(303 days)
No
The device description and intended use clearly state that the device is a material (PMMA discs) used in CAD/CAM systems for milling dental restorations. There is no mention of any software, algorithms, or data processing that would involve AI or ML. The design and manufacturing are performed by dental professionals using standard CAD/CAM technology.
No.
The device is a material (PMMA blanks) used to fabricate temporary dental restorations, not a device directly used for therapy like administering medication or performing a medical procedure. Its purpose is to create a physical dental prosthetic.
No
The device is a material (PMMA blanks) used to mill temporary crowns and bridges, not to diagnose a medical condition.
No
The device description clearly states that the device is composed of polymethyl methacrylate and pigments, which are physical materials, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to mill dental long-term temporary crowns and bridges. This is a manufacturing process for a medical device that is placed in the mouth, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device is a blank material (polymethyl methacrylate discs) used in a manufacturing process. It does not contain reagents, calibrators, or controls typically associated with IVDs.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
IVDs are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device is a material used to create a physical restoration for the mouth.
N/A
Intended Use / 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 restorations can be delivered. Restorations are designed and manufactured by dental professionals and technicians using open CAD/CAM technology.
Product codes (comma separated list FDA assigned to the subject device)
EBG
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental professionals and technicians
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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. The device met the acceptance criteria of ISO 10477:2004 and JIS T 6518:2011 for Physical Properties.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
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
1
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 (1-800-638-2041 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)
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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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5. 510(k) Summary - K201563
5.1. Submitter Information
| 510(k)
Owner/Applicant | Quest Dental USA Corp
17865 Sky Park Circle, Ste. L1
Irvine, CA 92614 |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| Official
Correspondent | Takahiro Haruyama
Globizz Corporation
1411 W. 190th St., Ste. 200
Gardena, CA 90248
Tel: (310) 538-3860
Email: register@globizz.net |
| Date Prepared | May 15, 2020 |
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
| Primary
Predicate | 510(k) No.: K172281
Device Name: PuRE PMMA Disc
Submitter/Applicant: Quest Dental USA Corp. |
|--------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
| Reference
Devices for
Composition
and
Biocompatibility | 510(k) No.: K172281
Device Name: PuRE PMMA Disc
Submitter/Applicant: Quest Dental USA Corp. |
4
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
5
| Subject Device | Predicate Device | Comparison | |
|---|---|---|---|
| 510(k) No. | K201563 | K172281 | |
| Applicant | Quest Dental U.S.A. | ||
| Corp. | Quest Dental USA | ||
| 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 | |||
| 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. | 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. | Same. | ||
| Technological | |||
| Characteristics | |||
| How Device is | |||
| Made | Powder and liquid | ||
| methacrylate-based | |||
| resins mixed | |||
| together, and heat | |||
| cured | Powder and liquid | ||
| methacrylate-based | |||
| resins mixed | |||
| together, and heat | |||
| cured | Same. | ||
| Composition | PMMA + pigments | PMMA + pigments | Same |
| Biocompatibility | Biocompatible | Biocompatible | Same. |
| Physical | |||
| Properties | Met the acceptance | ||
| criteria of ISO | |||
| 10477:2004 and JIS | |||
| T 6518:2011 | Met the acceptance | ||
| criteria of ISO | |||
| 10477:2004 and JIS | |||
| 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.