Calasept® 1230200

GUDID 17310230000078

Directa AB

Calcium hydroxide dental cement

• Primary Device ID: 17310230000078
• NIH Device Record Key: 53e2fb76-7513-4628-9a74-654072044e3a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Calasept®
• Version Model Number: Calasept
• Catalog Number: 1230200
• Company DUNS: 353954381
• Company Name: Directa AB
• Device Count: 2
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	17310230000078 [Primary]
GS1	17310230000733 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K895508

FDA Product Code

• EJK: Liner, Cavity, Calcium Hydroxide

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-23

On-Brand Devices [Calasept®]

• 17310230000078: Calasept
• 17310230000054: Calasept