Calcimol 1097

GUDID E22110971

Self-curing radiopaque calcium hydroxide paste.

VOCO GmbH

Calcium hydroxide dental cement Calcium hydroxide dental cement Calcium hydroxide dental cement Calcium hydroxide dental cement Calcium hydroxide dental cement Calcium hydroxide dental cement Calcium hydroxide dental cement Calcium hydroxide dental cement Calcium hydroxide dental cement Calcium hydroxide dental cement Calcium hydroxide dental cement Calcium hydroxide dental cement Calcium hydroxide dental cement Calcium hydroxide dental cement 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

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