(83 days)
No
The device is a material blank (PMMA disc) used in CAD/CAM systems, and the description focuses on the material properties and intended use for milling temporary restorations. There is no mention of AI or ML in the device description, intended use, or performance studies.
No
The device is a material (PMMA blanks) used to mill temporary dental restorations until permanent ones are delivered. It does not directly provide therapy or treatment.
No
The device is a material (polymethyl methacrylate blanks) used for milling temporary dental restorations, not for diagnosing medical conditions.
No
The device is a physical polymethyl methacrylate blank used for milling dental restorations, not a software program.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens derived from the human body. The intended use of the PuRE PMMA Discs is to mill dental restorations, which are physical objects placed in the mouth, not used for testing biological samples.
- The description focuses on the material and its use in manufacturing dental prosthetics. There is no mention of analyzing biological samples, diagnosing conditions, or providing information about a patient's health status based on in vitro testing.
The device is a material used in a manufacturing process for dental restorations, not a diagnostic tool.
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
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 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
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.
Physical Properties met the acceptance criteria of ISO 10477:2004 and JIS T 6518:2011.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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). 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
1
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
2
Indications for Use
510(k) Number (if known)
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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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SECTION 5: 510(k) Summary
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 | July 21, 2017 |
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
Device Name: TELIO® CAD
Submitter/Applicant: Ivoclar Vivadent, Incorporated |
|--------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Reference Devices for
Composition and
Biocompatibility | 1. 510(k) No.: K151764
Device Name: Yamahachi PMMA Disks
Submitter/Applicant: Yamahachi Dental Products USA, Inc
-
510(k) No.: K132937
Device Name: Harvest Dental Polymer Blocks (ZCAD)
Submitter/Applicant: Harvest Dental Products, LLC -
510(k) No.: K973513
Device Name: ESPE Sinfony Opaquer Powder
Submitter/Applicant: ESPE GMBH & CO. KG. |
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 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 |
- K132937
- K973513 | -- |
| Applicant | Quest Dental U.S.A. Corp. | Ivoclar Vivadent | 1. Yamahachi Dental Products USA, Inc. - Harvest Dental Products, LLC
- ESPE GMBH & CO. KG. | |
| Device Name | PuRE PMMA Disc | TELIO® CAD | 1. Yamahachi PMMA Disks - Harvest Dental Polymer Blocks (ZCAD)
- ESPE Sinfony Opaquer Powder | |
| Regulation No. | 21 CFR 872.3770 | 21 CFR 872.3770 | 1. 21 CFR 872.3770 - 21 CFR 872.3770
- 21 CFR 872.3690 | The subject device is regulated the same as K093708, K151764, and K132937. |
| Product Code | EBG | EBG | 1. EBG - EBG
- 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.
5
| | restorations can be
delivered.
Restorations are
designed and
manufactured by
dental professionals
and technicians using
open CAD/CAM
technology. | | | |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|----------------|--------------------------------------------------------------------------------------------------------------------------------------|
| 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 | PMMA, pigments | The subject
device is
composed of
the same or
similar materials
used in the
predicate and
reference
devices. |
| Biocompatibility | Biocompatible | 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 | | 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.