BITE RIM STICK

Basic Information

• Brand Name: BITE RIM STICK
• Primary DI: D080XXBRM09KG50LGP0
• Version / Model: 50PCS,S,LIGHT 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: 2021-04-29
• Public Version: 2
• Public Version Date: 2023-10-02
• Public Version Status: Update
• Public Device Record Key: 82388274-a387-4e36-9f96-48e67c4ed170

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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EGD	Wax, Dental, Intraoral	Dental	872.6890	1

GMDN Terms

Code	Name	Definition	Implantable	Status
38602	Bite registration rim wax	A dental material (modelling wax) with or without reinforcing foils (metal, polymer) for registration of jaw relation (making bite rims). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D080XXBRM09KG50LGP0	HIBCC
Secondary	04582275712452	GS1