DD poly Y ML

Basic Information

• Brand Name: DD poly Y ML
• Primary DI: EPOLKML211160
• Version / Model: KML21116
• Catalog Number: KML21116
• Company Name: POLIDENT d.o.o.
• Labeler DUNS: 644778409
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-10-02
• Public Version: 1
• Public Version Date: 2024-10-10
• Public Version Status: New
• Public Device Record Key: 794f1bef-7cf9-4d59-894d-a6c9ab5323cd

Device Description

DD poly Y ML 98 H16 C3

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: No
• 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
EBG	Crown And Bridge, Temporary, Resin	Dental	872.3770	2
ELM	Denture, Plastic, Teeth	Dental	872.3590	2

GMDN Terms

Code	Name	Definition	Implantable	Status
31783	Temporary dental crown/bridge	A prosthetic dental device intended to temporarily replace the top of a tooth or a group of teeth until a permanent restoration is fabricated. The device is typically made of plastic material [e.g., polymethylmethacrylate (PMMA)].	No	Active
38643	Resin artificial teeth	Prefabricated teeth made of polymer-based material for mounting on dentures. Teeth are normally delivered as sets of front teeth, upper or lower jaw, or sets of premolars and molars, upper or lower jaw, in various sizes, shapes and colours.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	EPOLKML211161	HIBCC	carton box	1	In Commercial Distribution
Primary	EPOLKML211160	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]