-serif font at the bottom of the image.

The tests discussed above indicate that the subject device is substantially equivalent in to the predicate device.

10-Conclusions

The new and predicate devices are similar in function, and similar in composition, production technology and intended use. This supports that the applicant device is substantially equivalent to the predicate device.

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.