Renamel® Microfill 615SB1

GUDID D779615SB10

COSMEDENT, INC.

Dental composite resin Dental composite resin

• Primary Device ID: D779615SB10
• NIH Device Record Key: b2ec48bb-8c82-4cda-bb5c-69407c7dd2d5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Renamel® Microfill
• Version Model Number: 615SB1
• Catalog Number: 615SB1
• 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	D779615SB10 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172707

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: 2018-11-08

On-Brand Devices [Renamel® Microfill]

• D779615SB30: 615SB3
• D779615SB20: 615SB2
• D779615SB10: 615SB1
• D779615A350: 615A35
• D779615A250: 615A25
• D779615A150: 615A15
• D7796151MI0: 6151MI
• D7796151LO0: 6151LO
• D7796151LI0: 6151LI
• D7796151D40: 6151D4
• D7796151D30: 6151D3
• D7796151D20: 6151D2
• D7796151CI0: 6151DI
• D7796151C50: 6151C5
• D7796151C40: 6151C4
• D7796151C30: 6151C3
• D7796151C20: 6151C2
• D7796151C10: 6151C1
• D7796151BO0: 6151BO
• D7796151B40: 6151B4
• D7796151B30: 6151B3
• D7796151B20: 6151B2
• D7796151B10: 6151B1
• D7796151A60: 6151A6
• D7796151A50: 6151A5
• D7796151A40: 6151A4
• D7796151A30: 6151A3
• D7796151A20: 6151A2
• D7796151A10: 6151A1
• D77961510W0: 61510W
• D779607A350: 607A35
• D779607A250: 607A25
• D779607A150: 607A15
• D7796073S31: 6073S3
• D7796073S21: 6073S2
• D7796073S11: 6073S1
• D7796073MI1: 6073MI
• D7796073LO1: 6073LO
• D7796073LI1: 6073LI
• D7796073DI1: 6073DI
• D7796073D41: 6073D4
• D7796073D31: 6073D3
• D7796073D21: 6073D2
• D7796073C51: 6073C5
• D7796073C41: 6073C4
• D7796073C31: 6073C3
• D7796073C21: 6073C2
• D7796073C11: 6073C1
• D7796073B41: 6073B4
• D7796073B31: 6073B3