Cavex Temporary Cement CE090

GUDID E241CE0900

Dental Cement

Cavex Holland B.V.

Temporary dental filling material

• Primary Device ID: E241CE0900
• NIH Device Record Key: a32a3cf9-1ecb-4581-b49b-552fa4fa01bf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cavex Temporary Cement
• Version Model Number: CE090
• Catalog Number: CE090
• Company DUNS: 419980156
• Company Name: Cavex Holland B.V.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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: +31(0)235307700
• Email: r.woortman@cavex.nl

Device Dimensions

• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E241CE0900 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K003791

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-07-07

Devices Manufactured by Cavex Holland B.V.

• E241AA6000 - Cavex Cream: 2018-07-06 Dental Alginate Impression material
• E241AA6001 - Cavex Cream: 2018-07-06 Dental Alginate Impression material
• E241CE0900 - Cavex Temporary Cement: 2018-07-06Dental Cement
• E241CE0900 - Cavex Temporary Cement: 2018-07-06 Dental Cement
• E241AA0200 - Cavex CA37 Fast Set: 2018-03-29 Dental Alginate Impression material
• E241AA0201 - Cavex CA37 Fast Set: 2018-03-29 Dental Alginate Impression material
• E241AA0250 - Cavex CA37 Fast Set: 2018-03-29 Dental Alginate Impression material
• E241AA0251 - Cavex CA37 Fast Set: 2018-03-29 Dental Alginate Impression material
• E241AA0350 - Cavex CA37 Fast Set: 2018-03-29 Dental Alginate Impression material