IDODENTINE DISC, IDODENTINE BLOCK

K150432 · Union Dental S.A. · EBG · Aug 14, 2015 · Dental

Device Facts

• Record ID: K150432
• Device Name: IDODENTINE DISC, IDODENTINE BLOCK
• Applicant: Union Dental S.A.
• Product Code: EBG · Dental
• Decision Date: Aug 14, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3770
• Device Class: Class 2
• Attributes: Therapeutic

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)

Device Story

IDODENTINE is a hot-cured PMMA polymer blank (disc or block) used as an intermediate material for fabricating custom dental prostheses. Input: CAD/CAM milling system data; Transformation: subtractive milling of the polymer blank into specific dental shapes; Output: temporary crowns, bridges, implant-supported restorations, denture bases, or bite splints. Used in dental laboratories or clinical settings by dentists or dental technicians. The device provides a biocompatible, temporary restorative solution; clinical benefit derived from the ability to create patient-specific provisional structures via digital workflows.

Clinical Evidence

No clinical data. Bench testing only. Performance verified via ISO 10477, ISO 20795, and ISO 22112 standards. Biocompatibility confirmed per ISO 10993-5 (non-cytotoxic). Physical testing (flexural strength, water absorption/solubility, residual monomer) demonstrates equivalence to predicate device.

Technological Characteristics

Material: Hot-cured Polymethylmethacrylate (PMMA). Form factor: Circular discs or rectangular blocks. Processing: CAD/CAM milling. Standards: ISO 10477 (crown/bridge), ISO 20795 (dentures), ISO 22112 (polymer teeth), ISO 10993-5 (biocompatibility). Connectivity: None (standalone material).

Indications for Use

Indicated for patients requiring temporary anterior/posterior crowns, bridges (up to two adjacent pontics), implant-supported temporary restorations, removable denture bases, or therapeutic bite/occlusal splints. Maximum usage period is 12 months.

Regulatory Classification

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.

Predicate Devices

• M-PM-DISC (Tooth colored) (K071548)

Reference Devices

• M-PM-DISC (Clear) (K134015)
• M-PM-DISC (Pink) (K140758)
• ART BLOCK Temp (K080556)
• ODILUX (K070591)
• ODIPAL (K070591)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/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 image of a caduceus, a symbol often associated with medicine and healthcare, featuring a staff with a serpent entwined around it.

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.

{1}------------------------------------------------

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 [phone] or [phone] 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 [phone] or [phone] 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

{2}------------------------------------------------

## 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)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW!*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows a close-up of a white daisy with a yellow center. The background is a soft, blurred blue, creating a dreamy and serene atmosphere. The words "unidesa-odi" are written in a small, sans-serif font below the flower, likely indicating a brand or organization associated with the image.

## 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: [e-mail]

## 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 Dental<br>GmbH | M-PM-DISC<br>(Tooth colored) | Temporary crown and<br>bridges | 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 |

{4}------------------------------------------------

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

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.

#### 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).

{5}------------------------------------------------

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

| Physical<br>parameters | Biocompatibility | Flexural strength | Water absorption: | Water solubility: | Residual<br>monomer<br>content: |
|-------------------------------------------------------------------------------|--------------------------------------------------------------|----------------------------------------|-----------------------------------------------|-----------------------------------------------|------------------------------------------------|
| ISO 10477<br>ISO 20795<br>requirements | ISO 10993 | ≥ 50 MPa<br>≥ 65 MPa | ≤ 0.040 mg/mm³<br>≤ 0.032 mg/mm³ | ≤ 0.007.5 mg/mm³<br>≤ 0.001.6 mg/mm³ | ≤ 2,2% |
| PREDICATE<br>(data from technical<br>documentation<br>of<br>the manufacturer) | ISO 10993-5<br>Non cytotoxic | 91.5 | 0.026 mg/mm³ | 0.0002 mg/mm³ | 1% |
| IDODENTINE | ISO10993--5<br>Non cytotoxic<br>(NIOM test<br>report 025/10) | 90 MPa<br>(NIOM test<br>report 026/10) | 0.023 mg/mm³,<br>(NIOM test<br>report 026/10) | 0.0000 mg/mm³<br>(NIOM test<br>report 026/10) | 1,4%<br>(Innovatech<br>GC/MS test<br>115201-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.

{6}------------------------------------------------

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.