(132 days)
No
The summary describes a PMMA disk used in a CAD/CAM system. While software is mentioned for creating a virtual restoration from an intraoral scan, there is no indication that this software utilizes AI or ML. The focus is on the material properties and compatibility with milling systems.
No.
A therapeutic device is one that treats or prevents a disease or condition. This device is a material used to fabricate dentures, which are prosthetic replacements and not a treatment or prevention of a disease.
No
This device, a PMMA disk, is used to fabricate dentures after a virtual restoration has been created from an intraoral scan. It is a material used in the manufacturing process of a dental prosthetic, not a tool for diagnosing medical conditions.
No
The device described is a physical PMMA disk used for milling dentures. While it is used in conjunction with software and a milling machine, the device itself is a hardware component.
Based on the provided information, the YAMAHACHI Pink CAD/CAM Disk is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "fabrication of dentures." This is a manufacturing process for a medical device (a denture), not a diagnostic test performed on a sample from the human body to provide information about a physiological state, disease, or condition.
- Device Description: The device is a material (acrylic blanks) used in a manufacturing process (CAD/CAM milling) to create a physical product (a denture). It does not interact with a biological sample for diagnostic purposes.
- Input: While it uses data from an intraoral scan, this data is used for design and manufacturing, not for analyzing a biological sample to diagnose or monitor a condition.
- Performance Studies: The performance studies focus on the physical properties of the material (flexural strength, water sorption, etc.) and compliance with standards related to dental materials, not on diagnostic accuracy or performance metrics like sensitivity or specificity.
IVD devices are typically used to test samples like blood, urine, tissue, etc., to provide diagnostic information. The YAMAHACHI Pink CAD/CAM Disk is a material used in the creation of a prosthetic device.
N/A
Intended Use / Indications for Use
Yamahachi Pink CAD/CAM Disk is used for the fabrication of dentures.
PMMA Disks are polymethyl methacrylate blanks used to mill dentures in various CAD/CAM systems.
Product codes (comma separated list FDA assigned to the subject device)
EBI
Device Description
Yamahachi PMMA Disks are acrylic blanks used in dental CAD/CAM milling systems by professional dental technicians to fabricate dentures. The restoration process begins in the dental office with an intraoral scan of the affected tooth and the surrounding teeth. Proprietary software takes this digital image and creates a replacement part for the missing areas of the tooth, creating a virtual restoration. The software sends this virtual data to a milling machine where the replacement part is carved out of a Yamahachi PMMA Disk. The optical impression system, software, and milling machine are not included in this submission.
The device is composed of hot-cured polymethyl methacrylate (PMMA) and pigments.
Yamahachi Pink Disks are available in different shapes and shades, with disks of all shades available in different dimensions (diameter, thickness and profile margin). It is intended for use in both open, closed and block type CAD/CAM systems. The circular disk model fits open milling systems, while the configurations for closed systems include Amann Girrbach, Zirkonzahn and block type can be used for any milling machine with the appropriate and compatible CAM system.
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
Professional dental 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)
Non-clinical Performance testing was conducted on the subject device according to ISO 10477:2004 for Physical Properties and met acceptance criteria. Additional testing was performed according to ISO 20795-1:2013 Dentistry - Denture base polymers, covering Appearance, Size/Diameter, Thickness, Color of Shades, Flexural Strength, Flexural Modulus, Water Sorption, Solubility, Color Stability, Translucency, and Residual MMA. The device also has a shelf life of 10 years.
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
§ 872.3760 Denture relining, repairing, or rebasing resin.
(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.
0
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Yamahachi Dental Mfg., Co. % Joyce St. Germain/Claude Berthoin Regulatory Dept. Manager/CEO Denterprise International, Inc./510k FDA Consulting 100 East Granada Blvd. Ormond Beach Florida 32176
January 16, 2018
Re: K172683
Trade/Device Name: Yamahachi Pink CAD/CAM Disk Regulation Number: 21 CFR 872.3760 Regulation Name: Denture relining, repairing, or rebasing resin Regulatory Class: Class II Product Code: EBI Dated: December 4, 2017 Received: December 7, 2017
Dear Joyce St. Germain/Claude Berthoin:
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.
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
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forTina 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 Yamahachi Pink CAD/CAM Disk
Indications for Use (Describe) Yamahachi Pink CAD/CAM Disk is used for the fabrication of dentures.
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)
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510k FDA Consulting
100 East Granada Blvd., Suite 219
Ormond Beach, FL 32176
386-506-8711
510(k) Summary
Submitter/Applicant K172683
Yamahachi Dental Mfg., Co. 54-1, Ochigara, Nishiura-Cho Gamamori-City, Aichi Pref, Japan 443-0105
| Establishment Registration: | |
|---|---|
| Phone: | +81-533-57-7121 |
| Fax: | +81-533-57-1764 |
| Primary Contact: | Shogo Muramatsu, muramatsu@yamahachi-dental.co.jp |
| Secondary Contact: | Kani Akifumi, kani@yamahachi-dental.co.jp |
Date Prepared: August 30, 2017
Preparer/Consultant
Denterprise International, Inc. 100 East Granada Blvd., Suite 219 Ormond Beach, FL 32176
| Phone: | 386-506-8711 |
|---|---|
| Primary Contact: | Joyce St. Germain, Regulatory Dept Manager, joyce@510kfda.com |
| Secondary Contact: | Claude Berthoin, CEO, claude@denterpriseintl.com |
Device Classification
| Trade Name: | Yamahachi Pink CAD/CAM Disk |
|---|---|
| Common Name: | Pink CAD/CAM Disk |
| Classification Name: | Denture relining, repairing, or rebasing resin |
| Regulation Number: | 21 CFR 872.3760 |
| Product Code: | EBI |
| Class: | 2 |
4
Predicate Device
The subject device claims equivalence to the following legally marketed predicate:
| 510(k) Number: | K153546 |
|---|---|
| Trade Name: | Pink CAD/CAM Disc |
| Manufacturer: | Polident D.O.O. |
| Regulation Number: | 21 CFR 872.3760 |
| Product Code: | EBI |
Reference Predicate Device
The following reference is a legally marketed, post-amendment device. This reference predicate is the same PMMA Disk (only the shade is different) and the same CAD/CAM system cleared that is used with the subject device.
| 510(k) Number: | K151764 |
|---|---|
| Clearance Date: | November 23, 2015 |
| Trade Name: | Yamahachi PMMA Disk |
| Manufacturer: | Yamahachi Dental Material Co., Ltd., China |
| Regulation & PC: | 872.3770; EBG |
Reference Predicate Device
The following reference is a legally marketed, post-amendment device. This reference predicate is identical chemical composition as the subject device made and cleared by Yamahachi with Resin Basis and Basis Hi devices.
| 510(k) Number: | K131036 |
|---|---|
| Clearance Date: | July 12, 2013 |
| Trade Name: | Yamahachi Denture Base Resins |
| Manufacturer: | Yamahachi Dental Mfg., Co., Japan |
| Regulation & PC: | 872.3760; EBI |
Indications for Use
YAMAHACHI Pink CAD/CAM Disk is used for the fabrication of dentures.
Intended Use
PMMA Disks are polymethyl methacrylate blanks used to mill dentures in various CAD/CAM systems.
5
Device Description
Yamahachi PMMA Disks are acrylic blanks used in dental CAD/CAM milling systems by professional dental technicians to fabricate dentures. The restoration process begins in the dental office with an intraoral scan of the affected tooth and the surrounding teeth. Proprietary software takes this digital image and creates a replacement part for the missing areas of the tooth, creating a virtual restoration. The software sends this virtual data to a milling machine where the replacement part is carved out of a Yamahachi PMMA Disk. The optical impression system, software, and milling machine are not included in this submission.
The device is composed of hot-cured polymethyl methacrylate (PMMA) and pigments.
Yamahachi Pink Disks are available in different shapes and shades, with disks of all shades available in different dimensions (diameter, thickness and profile margin). It is intended for use in both open, closed and block type CAD/CAM systems. The circular disk model fits open milling systems, while the configurations for closed systems include Amann Girrbach, Zirkonzahn and block type can be used for any milling machine with the appropriate and compatible CAM system.
Comparison of Technological Characteristics with Predicate
The following table compares technological and other characteristics of the subject and predicate device.
| Subject Device | Predicate Device | Comparison | |
|---|---|---|---|
| Device | Pink Disk | Pink CAD/CAM | |
| Disc | NA | ||
| K number | K172683 | K153546 | NA |
| 510(k) Owner | Yamahachi Dental | ||
| Mfg., Co. (Japan) | Polident D.O.O. | NA | |
| Classification & | |||
| Product Code | 872.3760; EBI | 872.3760; EBI | Same |
| Classification Name | Denture relining, | ||
| repairing, or rebasing | |||
| resin | Denture relining, | ||
| repairing, or rebasing | |||
| resin | Same | ||
| Common Name | PMMA CAD/CAM Disk | PMMA CAD/CAM Disk | Same |
| Device Description | Disks are milling blanks | ||
| used in the fabrication | |||
| of dentures. | Disks are milling blanks | ||
| used in the fabrication | |||
| of dentures | Same | ||
| Intended Use | PMMA Disks are | ||
| polymethyl | |||
| methacrylate blanks | |||
| used to mill dentures | |||
| in various CAD/CAM | Fabrication of | ||
| dentures. | Same |
Table 5 -- Technological Comparison
6
| systems. | |||
|---|---|---|---|
| Indication For Use | YAMAHACHI Pink | ||
| CAD/CAM Disk is used | |||
| in the fabrication of | |||
| dentures. | Fabrication of dentures. | Same |
Technological
| Characteristics | |||
|---|---|---|---|
| Product State | Solid | Solid | Same |
| How Device Is Made | Powder + Liquid | ||
| methacrylate-based | |||
| resins mixed together | |||
| and heat cured | Powder + Liquid | ||
| methacrylate-based | |||
| resins mixed together | |||
| and heat cured | Same | ||
| Fabrication | CAD/CAM technique | CAD/CAM technique | Same |
| General Description | Cross-linked PMMA- | ||
| based resins with | |||
| pigments for tinting | Cross-linked PMMA- | ||
| based resins with | |||
| pigments for tinting | Same | ||
| Configurations | Open--Disk; | ||
| Closed--Amann | |||
| Girrbach, Zirkonzahn, | |||
| Block, Pin & 2 Pin | Closed and Block Disc | Same | |
| Subject also available | |||
| for open disk use. | |||
| Components | PMMA with cross- | ||
| linker and pigments | PMMA with cross- | ||
| linker and pigments | Same | ||
| Biocompatibility | Previously tested and | ||
| established with FDA | |||
| with cleared device | |||
| K131036 | Predicate | ||
| Biocompatibility | |||
| complete for device | |||
| clearance | Same |
Non-clinical Performance testing
| Physical Properties | ISO 10477:2004
Met acceptance
criteria of this
standard. | ISO 10477:2004 | Same |
|---------------------|-------------------------------------------------------------------|----------------|-----------------------------------------|
| Shelf Life | 10 Years | Not determined | Subject exceeds
practical shelf life |
7
ADDITIONAL: ISO 20795-1:2013 Dentistry - Denture base polymers. The subject device was also tested on the following according to the standard:
- Appearance
- Size/Diameter (minimum to maximum) ●
- Thickness (minimum to maximum) ●
- Color of Shades
- Flexural Strength ●
- Flexural Modulus ●
- Water Sorption ●
- Solubility ●
- Color Stability
- Translucency ●
- Residual MMA
Substantial Equivalence
The above comparison chart shows the subject and predicate devices are substantially equivalent in technological characteristics.
The subject and predicate devices have the same material composition of PMMA Disks composed of polymethyl methacrylate, hot cured polymer.
The subject and predicate have the same function and the same intended use to fabricate the final products by CAD/CAM technique and have similar physical and chemical properties.
The subject and predicate are manufactured under the same technological process with the same raw material used.
The subject and predicate have both completed ISO standardized testing and have passed and the tests are in the comparison chart shown above.
Conclusion
The nonclinical tests demonstrate that the device is substantially equivalent to the predicate device since they have the same intended use, material composition, and performed as well in the physical properties testing. Therefore, Yamahachi Pink CAD/CAM Disk demonstrates that it is as safe, as effective, and performs as well as the predicate device and warrants a finding of substantial equivalence to the legally marketed predicate device.