flow.sil Assortment

Basic Information

• Brand Name: flow.sil Assortment
• Primary DI: EBRE540012700
• Version / Model: 54001270
• Catalog Number: 54001270
• Company Name: bredent GmbH & Co. KG
• Labeler DUNS: 341086190
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-09-07
• Public Version: 1
• Public Version Date: 2023-09-15
• Public Version Status: New
• Public Device Record Key: 0c2f5069-c7e4-428c-a7eb-596df55ad54b

Device Description

flow.sil Assortment 10 parts 1 Assortment

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: 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
EFX	PROTECTOR, SILICATE	Dental	872.6670	1

GMDN Terms

Code	Name	Definition	Implantable	Status
17610	Denture reliner, soft, professional	A denture relining material used in dentistry by a dentist or dental laboratory technician that is applied as a permanent coating or lining on the base or tissue-contacting surface of a denture and which sets to a soft, plastic condition. Denture relining is defined as a process of providing a new fitting surface to a denture (ISO 1942-2, def 2.111). After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	EBRE540012709	HIBCC	dummy	1	Not in Commercial Distribution	2023-09-07
Primary	EBRE540012700	HIBCC

Customer Contacts

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