V-Print c&b temp

Basic Information

• Brand Name: V-Print c&b temp
• Primary DI: E22168971
• Version / Model: 6897
• Catalog Number: 6897
• Company Name: VOCO GmbH
• Labeler DUNS: 316699578
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-08-04
• Public Version: 1
• Public Version Date: 2023-08-14
• Public Version Status: New
• Public Device Record Key: c269624b-a742-431f-a33f-7d6af4d54ee3

Device Description

V-Print c&b temp is a light-curing resin for the generative production of highly aesthetic temporaries / long-term temporaries in the CAD/CAM technology. The maximum clinical wearing time is 12 month. V-Print c&b temp is a thixotropic material with an anorganic filler content of 26 % w/w. Thanks to the Viscosity Change Technology, multiple swirling is sufficient to fill the tray with V-Print c&b temp efficiently. Thanks to the composite technology, the material displays good abrasion resistance as well as high fracture resistance and is thus also ideal for long-term temporaries. V-Print c&b temp is fluorescent. The restorations can be inserted with a temporary cement or an adhesive technique.

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: 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
EBG	Crown And Bridge, Temporary, Resin	Dental	872.3770	2
POW	Crown And Bridge, Long-Term Temporary, Resin	Dental	872.3770	2

GMDN Terms

Code	Name	Definition	Implantable	Status
31783	Temporary dental crown/bridge	A prosthetic dental device intended to temporarily replace the top of a tooth or a group of teeth until a permanent restoration is fabricated. The device is typically made of plastic material [e.g., polymethylmethacrylate (PMMA)].	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	E22168971	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K231591	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 4 – 23 Degrees Celsius