TheraCal PT H-34010

GUDID 00810111540797

TheraCal PT 4g Dual Syr

BISCO INC.

Dental composite resin

• Primary Device ID: 00810111540797
• NIH Device Record Key: e7cace1b-a5d6-4de9-8b5d-64c50ea162df
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TheraCal PT
• Version Model Number: H-34010
• Catalog Number: H-34010
• 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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810111540797 [Primary]
HIBCC	D757H340100 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180344

FDA Product Code

• EJK: Liner, Cavity, Calcium Hydroxide

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: 2022-10-10
• Device Publish Date: 2022-09-30

On-Brand Devices [TheraCal PT]

• D757H340100: TheraCal PT 4g Dual Syr
• 00810111540797: TheraCal PT 4g Dual Syr
• 00810111540803: TheraCal PT 4g Syr Pkg
• 00810111542944: TheraCal PT 2g Syr Pkg
• 00810111542937: TheraCal PT 2g Dual Syr