Renamel® Flowable Microfill 3011C2

GUDID EDEL3011C20

Renamel® Flowable Microfill Body C2, Syringe 3g

DeltaMed GmbH

Dental composite resin

• Primary Device ID: EDEL3011C20
• NIH Device Record Key: ba13b163-d0ed-41b1-91df-5ea722505392
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Renamel® Flowable Microfill
• Version Model Number: 3011C2
• Catalog Number: 3011C2
• 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	D7793011C20 [Previous]
HIBCC	EDEL3011C20 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K974494

FDA Product Code

• EBD: Coating, Filling Material, 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 Microfill]

• EDEL301A350: Renamel® Flowable Microfill Body A3.5, Syringe 3g
• EDEL301A250: Renamel® Flowable Microfill Body A2.5, Syringe 3g
• EDEL301A150: Renamel® Flowable Microfill Body A1.5, Syringe 3g
• EDEL3011MI0: Renamel® Flowable Microfill Medium Incisal, Syringe 3g
• EDEL3011LO0: Renamel® Flowable Microfill Light Opaque, Syringe 3g
• EDEL3011LI0: Renamel® Flowable Microfill Light Incisal, Syringe 3g
• EDEL3011DI0: Renamel® Flowable Microfill Dark Incisal, Syringe 3g
• EDEL3011D40: Renamel® Flowable Microfill Body D4, Syringe 3g
• EDEL3011D30: Renamel® Flowable Microfill Body D3, Syringe 3g
• EDEL3011D20: Renamel® Flowable Microfill Body D2, Syringe 3g
• EDEL3011C50: Renamel® Flowable Microfill Body C5, Syringe 3g
• EDEL3011C40: Renamel® Flowable Microfill Body C4, Syringe 3g
• EDEL3011C30: Renamel® Flowable Microfill Body C3, Syringe 3g
• EDEL3011C20: Renamel® Flowable Microfill Body C2, Syringe 3g
• EDEL3011C10: Renamel® Flowable Microfill Body C1, Syringe 3g
• EDEL3011B40: Renamel® Flowable Microfill Body B4, Syringe 3g
• EDEL3011B30: Renamel® Flowable Microfill Body B3, Syringe 3g
• EDEL3011B20: Renamel® Flowable Microfill Body B2, Syringe 3g
• EDEL3011B10: Renamel® Flowable Microfill Body B1, Syringe 3g
• EDEL3011A60: Renamel® Flowable Microfill Body A6, Syringe 3g
• EDEL3011A50: Renamel® Flowable Microfill Body A5, Syringe 3g
• EDEL3011A40: Renamel® Flowable Microfill Body A4, Syringe 3g
• EDEL3011A30: Renamel® Flowable Microfill Body A3, Syringe 3g
• EDEL3011A20: Renamel® Flowable Microfill Body A2, Syringe 3g
• EDEL3011A10: Renamel® Flowable Microfill Body A1, Syringe 3g
• EDEL30110W0: Renamel® Flowable Microfill Body White, Syringe 3g
• EDEL3011OP0: Renamel® Flowable Microfill OPAL™, Syringe 3g