BulkFill

GUDID D779600BFF1

COSMEDENT, INC.

Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin

• Primary Device ID: D779600BFF1
• NIH Device Record Key: 3f3afc7d-4f42-4113-a90a-ca8ab52c5616
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BulkFill
• Version Model Number: 600BFF
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 75 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 75 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D779600BFF1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211259

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: 2021-09-03
• Device Publish Date: 2021-08-26

On-Brand Devices [BulkFill]

• D779600BFF1: 600BFF
• D7796722B11: 6722B1
• D7796722A31: 6722A3
• D7796722A21: 6722A2
• D7796722A11: 6722A1
• D7796722351: 672235
• D7796722D21: 6722D2
• D7796722C31: 6722C3
• D7796722B01: 6722B0