Flexcera Smile B1

Basic Information

• Brand Name: Flexcera Smile B1
• Primary DI: 04260683220324
• Version / Model: RES-01-3138
• Catalog Number: RES-01-3138
• Company Name: Envisiontec GmbH
• Labeler DUNS: 332025159
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-04-19
• Public Version: 2
• Public Version Date: 2021-06-30
• Public Version Status: Update
• Public Device Record Key: 6edcb303-e006-44dd-861f-96b8774dd504

Device Description

Flexcera Smile is a light-curing material for the additive manufacturing of artificial teeth for denture bases.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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
PZY	Additively Manufactured, Preformed, Resin Denture Tooth	Dental	872.3590	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38643	Resin artificial teeth	Prefabricated teeth made of polymer-based material for mounting on dentures. Teeth are normally delivered as sets of front teeth, upper or lower jaw, or sets of premolars and molars, upper or lower jaw, in various sizes, shapes and colours.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04260683220324	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Protect from sunlight
• Type: Handling Environment Temperature
• Temperature Range: 41 – 86 Degrees Fahrenheit