Vitacrilic®

Basic Information

• Brand Name: Vitacrilic®
• Primary DI: B71514001025P0
• Version / Model: 14001-025P
• Catalog Number: 14001-025P
• Company Name: FRICKE INTERNATIONAL, INC.
• Labeler DUNS: 957630726
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-09-18
• Public Version: 1
• Public Version Date: 2019-09-26
• Public Version Status: New
• Public Device Record Key: 7277218c-9ba8-4283-96db-a18fb566e22c

Device Description

Blue Tray

Device Characteristics

• Single Use: Yes
• 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: 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
58106	Dental impression tray material	A material intended to be used to create a custom impression tray intended for filling with dental impression materials; it is not intended for the fabrication of a patient-worn dental appliance. The tray is typically made by applying the material to a preliminary plaster or stone model of the patient's teeth and gums. The material is used in cases in which a preformed impression tray is not suitable. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B71514001025P0	HIBCC

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Weight	25	Pound