VITA ENAMIC STAIN black M700125

GUDID E239M7001251

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

Innovation MediTech GmbH

Polymer-based dental model material

• Primary Device ID: E239M7001251
• NIH Device Record Key: 8131bf4b-a1dd-44de-bd77-f7b4f8f15a0f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VITA ENAMIC STAIN black
• Version Model Number: 1
• Catalog Number: M700125
• Company DUNS: 313785693
• Company Name: Innovation MediTech GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 28 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E239M7001251 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123761

FDA Product Code

• EBD: Coating, Filling Material, Resin

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-10-18

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• E239M700101 - VITA ENAMIC GLAZE: 2018-07-06 Light-curing dental lacquer for final coating of shade customization/characterization of the surface of dental restorations. 20