BioHPP TU for2press - 20 g

Basic Information

• Brand Name: BioHPP TU for2press - 20 g
• Primary DI: EBRE54TF2PB60
• Version / Model: 54TF2PB6
• Catalog Number: 54TF2PB6
• Company Name: bredent GmbH & Co. KG
• Labeler DUNS: 341086190
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-20
• Public Version: 3
• Public Version Date: 2023-12-06
• Public Version Status: Update
• Public Device Record Key: ec2587a7-7b1c-4be2-ad70-23ae973effde
• Distribution End Date: 2023-12-04

Device Description

BioHPP TU for2press - 20 g 5 pellets of 4 g each 1 VPE

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: 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
EBF	MATERIAL, TOOTH SHADE, RESIN	Dental	872.3690	2

GMDN Terms

Code	Name	Definition	Implantable	Status
37542	Dental bridge, polymer	A custom-made, non-removable, artificial replacement for one or more missing teeth made entirely of polymer-based material, with or without fibre reinforcement, and comprised of an artifical tooth/teeth and crowns. It is fixed to abutment/adjacent teeth, tooth roots, or dental implants. Also referred to as a fixed partial prosthesis or a fixed partial denture.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	EBRE54TF2PB69	HIBCC	dummy	1	Not in Commercial Distribution	2016-09-20
Primary	EBRE54TF2PB60	HIBCC

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: keep out of sunlight
• Type: Special Storage Condition, Specify
• Special Conditions: keep dry