AccessGUDID - DEVICE: VITA ENAMIC GLAZE (E239M700101)

GUDID

Device Identifier (DI) Information

Brand Name: VITA ENAMIC GLAZE
Version or Model: 1
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: M70010
Company Name: Innovation MediTech GmbH

Primary DI Number: E239M700101
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: Light-curing dental lacquer for final coating of shade customization/characterization of the surface of dental restorations. 20 ml 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?
45294	Dental restorative material varnish	A liquid substance used to cover dental filling material in the initial setting period after application typically to prevent moisture infiltration (especially when a dental silicate or glass ionomer cement is used as a filling material). The device typically consists of dissolved artificial resins. After application, this device 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 [?]
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: 1115bcef-6505-47df-85b1-0924873df0a3
Public Version Date: August 08, 2022
Public Version Number: 4
DI Record Publish Date: October 18, 2016