AccessGUDID - DEVICE: VITA ENAMIC STAIN white (E239M7001211)

GUDID

Device Identifier (DI) Information

Brand Name: VITA ENAMIC STAIN white
Version or Model: 1
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: M700121
Company Name: Innovation MediTech GmbH

Primary DI Number: E239M7001211
Issuing Agency: HIBCC
Commercial Distribution End Date: August 05, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 313785693 *Terms of Use

Device Description: Colour powder for shade customization and characterization of the surface of dental restorations. 2 g bottle.

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:	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?
44727	Dental porcelain/ceramic restoration kit	A collection of containers with different shades of porcelain (ceramic based material in powder form) intended to be used in prefabricated and custom-made dental restorations, e.g., artificial teeth on copings, crowns, or bridges. This kit is typically used in the dental laboratory. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EBD	Coating, Filling Material, Resin

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K123761	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 15 and 28 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e5151b46-50dc-4364-93b7-dc153c194b85
Public Version Date: August 08, 2022
Public Version Number: 4
DI Record Publish Date: October 18, 2016