Calcimol 1097

GUDID E22110971

Self-curing radiopaque calcium hydroxide paste.

VOCO GmbH

Calcium hydroxide dental cement

• Primary Device ID: E22110971
• NIH Device Record Key: 58d6f42e-721d-423b-adef-732c70d04b2b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Calcimol
• Version Model Number: 1097
• Catalog Number: 1097
• Company DUNS: 316699578
• Company Name: VOCO GmbH
• 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: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx
• Phone: 999-999-9999
• Email: xxx@xx.xx

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 23 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 23 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E22110971 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K923849

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: 2016-08-31

Devices Manufactured by VOCO GmbH

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• E22162841 - GrandioSO 4U: 2025-06-10 light-curing, radiopaque nano-hybrid universal composite, syringe 4.5g, A1
• E22162851 - GrandioSO 4U: 2025-06-10 light-curing, radiopaque nano-hybrid universal composite, syringe 4.5g, A2
• E22162861 - GrandioSO 4U: 2025-06-10 light-curing, radiopaque nano-hybrid universal composite, syringe 4.5g, A3
• E22162871 - GrandioSO 4U: 2025-06-10 light-curing, radiopaque nano-hybrid universal composite, syringe 4.5g, A3.5
• E22162881 - GrandioSO 4U: 2025-06-10 light-curing, radiopaque nano-hybrid universal composite, syringe 4.5g, A4
• E22162891 - GrandioSO 4U: 2025-06-10 light-curing, radiopaque nano-hybrid universal composite, syringe 4.5g, opaque