BD Impress

Basic Information

• Brand Name: BD Impress
• Primary DI: 07290110501969
• Version / Model: White 200gr.
• Catalog Number: 1032126
• Company Name: PERFLEX LTD
• Labeler DUNS: 532176000
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-03-14
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 6e6d028c-2755-46f0-9bb6-b0ea0898960c

Device Description

Thermoplastic pellets softens within dip hot water for bite registrations,Anterior bite stops,,Custom impression material,Customs impression tray,Bleaching trays,Build walls of impressions,Orthopedic appliances. Color White 200gr. net jar

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• 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
34799	Composite dental impression material	A thermoplastic material designed 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. It is composed of a mixture of natural resins, fillers, and lubricants. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07290110501969	GS1

Customer Contacts

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