Flexcera™ Base Ultra+ Dark Pink

Basic Information

• Brand Name: Flexcera™ Base Ultra+ Dark Pink
• Primary DI: 04260683220935
• Version / Model: RES-01-3502
• Catalog Number: RES-01-3502
• Company Name: Envisiontec GmbH
• Labeler DUNS: 332025159
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-09-13
• Public Version: 1
• Public Version Date: 2023-09-21
• Public Version Status: New
• Public Device Record Key: 08dd0b85-3d5a-4f09-8b0e-42d9a3a88ef4

Device Description

Flexcera Base Ultra+ is a light-curing material for the additive manufacturing of individual and removable full and partial 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: 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
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	872.3760	2

GMDN Terms

Code	Name	Definition	Implantable	Status
55831	Denture base resin kit	A collection of resins and other devices and/or materials intended to be used in the dental laboratory to manufacture a complete or partial denture base (the portion of a denture that rests on the oral mucosa and retains the artificial teeth). It usually includes the resin monomer (e.g., acrylic monomer of methyl methacrylate), a catalyst intended for polymerization, and additional products such as pigments, plasticizers, and/or devices (e.g., flasks, clamps). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04260683220935	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K210977	000

Storage Conditions

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