YAMAHACHI PMMA DISK

Basic Information

• Brand Name: YAMAHACHI PMMA DISK
• Primary DI: 04582275718874
• Version / Model: 98.5mm*20mm, V PINK
• Company Name: YAMAHACHI DENTAL MFG.,CO.
• Labeler DUNS: 693430001
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-06-01
• Public Version: 2
• Public Version Date: 2018-07-06
• Public Version Status: New
• Public Device Record Key: 854a81ea-b3b8-43ed-88c2-69e6cadb1cd0

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	872.3760	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62816	Dental prosthesis fabrication material, polymer	A dental material made of a synthetic polymer [e.g., polyetheretherketone (PEEK)] intended to be used to manufacture a final dental prosthesis (e.g., a dental implant, removable dentures, crown, bridge) for patient use. It is used to create implantable and removable restorations using computer-aided design/computer-aided manufacturing (CAD/CAM) technology.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04582275718874	GS1

Premarket Submissions

Submission Number	Supplement Number
K172683	000