Theracem Refill Package D-46311P

GUDID D757D46311P1

BISCO INC.

Dental composite resin

• Primary Device ID: D757D46311P1
• NIH Device Record Key: 9462fe7d-d3cc-4007-a682-95d53ed8aeec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Theracem Refill Package
• Version Model Number: D-46311P
• Catalog Number: D-46311P
• 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: true
• 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: 847-534-6000
• Email: sales@bisco.com
• Phone: 847-534-6000
• Email: sales@bisco.com
• Phone: 847-534-6000
• Email: sales@bisco.com
• Phone: 847-534-6000
• Email: sales@bisco.com
• Phone: 847-534-6000
• Email: sales@bisco.com
• Phone: 847-534-6000
• Email: sales@bisco.com
• Phone: 847-534-6000
• Email: sales@bisco.com
• Phone: 847-534-6000
• Email: sales@bisco.com
• Phone: 847-534-6000
• Email: sales@bisco.com
• Phone: 847-534-6000
• Email: sales@bisco.com
• Phone: 847-534-6000
• Email: sales@bisco.com
• Phone: 847-534-6000
• Email: sales@bisco.com
• Phone: 847-534-6000
• Email: sales@bisco.com
• Phone: 847-534-6000
• Email: sales@bisco.com
• Phone: 847-534-6000
• Email: sales@bisco.com
• Phone: 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
• 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
HIBCC	D757D46311P1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161256

FDA Product Code

• EMA: Cement, Dental

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-10-20
• Device Publish Date: 2017-09-01

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