PuRE PMMA Disc

K172281 · Quest Dental USA Corp. · EBG · Oct 19, 2017 · Dental

Device Facts

• Record ID: K172281
• Device Name: PuRE PMMA Disc
• Applicant: Quest Dental USA Corp.
• Product Code: EBG · Dental
• Decision Date: Oct 19, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3770
• Device Class: Class 2

Intended Use

PuRE PMMA Discs are polymethyl methacrylate blanks used to mill dental long-term temporary crowns and bridges in various CAD/CAM systems until permanent restorations can be delivered. Restorations are designed and manufactured by dental professionals and technicians using open CAD/CAM technology.

Device Story

PuRE PMMA Discs are polymethyl methacrylate (PMMA) blanks used by dental professionals and technicians to fabricate long-term temporary crowns and bridges. The device is processed via milling in open CAD/CAM systems. The discs are provided non-sterile and are intended for single-use. The resulting restorations serve as temporary replacements until permanent restorations are available. The device is available in various shades and thicknesses.

Clinical Evidence

Bench testing only. The device met acceptance criteria for physical properties per ISO 10477:2004 and JIS T 6518:2011. Biocompatibility is established through comparison to predicate and reference devices.

Technological Characteristics

Material: Polymethyl methacrylate (PMMA) and pigments. Form factor: Discs (14-30 mm thickness). Manufacturing: Heat-cured powder and liquid methacrylate-based resins. Standards: ISO 10477:2004, JIS T 6518:2011. Non-sterile, single-use.

Indications for Use

Indicated for dental professionals and technicians to mill long-term temporary crowns and bridges using CAD/CAM systems until permanent restorations are delivered.

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

• TELIO® CAD (K093708)

Reference Devices

• Yamahachi PMMA Disks (K151764)
• Harvest Dental Polymer Blocks (ZCAD) (K132937)
• ESPE Sinfony Opaquer Powder (K973513)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Quest Dental USA Corp. % Takahiro Haruyama President Globizz Corporation 1411 W 190th St Gardena, California 90248

Re: K172281 Trade/Device Name: PuRE PMMA Disc Regulation Number: 21 CFR 872.3770 Regulation Name: Temporary Crown And Bridge Resin Regulatory Class: Class II Product Code: EBG Dated: August 3, 2017 Received: August 4, 2017

Dear Takahiro Haruyama:

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.

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 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.

U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.qov

October 19, 2017

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education (DICE) at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Mary S. Runner -S

for Tina Kiang, Ph.D. Acting 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)

K172281

Device Name PuRE PMMA Disc

#### Indications for Use (Describe)

PuRE PMMA Discs are polymethyl methacrylate blanks used to mill dental long-term temporary crowns and bridges in various CAD/CAM systems until permanent restorations can be delivered. Restorations are designed and manufactured by dental professionals and technicians using open CAD/CAM technology.

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size: 20px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="font-size: 20px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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# SECTION 5: 510(k) Summary

# 5.1: Submitter Information

| 510(k) Owner/Applicant | Quest Dental USA Corp<br>17865 Sky Park Circle, Ste. L1<br>Irvine, CA 92614 |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Correspondent | Takahiro Haruyama<br>Globizz Corporation<br>1411 W. 190th St., Ste. 200<br>Gardena, CA 90248<br>Tel: [phone]<br>Email: [e-mail] |
| Date Prepared | July 21, 2017 |

K172281

## 5.2: Device Identification

| Trade Name | PuRE PMMA Disc |
|---------------------------|----------------------------------|
| Common Name | PMMA Disc |
| Classification Name | Temporary Crown and Bridge Resin |
| Classification Regulation | 872.3770 |
| Review Panel | Dental |
| Product Code | EBG |
| Device Class | Class II |

## 5.3: Predicate and Reference Devices

| Predicate Device | 510(k) No.: K093708<br>Device Name: TELIO® CAD<br>Submitter/Applicant: Ivoclar Vivadent, Incorporated |
|--------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Reference Devices for<br>Composition and<br>Biocompatibility | 1. 510(k) No.: K151764<br>Device Name: Yamahachi PMMA Disks<br>Submitter/Applicant: Yamahachi Dental Products USA, Inc<br><br>2. 510(k) No.: K132937<br>Device Name: Harvest Dental Polymer Blocks (ZCAD)<br>Submitter/Applicant: Harvest Dental Products, LLC<br><br>3. 510(k) No.: K973513<br>Device Name: ESPE Sinfony Opaquer Powder<br>Submitter/Applicant: ESPE GMBH & CO. KG. |

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### 5.4: Device Description

PuRE PMMA Discs are polymethyl methacrylate blanks used to mill dental long-term temporary crowns and bridges in various CAD/CAM systems until permanent restorations can be delivered. Restorations are designed and manufactured by dental professionals and technicians using open CAD/CAM technology. The discs are provided non-sterile, without any accessories, and are indicated for single-use only.

The device is composed of polymethyl methacrylate and pigments. PuRE PMMA discs are available in 23 shades and varying thicknesses (14-30 mm):

| Clear | | | | | | |
|-------|-----|-----|-----|------|-----|-----|
| A0 | A1 | A2 | A3 | A3.5 | A4 | |
| | B1 | B2 | B3 | | B4 | |
| | C1 | C2 | C3 | | C4 | |
| | | D2 | D3 | | D4 | |
| | BL1 | BL2 | BL3 | | BL4 | BL5 |

### 5.5: Indications for Use Statement

PuRE PMMA Discs are polymethyl methacrylate blanks used to mill dental long-term temporary crowns and bridges in various CAD/CAM systems until permanent restorations can be delivered. Restorations are designed and manufactured by dental professionals and technicians using open CAD/CAM technology.

## 5.6: Comparison of Device Characteristics

| | Subject Device | Predicate Device | Reference Devices | Comparison |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|
| 510(k) No. | Not yet assigned | K093708 | 1. K151764<br>2. K132937<br>3. K973513 | -- |
| Applicant | Quest Dental U.S.A. Corp. | Ivoclar Vivadent | 1. Yamahachi Dental Products USA, Inc.<br>2. Harvest Dental Products, LLC<br>3. ESPE GMBH & CO. KG. | |
| Device Name | PuRE PMMA Disc | TELIO® CAD | 1. Yamahachi PMMA Disks<br>2. Harvest Dental Polymer Blocks (ZCAD)<br>3. ESPE Sinfony Opaquer Powder | |
| Regulation No. | 21 CFR 872.3770 | 21 CFR 872.3770 | 1. 21 CFR 872.3770<br>2. 21 CFR 872.3770<br>3. 21 CFR 872.3690 | The subject device is regulated the same as K093708, K151764, and K132937. |
| Product Code | EBG | EBG | 1. EBG<br>2. EBG<br>3. EBF | |
| Indications for use | PuRE PMMA Discs are polymethyl methacrylate blanks used to mill dental long-term temporary crowns and bridges in various CAD/CAM systems until permanent | For the fabrication of temporary crowns and bridges using the CAD/CAM technology until the permanent restoration can be delivered. | | Same. |

Table 5-A. Comparison of device characteristics to predicate and reference devices.

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| | restorations can be<br>delivered.<br>Restorations are<br>designed and<br>manufactured by<br>dental professionals<br>and technicians using<br>open CAD/CAM<br>technology. | | | |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|----------------|--------------------------------------------------------------------------------------------------------------------------------------|
| Technological<br>Characteristics | | | | |
| How Device is<br>Made | Powder and liquid<br>methacrylate-based<br>resins mixed together<br>and heat cured | Powder and liquid<br>methacrylate-based<br>resins mixed together<br>and heat cured | | Same. |
| Composition | PMMA + pigments | PMMA + pigments | PMMA, pigments | The subject<br>device is<br>composed of<br>the same or<br>similar materials<br>used in the<br>predicate and<br>reference<br>devices. |
| Biocompatibility | Biocompatible | Biocompatible | Biocompatible | Same. |
| Physical<br>Properties | Met the acceptance<br>criteria of ISO<br>10477:2004 and JIS<br>T 6518:2011. | Met the acceptance<br>criteria of ISO<br>10477:2004 | | Same. |

## 5.7: Statement of Substantial Equivalence

The subject and predicate devices are similar in intended use, technological characteristics, and composition of construction materials. Standardized performance and biocompatibility assessments, as well as differences between the devices, did not raise any new concerns regarding safety and effectiveness. The conclusions drawn from the non-clinical performance tests demonstrate that the PuRE PMMA Disc is substantially equivalent to the referenced predicate device.