3Delta Crown 1611260

GUDID EDEL16112600

3Delta Crown C1 1000g

DeltaMed GmbH

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• Primary Device ID: EDEL16112600
• NIH Device Record Key: fb2f6b7f-4956-43e7-8826-c72038f386ec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3Delta Crown
• Version Model Number: 1611260
• Catalog Number: 1611260
• Company DUNS: 344805101
• Company Name: DeltaMed 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: true
• 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 4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *avoid direct sunlight
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *avoid direct sunlight
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *avoid direct sunlight
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *avoid direct sunlight
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *avoid direct sunlight
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *avoid direct sunlight
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *avoid direct sunlight
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *avoid direct sunlight
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *avoid direct sunlight
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *avoid direct sunlight
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *avoid direct sunlight
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *avoid direct sunlight
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *avoid direct sunlight
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *avoid direct sunlight
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *avoid direct sunlight
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *avoid direct sunlight

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EDEL16112600 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211804

FDA Product Code

• EBF: Material, Tooth Shade, Resin

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-02-21
• Device Publish Date: 2022-02-11

On-Brand Devices [3Delta Crown]

• EDEL16112600: 3Delta Crown C1 1000g
• EDEL16112350: 3Delta Crown A3.5 1000g
• EDEL16112300: 3Delta Crown A3 1000g
• EDEL16112200: 3Delta Crown A2 1000g
• EDEL16112100: 3Delta Crown A1 1000g
• EDEL16111600: 3Delta Crown C1 500g
• EDEL16111350: 3Delta Crown A3.5 500g
• EDEL16111300: 3Delta Crown A3 500g
• EDEL16111200: 3Delta Crown A2 500g
• EDEL16111100: 3Delta Crown A1 500g
• EDEL16112550: 3Delta Crown B1 1000g
• EDEL16112500: 3Delta Crown Bleach 1000g
• EDEL16111550: 3Delta Crown B1 500g
• EDEL16111500: 3Delta Crown Bleach 500g