Yamahachi Pink CAD/CAM Disk

K172683 · YAMAHACHI DENTAL MFG., Co. · EBI · Jan 16, 2018 · Dental

Device Facts

• Record ID: K172683
• Device Name: Yamahachi Pink CAD/CAM Disk
• Applicant: YAMAHACHI DENTAL MFG., Co.
• Product Code: EBI · Dental
• Decision Date: Jan 16, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3760
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

PMMA Disks are polymethyl methacrylate blanks used to mill dentures in various CAD/CAM systems.

Device Story

Yamahachi Pink CAD/CAM Disk consists of hot-cured polymethyl methacrylate (PMMA) and pigments; used as milling blanks in dental CAD/CAM systems. Professional dental technicians operate the system; process begins with intraoral scan of patient's teeth; proprietary software creates virtual restoration; milling machine carves replacement part from disk. Available in various shapes, shades, and dimensions for open, closed, and block-type milling systems. Device facilitates fabrication of custom dental prosthetics; provides durable, biocompatible material for denture base applications.

Clinical Evidence

Bench testing only. No clinical data. Device performance validated against ISO 10477:2004 and ISO 20795-1:2013 standards, including testing for flexural strength, flexural modulus, water sorption, solubility, color stability, translucency, and residual MMA. Biocompatibility established via reference to previously cleared device K131036.

Technological Characteristics

Material: Hot-cured polymethyl methacrylate (PMMA) with cross-linker and pigments. Form factor: Solid disks/blocks of varying dimensions. Manufacturing: CAD/CAM milling. Standards: ISO 10477:2004, ISO 20795-1:2013. Connectivity: Compatible with open, closed (Amann Girrbach, Zirkonzahn), and block-type CAD/CAM milling systems.

Indications for Use

Indicated for the fabrication of dentures.

Regulatory Classification

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.

Predicate Devices

• Pink CAD/CAM Disc (K153546)

Reference Devices

• Yamahachi PMMA Disk (K151764)
• Yamahachi Denture Base Resins (K131036)

Submission Summary (Full Text)

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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.

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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 ([e-mail]) or phone [phone] 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

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# 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: | [phone] |
| Fax: | [phone] |
| Primary Contact: | Shogo Muramatsu, [e-mail] |
| Secondary Contact: | Kani Akifumi, [e-mail] |

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, [e-mail] |
| Secondary Contact: | Claude Berthoin, CEO, [e-mail] |

#### 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 |

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#### 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.

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#### 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<br>Disc | NA |
| K number | K172683 | K153546 | NA |
| 510(k) Owner | Yamahachi Dental<br>Mfg., Co. (Japan) | Polident D.O.O. | NA |
| Classification &<br>Product Code | 872.3760; EBI | 872.3760; EBI | Same |
| Classification Name | Denture relining,<br>repairing, or rebasing<br>resin | Denture relining,<br>repairing, or rebasing<br>resin | Same |
| Common Name | PMMA CAD/CAM Disk | PMMA CAD/CAM Disk | Same |
| Device Description | Disks are milling blanks<br>used in the fabrication<br>of dentures. | Disks are milling blanks<br>used in the fabrication<br>of dentures | Same |
| Intended Use | PMMA Disks are<br>polymethyl<br>methacrylate blanks<br>used to mill dentures<br>in various CAD/CAM | Fabrication of<br>dentures. | Same |

# Table 5 -- Technological Comparison

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| | systems. | | |
|--------------------|------------------------------------------------------------------------------|--------------------------|------|
| Indication For Use | YAMAHACHI Pink<br>CAD/CAM Disk is used<br>in the fabrication of<br>dentures. | Fabrication of dentures. | Same |

### Technological

| Characteristics | | | |
|---------------------|----------------------------------------------------------------------------------|----------------------------------------------------------------------------------|------------------------------------------------------|
| Product State | Solid | Solid | Same |
| How Device Is Made | Powder + Liquid<br>methacrylate-based<br>resins mixed together<br>and heat cured | Powder + Liquid<br>methacrylate-based<br>resins mixed together<br>and heat cured | Same |
| Fabrication | CAD/CAM technique | CAD/CAM technique | Same |
| General Description | Cross-linked PMMA-<br>based resins with<br>pigments for tinting | Cross-linked PMMA-<br>based resins with<br>pigments for tinting | Same |
| Configurations | Open--Disk;<br>Closed--Amann<br>Girrbach, Zirkonzahn,<br>Block, Pin & 2 Pin | Closed and Block Disc | Same<br>Subject also available<br>for open disk use. |
| Components | PMMA with cross-<br>linker and pigments | PMMA with cross-<br>linker and pigments | Same |
| Biocompatibility | Previously tested and<br>established with FDA<br>with cleared device<br>K131036 | Predicate<br>Biocompatibility<br>complete for device<br>clearance | Same |

## Non-clinical Performance testing

| Physical Properties | ISO 10477:2004<br>Met acceptance<br>criteria of this<br>standard. | ISO 10477:2004 | Same |
|---------------------|-------------------------------------------------------------------|----------------|-----------------------------------------|
| Shelf Life | 10 Years | Not determined | Subject exceeds<br>practical shelf life |

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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.