PuRE PMMA Disc

K201563 · Quest Dental USA Corp. · EBG · Apr 9, 2021 · Dental

Device Facts

• Record ID: K201563
• Device Name: PuRE PMMA Disc
• Applicant: Quest Dental USA Corp.
• Product Code: EBG · Dental
• Decision Date: Apr 9, 2021
• Decision: SESE
• Submission Type: Special
• 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 as raw material for milling dental long-term temporary crowns and bridges. Dental professionals and technicians use open CAD/CAM systems to design and mill the discs into final restorations. The device is provided non-sterile and is intended for single use. The resulting temporary restorations serve as placeholders until permanent restorations are ready, benefiting patients by maintaining aesthetics and function during the interim period.

Clinical Evidence

Bench testing only. Performance and biocompatibility assessments met the acceptance criteria of ISO 10477:2004 and JIS T 6518:2011.

Technological Characteristics

Material: Polymethyl methacrylate (PMMA) and pigments. Form factor: Discs with 14-40mm thickness. Manufacturing: Heat-cured methacrylate-based resin. Standards: ISO 10477:2004, JIS T 6518:2011. Non-sterile, single-use.

Indications for Use

Indicated for dental patients requiring long-term temporary crowns and bridges until permanent restorations are delivered. Designed for use by dental professionals and technicians.

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

• PuRE PMMA Disc (K172281)

Submission Summary (Full Text)

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April 9, 2021

Quest Dental USA Corp. % Takahiro Haruyama President Globizz Corporation 1411 W. 190th Street Suite 200 Gardena, California 90248

Re: K201563

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: January 13, 2021 Received: January 13, 2021

Dear Takahiro Haruyama:

We have reviewed vour 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@)tda.hhs.gov) or phone [phone] or 301-796-7100).

Sincerely.

# Michael E. Adjodha -S

Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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#### Indications for Use

510(k) Number (if known)

K201563

Device Name PuRE PMMA Discs

Indications for Use (Describe)

Pure PMMA Discs are polymethy] 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> <svg class="bi bi-check-square" fill="currentColor" height="1em" viewbox="0 0 16 16" width="1em" xmlns="http://www.w3.org/2000/svg"> <path d="M14 1H2a1 1 0 0 0-1 1v12a1 1 0 0 0 1 1h12a1 1 0 0 0 1-1V2a1 1 0 0 0-1-1zM2 0a2 2 0 0 0-2 2v12a2 2 0 0 0 2 2h12a2 2 0 0 0 2-2V2a2 2 0 0 0-2-2H2z" fill-rule="evenodd"></path> <path d="M10.97 4.97a.75.75 0 0 1 1.071 1.05l-3.992 4.99a.75.75 0 0 1-1.08.02L4.324 8.384a.75.75 0 1 1 1.06-1.06l2.094 2.093 3.473-4.425a.236.236 0 0 1 .02-.022z" fill-rule="evenodd"></path> </svg> </span> <span>Prescription Use (Part 21 CFR 801 Subpart D)</span> </div> | <div> <span> <svg class="bi bi-square" fill="currentColor" height="1em" viewbox="0 0 16 16" width="1em" xmlns="http://www.w3.org/2000/svg"> <path d="M14 1H2a1 1 0 0 0-1 1v12a1 1 0 0 0 1 1h12a1 1 0 0 0 1-1V2a1 1 0 0 0-1-1zM2 0a2 2 0 0 0-2 2v12a2 2 0 0 0 2 2h12a2 2 0 0 0 2-2V2a2 2 0 0 0-2-2H2z" fill-rule="evenodd"></path> </svg> </span> <span>Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> |

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## 5. 510(k) Summary - K201563

### 5.1. Submitter Information

| 510(k)<br>Owner/Applicant | Quest Dental USA Corp<br>17865 Sky Park Circle, Ste. L1<br>Irvine, CA 92614 |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| Official<br>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 | May 15, 2020 |

#### 5.2. Device Identification

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

#### 5.3. Predicate and Reference Devices

| Primary<br>Predicate | 510(k) No.: K172281<br>Device Name: PuRE PMMA Disc<br>Submitter/Applicant: Quest Dental USA Corp. |
|--------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
| Reference<br>Devices for<br>Composition<br>and<br>Biocompatibility | 510(k) No.: K172281<br>Device Name: PuRE PMMA Disc<br>Submitter/Applicant: Quest Dental USA Corp. |

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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 Monochromatic colors and 20 multilayer colors all with varying thickness (14-40mm):

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

Table 1: PuRE PMMA Disc Monochromatic colors

| | | Table 2: PuRE PMMA Discs MultiLayer shade combinations |
|--|--|--------------------------------------------------------|
|--|--|--------------------------------------------------------|

| MLA1 | MLA2 | MLA3 | MLA3.5 | MLA4 |
|-------|-------|-------|--------|-------|
| MLB1 | MLB2 | MLB3 | | MLB4 |
| MLC1 | MLC2 | MLC3 | | MLC4 |
| | MLD2 | MLD3 | | MLD4 |
| MLBL1 | MLBL2 | MLBL3 | | MLBL4 |

#### 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

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| | Subject Device | Predicate Device | Comparison |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| 510(k) No. | K201563 | K172281 | |
| Applicant | Quest Dental U.S.A.<br>Corp. | Quest Dental USA<br>Corp. | -- |
| Device Name | PuRE PMMA Disc | PuRE PMMA Disc | -- |
| Regulation No. | 21 CFR 872.3770 | 21 CFR 872.3770 | Same |
| Product Code | EBG | EBG | |
| Indications for<br>use | PuRE PMMA Discs<br>are polymethyl<br>methacrylate blanks<br>used to mill dental<br>long-term temporary<br>crowns and bridges<br>in various<br>CAD/CAM systems<br>until permanent<br>restorations can be<br>delivered.<br>Restorations are<br>designed and<br>manufactured by<br>dental professionals<br>and technicians<br>using open<br>CAD/CAM<br>technology. | PuRE PMMA Discs<br>are polymethyl<br>methacrylate blanks<br>used to mill dental<br>long-term temporary<br>crowns and bridges<br>in various<br>CAD/CAM systems<br>until permanent<br>restorations can be<br>delivered.<br>Restorations are<br>designed and<br>manufactured by<br>dental professionals<br>and technicians<br>using open<br>CAD/CAM<br>technology. | Same. |
| Technological<br>Characteristics | | | |
| How Device is<br>Made | Powder and liquid<br>methacrylate-based<br>resins mixed<br>together, and heat<br>cured | Powder and liquid<br>methacrylate-based<br>resins mixed<br>together, and heat<br>cured | Same. |
| Composition | PMMA + pigments | PMMA + pigments | Same |
| Biocompatibility | 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 and JIS<br>T 6518:2011 | Same. |

Table 3: Comparison of device characteristics to predicate and reference devices.

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#### 5.7. Statement of Substantial Equivalence

The subject device and predicate devices are similar in their 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.