BISICO Liquid Hardener A

Basic Information

• Brand Name: BISICO Liquid Hardener A
• Primary DI: EBIB008101
• Version / Model: 00810
• Catalog Number: 00810
• Company Name: bisico Bielefelder Dentalsilicone GmbH & Co. KG
• Labeler DUNS: 316133664
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-06-26
• Public Version: 1
• Public Version Date: 2020-07-06
• Public Version Status: New
• Public Device Record Key: e94f5462-e50f-4e24-8a3f-d50103a8e608

Device Description

Liquid hardener (catalyst) for mixing with condensation-curing impression silicones (C-silicones). The product is used in dentistry and in the laboratory.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• 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
35866	Silicone dental impression material	An elastomeric, polysiloxane-based material capable of reacting to form a rubber-like substance suitable to reproduce the structure of a patient's teeth and gums, or other oral anatomy, after being placed on an impression tray and inserted into the mouth. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	EBIB008101	HIBCC

Customer Contacts

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