AccessGUDID - DEVICE: visio.lign color Orange (EBREVLCOLORANGE0)

GUDID

Device Identifier (DI) Information

Brand Name: visio.lign color Orange
Version or Model: VLCOLORANGE
Commercial Distribution Status: In Commercial Distribution
Catalog Number: VLCOLORANGE
Company Name: bredent GmbH & Co. KG

Primary DI Number: EBREVLCOLORANGE0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 341086190 *Terms of Use

Device Description: visio.lign color Orange 2.6 ml

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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:	No
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?
38781	Dental prosthesis veneer resin	A dental resin composite material intended to be used for veneering a restorative dental prosthesis (e.g., crown, bridge, fixed or removable denture); some types may be used as stains to apply colour to the dental appliance. After application, this material cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EBD	Coating, filling material, resin

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K240735	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
Special Storage Condition, Specify: keep out of sunlight

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: bac8cbc0-ad54-4bb9-b6c9-aa9a1379b578
Public Version Date: March 18, 2025
Public Version Number: 1
DI Record Publish Date: March 10, 2025