Renamel® Microhybrid 6161A2

GUDID D7796161A20

COSMEDENT, INC.

Dental composite resin

• Primary Device ID: D7796161A20
• NIH Device Record Key: b0d3da95-208a-4247-a71a-5480f4bef25d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Renamel® Microhybrid
• Version Model Number: 6161A2
• Catalog Number: 6161A2
• 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	D7796161A20 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222435
• Premarket Notification: K921820

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: 2018-12-10
• Device Publish Date: 2018-11-09

On-Brand Devices [Renamel® Microhybrid]

• D779616MWO0: 616MWO
• D779616A350: 616A35
• D7796161MI0: 6161MI
• D7796161D40: 6161D4
• D7796161D30: 6161D3
• D7796161D20: 6161D2
• D7796161CO0: 6161CO
• D7796161C40: 6161C4
• D7796161C30: 6161C3
• D7796161C20: 6161C2
• D7796161C10: 6161C1
• D7796161BO0: 6161B0
• D7796161B40: 6161B4
• D7796161B30: 6161B3
• D7796161B20: 6161B2
• D7796161B10: 6161B1
• D7796161A40: 6161A4
• D7796161A30: 6161A3
• D7796161A20: 6161A2
• D7796161A10: 6161A1
• D77961610W0: 61610W
• D779613SB30: 613SB3
• D779613SB20: 613SB2
• D779613SB10: 613SB1
• D7796131LI0: 6131LI
• D77961310W0: 61310W
• D779606MWO0: 606MWO
• D779606A350: 606A35
• D7796062MW1: 6062MW
• D7796062MI1: 6062MI
• D7796062LI1: 6062LI
• D7796062D41: 6062D4
• D7796062D31: 6062D3
• D7796062D21: 6062D2
• D7796062CO1: 6062CO
• D7796062C41: 6062C4
• D7796062C31: 6062C3
• D7796062C21: 6062C2
• D7796062C11: 6062C1
• D7796062B41: 6062B4
• D7796062B31: 6062B3
• D7796062B21: 6062B2
• D7796062B11: 6062B1
• D7796062B01: 6062B0
• D7796062A41: 6062A4
• D7796062A31: 6062A3
• D7796062A21: 6062A2
• D7796062A11: 6062A1
• D7796062351: 606235
• D77960620W1: 60620W