PRIMODENT

Basic Information

• Brand Name: PRIMODENT
• Primary DI: EPOLPRIT1ZG2
• Version / Model: PRI.T1ZG2
• Catalog Number: PRI.T1ZG2
• Company Name: POLIDENT d.o.o.
• Labeler DUNS: 644778409
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-06-14
• Public Version: 1
• Public Version Date: 2021-06-22
• Public Version Status: New
• Public Device Record Key: afe0a065-a93b-443f-935b-ba2025502ee4

Device Description

Resin Artificial Teeth

Device Characteristics

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Dry Heat Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ELM	Denture, plastic, teeth	Dental	872.3590	2

GMDN Terms

Code	Name	Definition	Implantable	Status
17845	Partial denture	A custom-made, removeable, artificial replacement for one or more, but not all, teeth in the lower or upper jaw (mandible or maxilla) in a partially edentulous patient. It typically includes clasps of metal or plastic that clip onto remaining teeth for retention and stabilization. It can be made of a variety of materials including polymers [polymethylmethacrylate (PMMA), polycarbonate (PC)], acrylic, ceramics, and/or metals [e.g., base metal alloys or titanium (Ti)]. Also known as a removable partial denture (RPD).	No	Active
38595	Custom-made dental crown, polymer	A device made entirely of polymer-based material with or without fibre reinforcement, and created for a specific post-pubescent/adult patient (custom-made), that functions as an artificial covering to replace the major part, or the whole part, of the clinical crown of a tooth.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	EPOLPRIT1ZG203	HIBCC	plastic card	1	Not in Commercial Distribution	2021-06-14
Primary	EPOLPRIT1ZG2	HIBCC

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Size text
Outer Diameter	3	Meter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: keep out of sunlight
• Type: Storage Environment Temperature
• Temperature Range: -30 – 40 Degrees Celsius