Who is the manufacturer of YAMAHACHI PMMA DISKS?

Yamahachi Dental Products USA, Inc. filed the 510(k) submission for YAMAHACHI PMMA DISKS (K151764).

What is the FDA product code for YAMAHACHI PMMA DISKS?

EBG. It is classified under 21 CFR 872.3770 as a Class 2 device in the Dental panel.

What is the regulatory pathway for YAMAHACHI PMMA DISKS?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like YAMAHACHI PMMA DISKS?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

YAMAHACHI PMMA DISKS

K151764 · Yamahachi Dental Products USA, Inc. · EBG · Nov 23, 2015 · Dental

Device Facts

Record ID	K151764
Device Name	YAMAHACHI PMMA DISKS
Applicant	Yamahachi Dental Products USA, Inc.
Product Code	EBG · Dental
Decision Date	Nov 23, 2015
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3770
Device Class	Class 2
Attributes	Therapeutic

Intended Use

YAMAHACHI PMMA DISKS 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.

Device Story

Yamahachi PMMA Disks are hot-cured polymethyl methacrylate (PMMA) acrylic blanks; used by dental technicians in CAD/CAM milling systems to fabricate temporary crowns and bridges. Process: intraoral scan of patient tooth; proprietary software creates virtual restoration; milling machine carves restoration from PMMA disk. Finished prosthesis polished, adjusted in patient mouth, and cemented/bonded. Device remains in place until permanent restoration available. Available in various shapes/shades for open and closed milling systems (Amann Girrbach, Zirkonzahn, block, pin, 2-pin). Benefits: provides durable, aesthetic temporary restoration during interim period.

Clinical Evidence

Bench testing only. Device performance evaluated against ISO 10477:2004 standards for physical properties. Results demonstrate compliance with acceptance criteria and equivalence to predicate device.

Technological Characteristics

Material: Hot-cured cross-linked polymethyl methacrylate (PMMA) with pigments. Form factor: Disks, blocks, pins. Compatibility: Open and closed CAD/CAM milling systems. Standard: ISO 10477:2004 (Type 2, Class 1).

Indications for Use

Indicated for patients requiring long-term temporary crowns and bridges until permanent restorations can be delivered.

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

Telio CAD (K093708)

Related Devices

K172683 — Yamahachi Pink CAD/CAM Disk · YAMAHACHI DENTAL MFG., Co. · Jan 16, 2018
K112967 — PMMA CAD/CAM DISC · Polident D.O.O., Dental Products Industry · Aug 28, 2012
K172281 — PuRE PMMA Disc · Quest Dental USA Corp. · Oct 19, 2017
K122025 — BRIGHTGLASS BRIGHTGLASS M · Ktk Medical Supplies GmbH · Oct 9, 2012
K201563 — PuRE PMMA Disc · Quest Dental USA Corp. · Apr 9, 2021

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, layered on top of each other, creating a sense of depth and unity. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 November 23, 2015 Yamahachi Dental Products USA, Inc. c/o Mr. Claude Berthoin Denterprise International, Inc. 100 East Granada Blvd., Suite 219 Ormand Beach, FL 32176 Re: K151764 Trade/Device Name: Yamahachi PMMA Disks Regulation Number: 21 CFR 872.3770 Regulation Name: Temporary Crown and Bridge Resin Regulatory Class: II Product Code: EBG Dated: October 14, 2015 Received: October 16, 2015 Dear Mr. 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 (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. 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 at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 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 yours, Tina Kiang - for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ## Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page. 510(k) Number (if known) K151764 Device Name Yamahachi PMMA DISKS Indications for Use (Describe) Y AMAHACHI PMMA DISKS 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. Type of Use (Select one or both, as applicable) x Prescription Use (Part 21 CFR 801 Subpart D) ] Over-The-Counter Use (21 CFR 807 Subpart C) #### PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED. #### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) {3}------------------------------------------------ This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ # 510(k) Summary #### Submitter/Applicant Yamahachi Dental Products USA, Inc. 160 Park Avenue Nutley, NJ 07110 Phone: 973-320-2909 Fax: 973-320-2995 Contact: Lawrence G. Greenwald (Yamahachi1 @yahoo.com) Date Prepared: June 23, 2015 #### Preparer/Consultant Denterprise International, Inc. 100 East Granada Blvd., Suite 219 Ormond Beach, FL 32176 Phone: 386-672-0450 eFax: 855-235-7902 Contact Person: Joyce St. Germain, Regulatory Executive #### Device Classification | Trade Name: | Yamahachi PMMA Disks | |----------------------|----------------------------------| | Common Name: | PMMA Disks | | Classification Name: | Temporary Crown and Bridge Resin | | Regulation Number: | 21 CFR 872.3770 Class II | | Product Code: | EBG | ### Predicate Device The subject device claims equivalence to the following legally marketed predicate: | 510(k) Number: | K093708 | |--------------------|-------------------------------------------| | Trade Name: | Telio CAD | | Manufacturer: | Ivoclar Vivadent, Inc. (Amherst, NY, USA) | | Regulation Number: | 21 CFR 872.3770 | | Product Code: | EBG | #### Indictions for Use YAMAHACHI PMMA DISKS are polymethyl methacrylate blanks used to mill dental longterm temporary crowns and bridges in various CAD/CAM systems until permanent restorations can be delivered. {5}------------------------------------------------ ## Device Description Yamahachi PMMA Disks are acrylic blanks used in dental CAD/CAM milling systems by professional dental technicians to fabricate temporary crowns and bridges. After polishing, the prosthesis is adjusted in the patient's mouth and cemented or bonded in place, where it remains until removal when the permanent restoration is available. 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 part of the device. The device is composed of hot-cured polymethyl methacrylate (PMMA) and pigments. Yamahachi PMMA 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 and closed CAD/CAM systems. The circular disk model fits open milling systems, while the configurations for closed systems include Amann Girrbach, Zirkonzahn, block, pin and 2-pin. ### 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 | PMMA Disk | Telio CAD | NA | | 510(k) Owner | Yamahachi Dental Products (USA) | Ivoclar Vivadent (Germany) | NA | | Classification & Product Code | 872.3770; EBG | 872.3770; EBG | Same | | Device Description | Temporary Crown And Bridge Resin | Temporary Crown And Bridge Resin | Same | | Common Name | PMMA Disk | PMMA Disk | Same | | Intended Use | Milling blanks for fabrication of long- term temporary crowns & bridges in CAD/CAM systems. | Milling blanks for fabrication of long- term temporary crowns & bridges in CAD/CAM systems. | Same | ## Table 5 -- Technological Comparison {6}------------------------------------------------ | Indication For Use | YAMAHACHI PMMA DISKS 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. | For the fabrication of temporary crowns and bridges using CAD/CAM technology until permanent restoration can be delivered. | 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 | | General Description | Cross-linked PMMA- based resins with pigments for tinting | Cross-linked PMMA- based resins with pigments for tinting | Same | | Configurations | Open--Disc; Closed-- Amann Girrbach, Zirkonzahn, Block, Pin & 2 Pin | Closed--Block, Disc | Subject used in open as well as closed systems; not a meaningful difference. | | Components | PMMA with cross- linker and pigments | PMMA with cross- linker and pigments | Same | ### Non-clinical Performance testing | Physical Properties | ISO 10477:2004 Met acceptance criteria of this standard. | ISO 10477:2004 | Same | |-------------------------------|----------------------------------------------------------------------|----------------------------------------------------------------------|-----------------------------------------| | Classification (ISO 10477) | Type 2, Class 1 (Heat Cure Without Photo- Sensitive Initiator) | Type 2, Class 1 (Heat Cure Without Photo- Sensitive Initiator) | Same | | Shelf Life | 10 Years | Not determined | Subject exceeds practical shelf life | The above comparison shows the subject and predicate devices have substantially similar technology characteristics. {7}------------------------------------------------ #### Conclusion The nonclinical tests demonstrate that the device is substantially equivalent to predicate device since they have the same intended use, material composition, and performed as well in physical properties testing; therefore, Yamahachi PMMA Disks warrants a finding of substantial equivalence to the legally marketed predicate device.