Light Resin Plate

Basic Information

• Brand Name: Light Resin Plate
• Primary DI: 04582594041400
• Version / Model: 2.2mm
• Company Name: YAMAHACHI DENTAL MFG.,CO.
• Labeler DUNS: 693430001
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-08-09
• Public Version: 1
• Public Version Date: 2022-08-17
• Public Version Status: New
• Public Device Record Key: 0856752d-41df-4a83-87b5-fbb8e96d7220

Device Characteristics

• Single Use: Yes
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EBH	Material, Impression Tray, Resin	Dental	872.3670	1

GMDN Terms

Code	Name	Definition	Implantable	Status
34808	Dental base plate	A foundation on which an occlusal rim is built or a trial denture set-up. Dental base plates are made of wax, shellac or polymers and formed individually for one patient (custom-made). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04582594041400	GS1