Renamel® Flowable Microfill 3011D2

GUDID D7793011D20

COSMEDENT, INC.

Dental composite resin

• Primary Device ID: D7793011D20
• NIH Device Record Key: 45bb5ea1-6224-4ae4-926e-0a0d1912df9b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Renamel® Flowable Microfill
• Version Model Number: 3011D2
• Catalog Number: 3011D2
• Company DUNS: 113911689
• Company Name: COSMEDENT, INC.
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D7793011D20 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-22

On-Brand Devices [Renamel® Flowable Microfill]

• D779301A350: 301A35
• D779301A250: 301A25
• D779301A150: 301A15
• D7793011MI0: 3011MI
• D7793011LO0: 3011LO
• D7793011LI0: 3011LI
• D7793011DI0: 3011DI
• D7793011D40: 3011D4
• D7793011D30: 3011D3
• D7793011D20: 3011D2
• D7793011C50: 3011C5
• D7793011C40: 3011C4
• D7793011C30: 3011C3
• D7793011C20: 3011C2
• D7793011C10: 3011C1
• D7793011B40: 3011B4
• D7793011B30: 3011B3
• D7793011B20: 3011B2
• D7793011B10: 3011B1
• D7793011A60: 3011A6
• D7793011A50: 3011A5
• D7793011A40: 3011A4
• D7793011A30: 3011A3
• D7793011A20: 3011A2
• D7793011A10: 3011A1
• D77930110W0: 30110W