Core-Flo DC Lite A-17801S

GUDID 00810111542227

Core-Flo DC Lite 2g Natural A1 Syr

BISCO INC.

Dental composite resin

• Primary Device ID: 00810111542227
• NIH Device Record Key: 016fda39-00ef-420b-b2dd-79947dfcffd2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Core-Flo DC Lite
• Version Model Number: A-17801S
• Catalog Number: A-17801S
• Company DUNS: 053529939
• Company Name: BISCO 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

Customer Support Contacts

• Phone: +1(847)534-6000
• Email: sales@bisco.com
• Phone: +1(847)534-6000
• Email: sales@bisco.com
• Phone: +1(847)534-6000
• Email: sales@bisco.com
• Phone: +1(847)534-6000
• Email: sales@bisco.com
• Phone: +1(847)534-6000
• Email: sales@bisco.com
• Phone: +1(847)534-6000
• Email: sales@bisco.com
• Phone: +1(847)534-6000
• Email: sales@bisco.com
• Phone: +1(847)534-6000
• Email: sales@bisco.com
• Phone: +1(847)534-6000
• Email: sales@bisco.com
• Phone: +1(847)534-6000
• Email: sales@bisco.com
• Phone: +1(847)534-6000
• Email: sales@bisco.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810111542227 [Primary]
HIBCC	D757A17801S0 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093470

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: 2022-09-27
• Device Publish Date: 2022-09-19

On-Brand Devices [Core-Flo DC Lite]

• D757A178030: Core-Flo DC Lite 8g Opaque White Syr
• D757A178010: Core-Flo DC Lite 8g Natural A1 Syr
• D757AB17410K1: Core-Flo DC Lite with Universal Primer Kit
• 00810111542234: Core-Flo DC Lite 2g Natural A1 Pkg
• 00810111542227: Core-Flo DC Lite 2g Natural A1 Syr
• 00810111542203: Core-Flo DC Lite 8g Opaque White Syr
• 00810111542180: Core-Flo DC Lite 8g Natural A1 Syr
• 00810111542210: Core-Flo DC Lite 8g Opaque White Pkg
• 00810111542197: Core-Flo DC Lite 8g Natural A1 Pkg
• 00810111542241: Core-Flo DC Lite with Universal Primer Kit