AccessGUDID - DEVICE: V-Print c&b temp (E22169001)

GUDID

Device Identifier (DI) Information

Brand Name: V-Print c&b temp
Version or Model: 6900
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 6900
Company Name: VOCO GmbH

Primary DI Number: E22169001
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 316699578 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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)].	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EBG	Crown And Bridge, Temporary, Resin
POW	Crown And Bridge, Long-Term Temporary, Resin

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K231591	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 4 and 23 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 55ae87e9-61b1-4a29-97d8-b3e9bebc845b
Public Version Date: August 25, 2023
Public Version Number: 1
DI Record Publish Date: August 17, 2023