VITA ENAMIC STAIN brown

Basic Information

• Brand Name: VITA ENAMIC STAIN brown
• Primary DI: E239M7001231
• Version / Model: 1
• Catalog Number: M700123
• Company Name: Innovation MediTech GmbH
• Labeler DUNS: 313785693
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-10-18
• Public Version: 4
• Public Version Date: 2022-08-08
• Public Version Status: Update
• Public Device Record Key: 30e48b99-e189-4fd3-a1b6-d55b2910a115
• Distribution End Date: 2022-08-05

Device Description

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

Device Characteristics

• Single Use: No
• 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
EBD	Coating, Filling Material, Resin	Dental	872.3310	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	E239M7001231	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K123761	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 28 Degrees Celsius