Renamel® Flowable Microhybrid 7011MI

GUDID EDEL7011MI0

Renamel® Flowable Microhybrid Medium Incisal, Syringe 3g

DeltaMed GmbH

Dental composite resin

• Primary Device ID: EDEL7011MI0
• NIH Device Record Key: 17add3a9-f75f-4f89-ba1f-28d2357fe687
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Renamel® Flowable Microhybrid
• Version Model Number: 7011MI
• Catalog Number: 7011MI
• 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: true
• 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

• Special Storage Condition, Specify: Between 0 and 0 *avoid direct sunlight
• Storage Environment Temperature: Between 4 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *avoid direct sunlight
• Storage Environment Temperature: Between 4 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *avoid direct sunlight
• Storage Environment Temperature: Between 4 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *avoid direct sunlight
• Storage Environment Temperature: Between 4 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *avoid direct sunlight
• Storage Environment Temperature: Between 4 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *avoid direct sunlight
• Storage Environment Temperature: Between 4 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *avoid direct sunlight
• Storage Environment Temperature: Between 4 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *avoid direct sunlight
• Storage Environment Temperature: Between 4 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *avoid direct sunlight
• Storage Environment Temperature: Between 4 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *avoid direct sunlight
• Storage Environment Temperature: Between 4 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *avoid direct sunlight
• Storage Environment Temperature: Between 4 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *avoid direct sunlight
• Storage Environment Temperature: Between 4 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *avoid direct sunlight
• Storage Environment Temperature: Between 4 Degrees Celsius and 24 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *avoid direct sunlight
• Storage Environment Temperature: Between 4 Degrees Celsius and 24 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D7797011MI0 [Previous]
HIBCC	EDEL7011MI0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222435

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: 2023-06-08
• Device Publish Date: 2023-05-31

On-Brand Devices [Renamel® Flowable Microhybrid]

• EDEL701MWO0: Renamel® Flowable Microhybrid Milky White Occlusal, Syringe 3g
• EDEL701A350: Renamel® Flowable Microhybrid Body A3.5, Syringe 3g
• EDEL7011MI0: Renamel® Flowable Microhybrid Medium Incisal, Syringe 3g
• EDEL7011D30: Renamel® Flowable Microhybrid Body D3, Syringe 3g
• EDEL7011CO0: Renamel® Flowable Microhybrid Clear Occlusal, Syringe 3g
• EDEL7011C40: Renamel® Flowable Microhybrid Body C4, Syringe 3g
• EDEL7011C30: Renamel® Flowable Microhybrid Body C3, Syringe 3g
• EDEL7011C20: Renamel® Flowable Microhybrid Body C2, Syringe 3g
• EDEL7011B30: Renamel® Flowable Microhybrid Body B3, Syringe 3g
• EDEL7011B20: Renamel® Flowable Microhybrid Body B2, Syringe 3g
• EDEL7011B10: Renamel® Flowable Microhybrid Body B1, Syringe 3g
• EDEL7011A40: Renamel® Flowable Microhybrid Body A4, Syringe 3g
• EDEL7011A30: Renamel® Flowable Microhybrid Body A3, Syringe 3g
• EDEL7011A20: Renamel® Flowable Microhybrid Body A2, Syringe 3g
• EDEL7011A10: Renamel® Flowable Microhybrid Body A1, Syringe 3g
• EDEL70110W0: Renamel® Flowable Microhybrid Body White, Syringe 3g