BulkFill

GUDID D779600BFF1

COSMEDENT, INC.

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